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Provide structured feedback on AI accuracy in areas such as insurance regulations (state DOI requirements, NAIC guidelines), actuarial standards, and industry-specific terminology - Collaborate asynchronously with research teams to refine evaluation frameworks for insurance-domain AI **Ideal Qualifi

Remote Jobs are now available in your area. Great pay and flexible hours. Easy apply online. This position is a work from home position. You will not need to come into the office. No Experience Needed. Benefits: Health Insurance, 401K, Vacation& PTO. Apply now! Work from home roles are a critical part of our mission to deliver timely, accurate and professional customer service to all customers. This vital position requires an action-oriented, flexible problem-solver who will assist customers in expediting orders and correcting post-sales problems. Employees communicate with customers primarily through phone and email and utilize a variety of software tools to navigate customer accounts, research and review policies and communicate effective solutions in a fun and fast-paced environment.

< Overview: At Alnylam Pharmaceuticals, we are leading the RNAi Revolution, developing innovative therapies that transform the lives of patients with rare and prevalent diseases. As a Federal Account Director, you will play a key role in executing our U.S. federal market access strategy, with a primary focus on assigned Department of Veterans Affairs (VA) VISN and VA Hospital accounts, as well as supporting Department of Defense (DoD) ecosystems where applicable. This position requires expertise in the federal healthcare landscape, including VA/DoD reimbursement dynamics, formulary processes, Criteria for Use (CFU), utilization management, and stakeholder engagement, particularly for therapies requiring administration by healthcare professionals under the medical benefit. You will focus on optimizing access and appropriate utilization of Alnylam's HCP-administered products by ensuring compliant application of the VA National Formulary and CFU at your assigned accounts. In collaboration with cross-functional partners, you will educate site administrators, department chairs, and clinical influencers on the value proposition of Alnylam products for Veterans and service members. You will also support cross-functional pull-through efforts, contribute to federal access strategies, and provide insights to inform broader team initiatives. This role demands agility to navigate evolving policies, market conditions, and federal requirements while identifying opportunities to enhance product utilization. You will collaborate with internal teams, including sales, medical affairs, health economics, and strategic accounts, to align with Alnylam's commercial objectives and mission to deliver groundbreaking RNAi therapeutics to patients in federal systems. This is a field-based remote position requiring up to 50-70% travel and reports to the Senior Director, Federal Accounts. Key Responsibilities: • Execute federal access strategies within assigned VISN and VA Hospital accounts to optimize patient access and appropriate utilization of Alnylam's portfolio., • Ensure compliant application of the VA National Formulary and Criteria for Use (CFU) for Alnylam products at the site level., • Partner with the cross-functional team to ensure that critical education is delivered to key stakeholders including site administrators, department chairs, and healthcare professionals. This education includes: disease-state education, clinical information, as well as administration requirements of Alnylam's therapies., • Analyze account-specific data, trends, and utilization metrics to identify opportunities for enhanced pull-through and appropriate use., • Collaborate with field sales, Regional Business Directors, and cross-functional partners to implement pull-through tactics and support sales performance in federal accounts., • Contribute to the development and execution of account plans, sharing insights and best practices with the federal team., • Support federal market development initiatives, including engagement with organizations such as the Association of Military Surgeons of the United States (AMSUS)., • Provide federal payer and account insights to market access, HEOR, patient services, and leadership teams to inform strategies and address gaps. Accountabilities: • Build and maintain multi-level relationships within assigned federal accounts (VISNs, VA Hospitals, and related DoD entities), positioning Alnylam as a trusted partner for HCP-administered innovations benefiting Veterans and service members., • Navigate federal provider structures to engage key decision-makers, influencers, and clinical stakeholders, fostering long-term partnerships that support Alnylam's current products and pipeline., • Prioritize account activities to ensure consistent, compliant implementation of national formulary and CFU, addressing site-specific needs for medical benefit therapies., • Collaborate with internal experts (e.g., Medical Affairs, national contracting, and policy teams) to support access positioning and medical policy alignment., • Deliver tailored education on the value proposition of Alnylam products, emphasizing benefits for patient populations served in federal settings., • Review sales, utilization, and trend data to uncover pull-through opportunities, developing tactics aligned with team KPIs., • Work with field sales teams to execute pull-through plans, providing training on federal payer dynamics, formulary processes, CFU requirements, and reimbursement for HCP-administered therapies., • Maintain compliance with all legal, regulatory, and company policies in stakeholder interactions and program execution., • Contribute to team knowledge sharing by documenting best practices, participating in training, and supporting pilot programs or initiatives. Qualifications: • Bachelor's degree required (business or science preferred); advanced degree (e.g., MBA, PharmD) a plus., • Minimum 7+ years of pharmaceutical/biotech experience, with at least 3 years in account management, payer access, or related roles; direct experience in VA/DoD or federal channels preferred., • Proven track record in managing complex accounts, influencing stakeholders, and driving results in healthcare environments., • In-depth knowledge of federal healthcare systems, including VA National Formulary, Criteria for Use (CFU), VISN dynamics, aprocurement process for HCP-administered therapies, medical benefit coverage, utilization management, site-of-care strategies, and reimbursement pathways., • Strong analytical skills to interpret data, identify opportunities, and develop actionable account plans., • Consultative approach to stakeholder engagement, with expertise in value communication and educational program delivery., • Understanding of payer economics, utilization management, and evolving U.S. policies impacting federal systems., • Comprehensive knowledge of pharmaceutical operations, including prescribing, regulations, supply chain, managed care, sales, and compliance., • Excellent communication, presentation, and relationship-building skills; ability to collaborate effectively in cross-functional teams. #LI-ST1 #LI-Remote U.S. Pay Range $211,500.00 - $286,100.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

At Zelis, we Get Stuff Done. So, let's get to it! A Little About Us Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers. We serve more than 750 payers, including the top five national health plans, regional health plans, TPAs and millions of healthcare providers and consumers across our platform of solutions. Zelis sees across the system to identify, optimize, and solve problems holistically with technology built by healthcare experts - driving real, measurable results for clients. A Little About You You bring a unique blend of personality and professional expertise to your work, inspiring others with your passion and dedication. Your career is a testament to your diverse experiences, community involvement, and the valuable lessons you've learned along the way. You are more than just your resume; you are a reflection of your achievements, the knowledge you've gained, and the personal interests that shape who you are. Position Overview This role shapes strategic direction for cloud platforms and drives innovation at scale. Responsible for setting long-term cloud strategy, overseeing architecture for globally distributed systems, and guiding the organization through transformative technology initiatives. What You'll Do: * Develop long-term cloud strategy aligned with corporate objectives and digital transformation goals. * Oversee architecture for mission-critical, globally distributed systems ensuring security and compliance. * Influence vendor relationships and negotiate cloud service agreements. * Represent the organization in technical advisory boards and industry forums. * Drive adoption of innovative technologies to maintain competitive advantage. * Establish enterprise-wide disaster recovery and business continuity strategies. * Define and enforce architectural standards, development methodologies, and governance models across engineering teams. * Serve as a principal advisor to executive leadership on cloud software strategy, innovation, and risk mitigation. * Drive cross-functional collaboration with Product, Security, Infrastructure, and Data teams to ensure cohesive system design. * Author and maintain high-level technical documentation, architectural blueprints, and engineering playbooks. * Mentor senior engineers and engineering managers, fostering a culture of technical excellence and continuous learning. What You'll Bring to Zelis: * Typically has Bach. +15 yrs; Masters +12 yrs; Demonstrated accomplishment internally and externally; Has followership in subject matter area; Attends company training and regional training in area of expertise. Presents own work to members of department and external consultants and external professional societies. * Requires proficiency using AI tools skillfully with an understanding of how to develop/create intelligent prompts and/or agents. * Proven track record of delivering large-scale, complex cloud solutions. * Expertise in advanced topics such as edge computing, AI/ML integration, and zero-trust security models. * Proven track record of leading large-scale software transformations. * Strong leadership and communication skills across technical and executive audiences. Please note at this time we are unable to proceed with candidates who require visa sponsorship now or in the future. Location and Workplace Flexibility We have offices in Atlanta GA, Boston MA, Morristown NJ, Plano TX, St. Louis MO, St. Petersburg FL, and Hyderabad, India. We foster a hybrid and remote friendly culture, and all our employee's work locations are based on the needs of the position and determined by the Leadership team. In-office work and activities, if applicable, vary based on the work and team objectives in accordance with Company policies. Base Salary Range $169,000.00 - $213,750.00 At Zelis we are committed to providing fair and equitable compensation packages. The base salary range allows us to make an offer that considers multiple individualized factors, including experience, education, qualifications, as well as job-related and industry-related knowledge and skills, etc. Base pay is just one part of our Total Rewards package, which may also include discretionary bonus plans, commissions, or other incentives depending on the role. Zelis' full-time associates are eligible for a highly competitive benefits package as well, which demonstrates our commitment to our employees' health, well-being, and financial protection. The US-based benefits include a 401k plan with employer match, flexible paid time off, holidays, parental leaves, life and disability insurance, and health benefits including medical, dental, vision, and prescription drug coverage. Equal Employment Opportunity Zelis is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We welcome applicants from all backgrounds and encourage you to apply even if you don't meet 100% of the qualifications for the role. We believe in the value of diverse perspectives and experiences and are committed to building an inclusive workplace for all. Accessibility Support We are dedicated to ensuring our application process is accessible to all candidates. If you are a qualified individual with a disability or a disabled veteran and require a reasonable accommodation with any part of the application and/or interview process, please email ___. Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities, duties, and skills from time to time.

At Zelis, we Get Stuff Done. So, let's get to it! A Little About Us Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers. We serve more than 750 payers, including the top five national health plans, regional health plans, TPAs and millions of healthcare providers and consumers across our platform of solutions. Zelis sees across the system to identify, optimize, and solve problems holistically with technology built by healthcare experts - driving real, measurable results for clients. A Little About You You bring a unique blend of personality and professional expertise to your work, inspiring others with your passion and dedication. Your career is a testament to your diverse experiences, community involvement, and the valuable lessons you've learned along the way. You are more than just your resume; you are a reflection of your achievements, the knowledge you've gained, and the personal interests that shape who you are. Position Overview The Client Policy Specialist is a client facing role that will act as the subject matter expert (SME) as it pertains to Zelis editing product in support of the growth, and expansion of assigned clients. The Client Policy Specialist will lead the sales overview discussion of new/existing opportunities for the Zelis editing product during client meetings in partnership with the Client Management team. This includes, but is not limited to, review of client data to identify pre/post-production edit volume and savings, edit trends, outliers while providing rationale and potential customization options to ensure Zelis edit logic is aligned with internal policies of assigned clients and their specific Lines of Business. The Client Policy Specialist will ensure day-to-day activities of assigned team aligns with the overall mission and adherence to best practice policies as defined by the organization. What you'll do: • Demonstrate an expert level understanding of Zelis editing products with an ability to clearly articulate correct coding and claim adjudication guidelines, interpretation of client policies and present Zelis edits/editing suites to assigned clients., • Primary contact for Client Manager to support the retention and expansion of Zelis Editing Products for assigned clients., • Ability to work day-to-day with autonomy. Individual contributor as it pertains to assigned clients but works well with CPS team and provides guidance and asks questions as needed., • Proactively partner with Zelis assigned clients to assist in questions, concerns, and provide explanations regarding editing logic, CMS rules and regulations, and assist in client operational efficiencies., • Ability to recommend editing adjustments and modifications as needed to product and to the client., • Includes and identifies individual stakeholders for client meetings, needs, and solutions., • Schedule internal stakeholder meetings for new edit offerings for assigned clients., • Builds relationships internally with collaborative partners and follows processes well., • Proactively partner with Client Policy Integration Director for input regarding Pre-Stakeholder meetings to validate pre-production data and client selection based on edit volume/potential savings opportunity., • Demonstrate expertise in ability to document root-cause analysis of identified client editing issues for escalation to the appropriate Zelis internal team for resolution and communication to the client., • Proactively monitor, research, and summarize changes to client payment policy during ongoing scheduled client meetings while partnering with Client Policy Team to ensure awareness of updates and revisions to Zelis Edits., • Proactively monitor, research and present edit customizations to clients to ensure that all customizations are up-to-date and valid., • Assists in ongoing process improvement and automation., • Proactively escalate identified Zelis Editing Product issues utilizing all tools and resources to document and resolve issue., • Effectively collaborate with the Zelis Editing Product team as it pertains to editing solutions, new edit releases, and product issues., • Proactively partner with Product and Product Analytics team to obtain impact analysis with claim level details for production edits for all assigned clients to support upsell of existing/new production edit opportunities., • Partner with Client Integration Specialist and Implementation teams to support the implementation of the Zelis Edit Products for new/existing clients which includes but is not limited to edit presentation, interpreting client policies, provide guidance for requested client customizations and support testing and client "go-live"., • Effectively partner with Edit Configuration and Claims Edit Validation Team to confirm client selected edit package set up with various lines of business (when applicable), interpret intent of client requested customizations, confirm configuration of requested customizations, and support post-production validation of selected client approved edit and newly deployed edits., • Ensure compliance with HIPAA regulations and requirements. What you'll bring to Zelis: • 3 years of relevant experience or equivalent combination of education and work experience with healthcare payers, third party administrators, and health plans. Bachelor's Degree preferred * CPC or equivalent required • Current certified coder (AAPC or AHIMA) or Registered Health Information (RHIA/RHIT) certifications required., • Extensive knowledge of correct coding and industry standard claim adjudication guidelines and policies., • Extensive knowledge and ability to translate coding and adjudication guidelines, policies and references into edit policies and rules., • 3 years minimum client facing and/or provider facing experience which includes but is not limited to conducting product overview and sales workshops, • Extensive experience in managing internal/external relationships with strong Project Management skills., • Excellent verbal & written communication skills, • Proficient in Microsoft Office suite (Word, Excel, Power Point etc.), • Proficient in JIRA, • Travel requirements to (primarily) domestic destinations should not exceed 10%. Please note at this time we are unable to proceed with candidates who require visa sponsorship now or in the future. Location and Workplace Flexibility We have offices in Atlanta GA, Boston MA, Morristown NJ, Plano TX, St. Louis MO, St. Petersburg FL, and Hyderabad, India. We foster a hybrid and remote friendly culture, and all our employee's work locations are based on the needs of the position and determined by the Leadership team. In-office work and activities, if applicable, vary based on the work and team objectives in accordance with Company policies. Base Salary Range $65,000.00 - $82,650.00 At Zelis we are committed to providing fair and equitable compensation packages. The base salary range allows us to make an offer that considers multiple individualized factors, including experience, education, qualifications, as well as job-related and industry-related knowledge and skills, etc. Base pay is just one part of our Total Rewards package, which may also include discretionary bonus plans, commissions, or other incentives depending on the role. Zelis' full-time associates are eligible for a highly competitive benefits package as well, which demonstrates our commitment to our employees' health, well-being, and financial protection. The US-based benefits include a 401k plan with employer match, flexible paid time off, holidays, parental leaves, life and disability insurance, and health benefits including medical, dental, vision, and prescription drug coverage. Equal Employment Opportunity Zelis is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We welcome applicants from all backgrounds and encourage you to apply even if you don't meet 100% of the qualifications for the role. We believe in the value of diverse perspectives and experiences and are committed to building an inclusive workplace for all. Accessibility Support We are dedicated to ensuring our application process is accessible to all candidates. If you are a qualified individual with a disability or a disabled veteran and require a reasonable accommodation with any part of the application and/or interview process, please email ___. Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities, duties, and skills from time to time.

< Overview Join the Alnylam Commercial Data and Analytics team and help build a product-driven engine that turns data-driven insights into deployed decisions with measurable business impact. As part of Customer Experience and Innovation, you will work cross-functionally with technical and business partners to accelerate commercial outcomes by standardizing what we build, how we build it, and how we deliver it through the tools and workflows business users rely on every day. As Associate Director, Data Steward, you will contribute to prioritized Value Teams across the commercial organization: Business Performance & Drivers, Customer & Account Growth, Omnichannel & Media Optimization, Patient Pull-Through & Outcomes, and Evaluation & Learning. Value Teams collaborate fluidly to deliver and manage decision products that enable specific business outcomes, driving competitive foresight and actioning for the commercial organization through predictive and prescriptive analytics. In this role, you will bring product thinking to commercial data foundations by designing the gold-level models and governed metrics that make decision products reusable, trusted, and scalable. You will enforce single source of truth standards while enabling fast delivery through clear documentation, testing, and predictable data products. You will work within and across multiple Value Teams, balancing standards and stewardship with practical enablement so teams can move faster without breaking trust. The position will be based in Cambridge, MA. Key Responsibilities • Work within and across multiple Value Teams, aligning to transparent priorities and delivering governed data products that scale across franchises and markets., • Own gold-level data modeling and architecture for key commercial domains, including conformed entities and reusable dimensional models that support analytics and platforms., • Establish and maintain single source of truth metrics, including canonical definitions, lineage, documentation, and version history with disciplined change control., • Own analytics engineering standards for the gold layer, including dbt model architecture, modular design, testing, documentation, and performance considerations., • Operate data quality management, including automated tests, monitoring, incident triage, root-cause analysis, and remediation coordination with engineering partners., • Define and deliver reliable data products with SLAs for freshness and availability that support decision products and self-serve insight surfaces., • Partner with Advanced Analytics to ensure metrics reflect decision intent and are fit for measurement and learning loops, and partner with AI and ML Engineering to ensure feature inputs are stable and traceable through approved versioned pathways., • Use AI tooling to increase efficiency and throughput for documentation, profiling, and issue investigation; operate in agile delivery rhythms using Jira and GitHub-based version control for dbt projects, definitions, and related technical artifacts. Qualifications • BS degree in Data Engineering, Information Systems, Computer Science, Analytics, or related field, or equivalent experience., • 9 plus years in data engineering, data architecture, analytics engineering, or data governance, ideally in healthcare or life sciences., • Deep experience with gold-layer data modeling and architecture, including dimensional modeling and conformed dimensions., • Advanced proficiency in SQL and strong hands-on experience with dbt, including modular design, testing, documentation, and code review practices., • Experience defining and governing metrics, including lineage, metadata, access controls, stewardship workflows, and change management., • Experience using AI tooling to improve throughput and quality while maintaining accuracy, security, and governance discipline., • Strong ability to partner across functions, communicate standards clearly, and enable reuse across multiple Value Teams., • Experience working in Jira and collaborating using git-based version control in GitHub. Value Teams • Business Performance & Drivers: delivering a single, trusted view of performance, key drivers, and competitive dynamics to unlock growth through sophisticated products and skillful leadership in business reviews., • Customer & Account Growth: optimizing commercial levers across field, strategic accounts, and digital to achieve sales ambition through proactive opportunity analytics and predictive insight, productized to drive ongoing value., • Omnichannel & Media Optimization: enabling proactive management of channel mix, messaging, sequencing, and spend through data products and a centralized user console., • Patient Pull-Through and Outcomes: identifying and preventing journey drop-offs and targeting access interventions to start and sustain therapy, enabling a differentiated patient experience that continuously improves outcomes., • Evaluation & Learning: providing objective measurement of what worked and why and feeding learnings back to enable rapid optimization of commercial strategies and investment guidance. #LI-SS1 #LI-Remote U.S. Pay Range $165,800.00 - $224,200.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

< Overview: We are seeking a Director, Field Reimbursement Lead - Central to manage a regional team of field reimbursement directors. The Field Reimbursement Team is a critical component of the commercial strategy and will work in close collaboration with Sales, Patient Services, Strategic Account Management and Market Access to support Alnylam's patient-focused vision of harnessing a revolution in biology for human health. This field-based position will report to the Senior Director, Field Reimbursement and requires 50-75% travel. The successful candidate must be passionate about science and deeply motivated by the quest of delivering value to patients with the long-term success of the company in mind. This individual will have a deep and board understanding of access and reimbursement across the healthcare landscape, as well as cross-functional business knowledge to optimize access and deliver an excellent customer experience. Key Responsibilities: • Hire, lead, and empower an experienced and talented team of field reimbursement directors skilled in access, coverage, and reimbursement across all sites of care including physician office, ambulatory infusion center, hospital outpatient department and home treatment, • Foster and inspire a collaborative, inclusive and high-performing team culture that encourages accountability and embraces innovation with a purposeful sense of urgency, • Provide regular performance feedback, coaching and professional development to team members, • Partner with the Senior Director, Field Reimbursement in the development of strategy, tactics and messaging that align to Market Access priorities as well as in the creation of key performance metrics, • Utilize analytics and reporting dashboards to identify access and reimbursement issues within the region and collaborate closely with leadership from Sales, Patient Services, Strategic Account Management, and Market Access in the development of strategic solutions and action plans, • Deliver consistent guidance via team calls, field ride alongs, and meeting engagements to ensure the team is compliantly and effectively leveraging tools and materials to educate healthcare professionals, • Serve as the escalation point for regional access and reimbursement challenges, • Maintain strategic relationships with Medicare Administrative Contractors (MACs) within the region to ensure optimal coverage for Alnylam therapies and monitor Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs), • Ensure team's compliance with the appropriate ways of working across diverse cross-functional partnerships Qualifications: • Bachelor's degree required, • 10+ years of pharmaceutical/biotech experience required, • 8+ years of field reimbursement experience within a 'buy and bill' environment required, • 3+ years of leading a field reimbursement team or experience managing a field- based team preferred, • In-depth knowledge of both medical benefit and pharmacy benefit across all payer types (Medicare, Medicaid, commercial and VA/DoD) and sites of care (physician office, ambulatory infusion center, hospital outpatient department and home treatment), • Established relationships with Medicare Administrative Contractors (MACs) highly preferred, • Proven ability to identify key access and reimbursement barriers to treatment and design effective resolution plans, • Demonstrated ability to work in a highly collaborative matrix, • Desire to work in a fast-paced, energetic environment, • Self-starter who is enthusiastic about rare disease and Alnylam's core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, • Must reside in or live in close proximity to designated area of responsibility #LI-ST1 #LI-Remote U.S. Pay Range $204,000.00 - $276,000.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Company : Highmark Inc. Job Description : JOB SUMMARY This position coordinates member and provider outreach activities. The role focuses on completing non-clinical tasks, including prescriber office outreach, benefits investigations, and formulary research to ensure timely, accurate information gathering and communication. ESSENTIAL RESPONSIBILITIES * Conducts member outreach in a professional, courteous, and service-focused manner, gathers and verifies, patient information prior to transferring cases to a pharmacist, ensuring completeness and accuracy. Supports timely processing of requests by following established workflows, turnaround time expectations, and regulatory requirements. * Performs prescriber office outreach to initiate changes, obtain documentation, clarify medication information, and resolve non-clinical case needs. * Completes benefits investigations, including eligibility verification, formulary coverage clarification, and cost-share determination. * Prepares non-clinical components of medication-related cases for pharmacist review, ensuring all required information is assembled. Documents clearly, accurately, and thoroughly in all appropriate record systems, ensuring information is complete and up to date. * Serves as a liaison between members, providers, and internal pharmacy teams to resolve non-clinical issues efficiently, including identifying opportunities for improving outreach processes, documentation quality, and operational efficiency . * Escalates clinical concerns, incomplete information, or red flags or issues to pharmacists for further review and decision-making.. EXPERIENCE Required Strong knowledge of medical and pharmaceutical terminology * Strong verbal and written communication skills * Well organized, paying close attention to detail * Ability to identify and resolve problems * Ability to handle multiple priorities in a timely manner * Strong interpersonal skills * Ability to work independently or in a team environment * Customer oriented * Proficient with Microsoft Office products (i.e. Word, Excel, Powerpoint, etc.) EDUCATION Required Required * Certified Pharmacy Technician (CPhT) * Registered Pharmacy Technician in Pennsylvania and/or applicable state Preferred None Travel Requirement: 0% - 25% PHYSICAL, MENTAL DEMANDS and WORKING CONDITIONS Position Type Office- or Remote-based Teaches / trains others Occasionally Travel from the office to various work sites or from site-to-site Rarely Works primarily out-of-the office selling products/services (sales employees) Never Physical work site required No Lifting: up to 10 pounds Constantly Lifting: 10 to 25 pounds Occasionally Lifting: 25 to 50 pounds Rarely Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. Compliance Requirement : This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies. As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company's Handbook of Privacy Policies and Practices and Information Security Policy. Furthermore, it is every employee's responsibility to comply with the company's Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements. Pay Range Minimum: $19.27 Pay Range Maximum: $27.42 Base pay is determined by a variety of factors including a candidate's qualifications, experience, and expected contributions, as well as internal peer equity, market, and business considerations. The displayed salary range does not reflect any geographic differential Highmark may apply for certain locations based upon comparative markets. Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law. We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact the email below. For accommodation requests, please contact HR Services Online at California Consumer Privacy Act Employees, Contractors, and Applicants Notice Req ID: J278192

Requisition number: 2346557 Job category: Nursing Optum Insight is improving the flow of health data and information to create a more connected system. We remove friction and drive alignment between care providers and payers, and ultimately consumers. Our deep expertise in the industry and innovative technology empower us to help organizations reduce costs while improving risk management, quality and revenue growth. Ready to help us deliver results that improve lives? Join us to start Caring. Connecting. Growing together. We serve the Commonwealth of Massachusetts in partnering with onsite audits and projects. We have collaborative team scheduling and there is an occasional opportunity for remote work based on business needs. As a Sr Utilization Management Nurse in the Boston MA Regional Area, the role centers on ensuring the accuracy of medical record coding, supporting proper payment to nursing facilities, and promoting quality patient care. Responsibilities include collaborating with peers and providers to discuss care details, reviewing clinical information for appropriateness, and communicating findings and rationale to medical professionals and the broader community. Additionally, the nurse educates stakeholders about audit results and corrective plans, ensures compliance with HIPAA guidelines, and leverages clinical expertise to guide decisions and optimize patient outcomes. Qualified candidates must live in the Boston MA Regional Area to perform the daily travel responsibilities. For this role, there will be no weekends, no holidays, and no on-call work. Primary Responsibilities: * Audit entire medical record for accuracy of the coding on the MDS to support payment to the nursing facility * Auditing anti-psychotic therapy for quality review * Discuss Patient Care specifics with peers or providers in overall patient care and benefits * Communicate clinical findings and present rationale for decisions to medical professionals and members at the appropriate level for understanding * Review the entire medical record for accuracy, and appropriate clinical treatment * Communicate findings of audits to client, and community as needed * Education of findings with community, identifying plans for correction * Comply with HIPAA guidelines related to Personal Health Information (PHI) when communicating with others * Leverage experience and understanding of disease pathology to review chart/clinical information, ask appropriate questions, and identify appropriate course of care in a given situation * Perform medical chart review that includes a review of current and prior patient conditions, documents, and evaluations, and relevant social and economic situations to identify patients' needs * Research and identify information needed to review assessment for accuracy, respond to questions, or make recommendations * Apply knowledge of pharmacology and clinical treatment protocol to determine appropriateness of care * Work collaboratively with peers/team members and other levels or segments within Optum, UHC, or UBH (e.g. Case Managers, Field Care Advocates) to identify appropriate course of action (e.g. Appropriate care, follow up course of action, make referral) * Required to travel within geographic territory (state of Massachusetts) at least 90% of the time (some weeks will require 100% travel as business needs dictate) and assist when needed throughout the state of Massachusetts for audits. (Audits will be conducted onsite) You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. Required Qualifications: * Must be a Registered Nurse (RN) with a current, active, unrestricted RN License in Massachusetts * Must currently have OR be able to obtain an RAC/CT MDS certification (must have completed certification prior to start date) * 4+ years of nursing experience, specifically in long-term care and/or medical record review with knowledge of Medicare and Medicaid * Recent long-term care MMQ, MDS, staff development or management experience (in long-term care) * Experience working within medical insurance and/or healthcare industries * Experience analyzing inventory, researching, identifying, and resolving issues * Experience with defining and managing processes within a team * Experience trouble shooting issues for users within teams, IT, and/or business partners * Proven knowledge of healthcare insurance industry (Medicaid, Medicare, CMS) * Demonstrated knowledge of process flow of UM, including prior authorization, concurrent authorization, and/or clinical appeal and guidance reviews * Must live in the Boston MA Regional Area to conduct daily travel requirements * Ability to travel within geographic territory (state of Massachusetts) at least 90% of the time (some weeks will require 100% travel as business needs dictate) and assist when needed throughout the state of Massachusetts for audits. (Audits will be conducted onsite) * Must have reliable transportation and be able to provide proof of a valid, unrestricted Driver's License and current Auto Insurance Preferred Qualifications: * Proven knowledge of Medicaid and Medicare benefit products including applicable state regulations * Demonstrated knowledge of applicable area of specialization * Demonstrated knowledge of Massachusetts DPH guidelines * Demonstrated knowledge of computer functionality, navigation, and software applications * Proficiency with Microsoft Office Suite * Proficient written and verbal skills Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. The salary for this role will range from $72,800 to $130,000 annually based on full-time employment. We comply with all minimum wage laws as applicable. Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants. #OptumInsightPJ At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission. UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.

At Zelis, we Get Stuff Done. So, let's get to it! A Little About Us Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers. We serve more than 750 payers, including the top five national health plans, regional health plans, TPAs and millions of healthcare providers and consumers across our platform of solutions. Zelis sees across the system to identify, optimize, and solve problems holistically with technology built by healthcare experts - driving real, measurable results for clients. A Little About You You bring a unique blend of personality and professional expertise to your work, inspiring others with your passion and dedication. Your career is a testament to your diverse experiences, community involvement, and the valuable lessons you've learned along the way. You are more than just your resume; you are a reflection of your achievements, the knowledge you've gained, and the personal interests that shape who you are. Position Overview The Senior Manager, Provider Strategy operates within a high-growth, strategic business area focused on advancing Provider performance and will lead high-impact, cross-functional initiatives aimed at optimizing provider economics and operating model effectiveness. Key areas of focus include pricing strategy, provider retention and conversion, go-to-market testing and scaling, service model optimization, and strengthening the overall Provider Value Proposition. The role applies data-driven analysis to identify opportunities, inform strategic direction, and drive measurable business outcomes. This position partners closely with teams across Strategy, Product, Analytics, Finance, Network/Provider Relations, Sales, and Operations to ensure alignment and execution of initiatives. Reporting to the Director, Provider Strategy, this role requires strong analytical, strategic, and cross-functional leadership capabilities to support Provider priorities and performance improvement efforts. What You'll Do: * Lead the design and execution of high-impact initiatives within the Provider Performance strategy, including pricing guardrails, retention and conversion playbooks, value proposition enhancements, and market research to identify gaps and opportunities * Develop strategic frameworks, business cases, and multi-year plans to support growth, performance improvement, and transformation efforts * Partner cross-functionally with Product, Sales, Partnerships, and other stakeholders to evolve the Provider operating model and drive alignment across the organization * In collaboration with the Director, align teams around a shared strategy by establishing clear objectives, KPIs, and accountability across functions * Establish and refine business unit KPIs, performance dashboards, and analytics to track progress, inform decisions, and elevate business performance * Drive executive-level communications by synthesizing complex analyses into clear, compelling materials for senior leadership and Board of Directors presentations * Design and implement scalable process improvement frameworks to enhance operational efficiency and effectiveness across business units * Proactively identify risks and strategic gaps, escalating issues as needed and recommending actionable solutions to senior leadership * Contribute to building team culture and operating norms for a high-performing, collaborative environment * Mentor junior team members, fostering strong analytical capabilities, structured thinking, and best practices What You'll Bring to Zelis: * 6-8 years of professional experience in strategy, operations, business planning, or a related field; experience in consulting, corporate strategy, or other highly analytical environments is strongly preferred * Proven ability to structure and solve complex business problems, leveraging data and AI tools to generate insights and drive actionable recommendations and improve analysis efficiency * Strong analytical and quantitative skills, with experience building business cases, financial models, and performance frameworks * Demonstrated experience leading cross-functional initiatives and influencing stakeholders across multiple levels of an organization * Exceptional communication skills, with the ability to synthesize complex concepts into clear, compelling narratives for senior leadership * Experience developing and tracking KPIs, dashboards, and performance metrics to monitor business outcomes and inform decision-making * Ability to operate in a fast-paced, high-growth environment with a high degree of ownership, accountability, and adaptability * Strong project management and organizational skills, with the ability to manage multiple priorities and drive initiatives from concept through execution * Experience mentoring or supporting junior team members, fostering structured thinking and best practices Please note at this time we are unable to proceed with candidates who require visa sponsorship now or in the future. Location and Workplace Flexibility We have offices in Atlanta GA, Boston MA, Morristown NJ, Plano TX, St. Louis MO, St. Petersburg FL, and Hyderabad, India. We foster a hybrid and remote friendly culture, and all our employee's work locations are based on the needs of the position and determined by the Leadership team. In-office work and activities, if applicable, vary based on the work and team objectives in accordance with Company policies. Base Salary Range $139,000.00 - $176,700.00 At Zelis we are committed to providing fair and equitable compensation packages. The base salary range allows us to make an offer that considers multiple individualized factors, including experience, education, qualifications, as well as job-related and industry-related knowledge and skills, etc. Base pay is just one part of our Total Rewards package, which may also include discretionary bonus plans, commissions, or other incentives depending on the role. Zelis' full-time associates are eligible for a highly competitive benefits package as well, which demonstrates our commitment to our employees' health, well-being, and financial protection. The US-based benefits include a 401k plan with employer match, flexible paid time off, holidays, parental leaves, life and disability insurance, and health benefits including medical, dental, vision, and prescription drug coverage. Equal Employment Opportunity Zelis is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We welcome applicants from all backgrounds and encourage you to apply even if you don't meet 100% of the qualifications for the role. We believe in the value of diverse perspectives and experiences and are committed to building an inclusive workplace for all. Accessibility Support We are dedicated to ensuring our application process is accessible to all candidates. If you are a qualified individual with a disability or a disabled veteran and require a reasonable accommodation with any part of the application and/or interview process, please email ___. Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities, duties, and skills from time to time.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice () and Terms of Use () . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Purpose * Leveraging a proven track record of leading at least 3 discovery programs to clinic, The Global Therapeutic Research Lead (GTRL) is a pipeline critical strategic leader responsible for driving Research projects to the clinic. The individual will sit on the Gastroenterology and Inflammation Drug Discovery Unit (GI DDU) Leadership Team. * Leader for at least one or more of Takeda's top priority projects with substantial clinical and commercial potential with a clear accelerated path to the clinic. * You will provide mentorship to team members to elevate enterprise thinking and capabilities of our drug discovery talent across the global Research function. * As project lead, the GTRL builds a connected view of the project within the Gastroenterology and Inflammation TA strategy and treatment paradigm and can represent all core expertise at depth and align with stakeholders and sponsors across the organization including Research, Clinical Development and Commercial stakeholders and executive level governance committees. * The GTRL will be responsible for creating the medicine vision, early asset strategy and managing multiple external partnerships that accelerate delivery of the project. * The GTRL will establish smart, fast, and critical path minded practices for groups, including integrating new strategies and competitive industry ways of working. * The GTRL will advise on the continuous infusion of new Research projects aligned to strategy to generate a sustainable Research Engine generating a steady flow of high-quality INDs every year. Accountabilities * Lead and manage one or more 'Top 10' drug discovery projects, overseeing the entire drug discovery process from target identification to preclinical development. (Top 10 projects are well validated targets that are focused on strategically aligned modalities with substantial clinical and commercial potential) * Responsible for the articulation and ownership of the project strategy, developed in partnership with internal stakeholders. * Contribute to strategy for future portfolio investment, particularly within the Inflammation and Immunology area including advising on which projects should be Top 10 projects. * Evaluate and prioritize potential drug candidates based on scientific, medical, and commercial considerations. * Represent all core expertise for the project. * Partner with Clinical and Translational teams to refine asset strategy. * Ensure alignment to the therapeutic area strategy (i.e., Clinical Development). * Understand and align with the commercial team for asset commercial value within the TA. * Provide guidance and mentorship to global project team members, stimulating enterprise thinking and fostering their professional growth and development. * Mentor future and more junior project leads and elevate drug discovery capability across Research. * Collaborate with cross-functional teams and partners (e.g., DMPK, Pharmaceutical Sciences) within and outside Takeda to drive project delivery. * Pipeline and enterprise impact through effective partnering with multiple internal and external collaborators. * Provide strategic, process, and operational leadership for successful Top 10 Project delivery. * Foster a culture of innovation and scientific excellence within the matrixed drug discovery team, promoting collaboration, knowledge sharing, and continuous learning. * Become a world leading scientific expert in the projects you lead. * Oversee the design and execution of experiments, data analysis, and interpretation to enable decision-making and optimize drug discovery efforts. * Stay abreast of the latest advancements in drug discovery, emerging technologies, and industry trends, applying this knowledge to enhance drug discovery strategies. * Build and maintain relationships with key stakeholders, including academic institutions, research organizations, and industry partners inclusive of serving on joint external governance committees across the globe. * Represent Takeda externally for the Gastroenterology and Inflammation Drug Discovery Unit and play a key role in evaluating external opportunities, serving as an effective ambassador for Takeda's global business development brand. Education & Competencies (Technical and Behavioral): * PhD degree in a scientific discipline with 15+ years experience , orMS with 21+ years experience, or BS with 23+ years experience * Expected to have at least 10-12 years industry and relevant subject matter expertise within Immunology and Inflammation and at least 10-12 years global management experience, including working effectively with matrix teams. * Extensive experience in leading drug discovery teams and managing drug discovery/development projects, preferably in a pharmaceutical or biotechnology setting covering gastroenterology and inflammation. * Deep understanding of the drug discovery process, including target identification, hit-to-lead optimization, and preclinical development, anticipating, and removing roadblocks. * Proven track record of leading numerous projects, ideally 5+ projects, across discovery from target inception to Candidate Nomination or beyond. * Played a major role in 3+ INDs. * Has delivered clinical development assets, must include experience with biologics and preferably across multiple modalities. * Excellent and inclusive leadership with the ability to inspire and motivate diverse teams towards achieving ambitious goals. * Reputation as a proactive, solutions-oriented leader who engages relevant expertise no matter where it resides. * Strong business acumen and understanding of the pharmaceutical industry, including regulatory requirements and commercial considerations with relevant knowledge and expertise for specific modalities. * Exceptional communication and presentation skills, with the ability to effectively communicate complex scientific concepts to diverse audiences. * Proven ability to build and maintain collaborative relationships with internal and external stakeholders across a matrixed organization. * Strong problem-solving and decision-making abilities, with a focus on data-driven decision making. * Demonstrated success in building and managing strategic partnerships with academic institutions, research organizations, and industry collaborators. ADDITIONAL INFORMATION We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

< Overview: We are seeking an experienced Medical Science Liaison (MSL) to join the TTR team and support Alnylam's commitment to advancing the science and care of patients with transthyretin (TTR) amyloidosis. Patients often experience prolonged diagnostic journeys; this role is an opportunity to help elevate disease understanding and support evidence-based clinical decision-making through high-quality scientific exchange. The MSL will be principally responsible for building and sustaining scientific partnerships with key opinion leaders (KOLs), investigators, and other healthcare professionals within an assigned geography. The MSL will identify and address unmet medical education needs, deliver balanced scientific information (including mechanism of action and emerging clinical data), and gather actionable medical insights to inform internal stakeholders. Success in this role is grounded in Alnylam's core values-our unwavering commitment to people, purposeful urgency, passion for excellence, fiercely innovative, and an open culture-while upholding the highest standards of integrity and compliance. This position partners closely with cross-functional colleagues (including Medical Affairs, Clinical Development, Market Access, and Patient Advocacy) to support strategic medical priorities for the TTR franchise and reports to the geographically aligned Field Medical Director. Key Responsibilities: • Partner closely with investigators and internal stakeholders to drive patient accrual., • Identify key opinion leaders and cultivate a network of experts for key Alnylam disease areas., • Develop, maintain, and execute US KOL and US Institution plans within respective geography., • Conduct and implement a comprehensive disease awareness tactical plan within the respective geography., • Collaborate with health care professionals to identify opportunities for the development of algorithms and guidelines to facilitate early diagnosis, • Provide in-depth drug mechanism of action and emerging clinical information to health care providers in the respective geography., • Serve as a liaison to health care professionals and professional organizations and disease state advocacy groups. Support the efforts of patient support groups and educational foundations., • Provide medical and scientific input into the planning and execution of advisory boards and work with experts to review speaker presentations and provide additional medical background where requested., • Contribute to Alnylam's achievement of Company objectives for pre-approved products., • Provide educational meeting support at scientific congresses., • Coordinate required medical, legal, and regulatory review and approval of all field documents for distribution or presentation., • Require 60-70% travel. Qualifications: • PhD, PharmD, DNP or MD with 3 to 5 years' industry experience., • Proven clinical background to enable engagement of Health Care Professionals in a scientifically meaningful exchange., • Prior experience in cardiology and rare disease strongly preferred., • Experience in clinical research, patient recruitment, and investigator-sponsored trials., • Experience in medical education and KOL management., • Effective communication of evidence based scientific information., • Ability to work collaboratively and cross-functionally., • Capable of managing shifting priorities in a rapidly changing environment, • Decision-making and accountability. #LI-ST1 #LI-Remote U.S. Pay Range $187,700.00 - $253,900.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

At Zelis, we Get Stuff Done. So, let's get to it! A Little About Us Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers. We serve more than 750 payers, including the top five national health plans, regional health plans, TPAs and millions of healthcare providers and consumers across our platform of solutions. Zelis sees across the system to identify, optimize, and solve problems holistically with technology built by healthcare experts - driving real, measurable results for clients. A Little About You You bring a unique blend of personality and professional expertise to your work, inspiring others with your passion and dedication. Your career is a testament to your diverse experiences, community involvement, and the valuable lessons you've learned along the way. You are more than just your resume; you are a reflection of your achievements, the knowledge you've gained, and the personal interests that shape who you are. Position Overview We are seeking a dynamic and experienced leader for our Associate AI Enablement initiative. This highly visible role will bring the power of GenAI to every Zelis associate. The mission will include driving the adoption of agents and co-pilots that can enhance associate productivity, such as MS co-pilot integrations into Office, GitHub co-pilot for software engineering, and custom agents for role specific tasks. You will advise on technology selection and deployment and drive associate training, AI literacy, and enablement. You will develop and deploy methods to measure the impact of AI and GenAI on overall productivity. If you have a track record of working across functions to drive adoption of transformative technologies, we want to talk to you! Job Posting Title Director, AIEmpowerment Job Description Summary We are seeking a dynamic and experienced leader for our Associate AIEmpowermentinitiative. This highly visible role will bring the power of GenAI to every Zelis associate. The mission will include driving the adoption ofAIagents andassistantsthat can enhance associate productivity, such asChatGPT, GitHub copilotand Cursorfor software engineering, and custom agents for role specific tasks. You will advise on technology selection and deployment andsupportassociate training, AI literacy, andempowerment. You will develop and deploy methods to measure the impact of AI and GenAI on overall productivity. This role will also continuously monitor the rapidly evolving AI technology landscape - including major foundation model providers and enterprise application vendors used by Zelis - translating emerging capabilities into actionable recommendations aligned to Zelis' AI strategy and business priorities. The Director will partner closely with executive leadership to ensure AI initiatives are aligned to enterprise value creation goals, supporting leadership visibility into adoption, ROI, and measurable business outcomes. If you have a track record of working across functions to drive adoption of transformative technologies, we want to talk to you! Job Description Key Responsibilities * Supportthe Associate AIEmpowermentinitiative at Zelis to evangelize, translate the AI agenda, set realistic expectations and measures of success across functions. * Act as a strategic bridge between enterprise AI strategy and functional execution, ensuring AI initiatives are aligned to measurable business outcomes including productivity gains, scale enablement, cost efficiency, and product innovation. * Expand GenAI capabilities to all Zelis associates, evolving our current platforms to enable associate self-serve custom agent development. * Drive adoption of AI agents andassistantsto enhance productivity, including: * The Zelis enterprise chat agent and integrations into the Zelis office suite. * Software development agents, such as GitHub copilotand Cursor. * Custom agents tailored to role-specific tasks. * Applications of Agentic AI workflows that connect custom agents with enterprise data and tools using the Model Context Protocol (MCP) * Advise on technology selection and deployment for GenAI tools. * Evaluate emerging AI tools, vendor capabilities, and industry advancements, providing informed recommendations on strategic fit, scalability, governance considerations, and ROI potential. * Work closely with the Learning and Development group to promote associate training and AI literacy across the organization. * Enable AI usage through structured programs and support. * Build and nurture a network of AI champions across job families to accelerate cultural adoption and drive sustained behavioral change. * Work with leaders across the organization to define, implement, and continuously refine standardized ROI and value realization frameworks to assess AI and GenAI contributions to productivity, efficiency, innovation velocity, and cost avoidance. * Develop dashboards and reporting mechanisms that provide clear visibility into AI adoption, usage patterns, and measurable business impact. * Partner with executive leadership to support preparation of AI impact narratives and metrics for senior leadership and board-level discussions, as requested. What You'll Bring to Zelis * Bachelor's Degree and/or master's degree with focuses in Data Science, Computer Science, Machine Learning or related and 5 years of experiencesupportingcross functional teams with a focus on technology enablement. * Successful experience driving enablement and adoption of AI/ML related technologies across regulated, global organizations. * Proven track record of collaboration across teams, ability to influence and build global teams. * Strong presentation, influence and communication skills. * Strong understanding and experience with Healthcare IT solutions or comparable highly regulated environments. * Demonstrated experience quantifying business value and ROI from emerging technology initiatives, including defining measurable KPIs and tracking realized outcomes. * Strong awareness of current trends in foundation models, enterprise AI platforms, and agentic workflows, with the ability to translate industry advancements into practical enterprise applications. * Experience supporting executive-level decision-making through data-driven insights and structured impact reporting. * Working knowledge of AI governance, risk, and compliance considerations in regulated environments. Please note at this time we are unable to proceed with candidates who require visa sponsorship now or in the future. Location and Workplace Flexibility We have offices in Atlanta GA, Boston MA, Morristown NJ, Plano TX, St. Louis MO, St. Petersburg FL, and Hyderabad, India. We foster a hybrid and remote friendly culture, and all our employee's work locations are based on the needs of the position and determined by the Leadership team. In-office work and activities, if applicable, vary based on the work and team objectives in accordance with Company policies. Base Salary Range $169,000.00 - $213,750.00 At Zelis we are committed to providing fair and equitable compensation packages. The base salary range allows us to make an offer that considers multiple individualized factors, including experience, education, qualifications, as well as job-related and industry-related knowledge and skills, etc. Base pay is just one part of our Total Rewards package, which may also include discretionary bonus plans, commissions, or other incentives depending on the role. Zelis' full-time associates are eligible for a highly competitive benefits package as well, which demonstrates our commitment to our employees' health, well-being, and financial protection. The US-based benefits include a 401k plan with employer match, flexible paid time off, holidays, parental leaves, life and disability insurance, and health benefits including medical, dental, vision, and prescription drug coverage. Equal Employment Opportunity Zelis is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We welcome applicants from all backgrounds and encourage you to apply even if you don't meet 100% of the qualifications for the role. We believe in the value of diverse perspectives and experiences and are committed to building an inclusive workplace for all. Accessibility Support We are dedicated to ensuring our application process is accessible to all candidates. If you are a qualified individual with a disability or a disabled veteran and require a reasonable accommodation with any part of the application and/or interview process, please email ___. Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities, duties, and skills from time to time.

At Zelis, we Get Stuff Done. So, let's get to it! A Little About Us Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers. We serve more than 750 payers, including the top five national health plans, regional health plans, TPAs and millions of healthcare providers and consumers across our platform of solutions. Zelis sees across the system to identify, optimize, and solve problems holistically with technology built by healthcare experts - driving real, measurable results for clients. A Little About You You bring a unique blend of personality and professional expertise to your work, inspiring others with your passion and dedication. Your career is a testament to your diverse experiences, community involvement, and the valuable lessons you've learned along the way. You are more than just your resume; you are a reflection of your achievements, the knowledge you've gained, and the personal interests that shape who you are. Position Overview As part of the Price Optimization division, this role is responsible for conducting post-service, pre-payment and post pay comprehensive inpatient DRG Quality Assurance reviews in an effort to increase the savings achieved for Zelis clients. Conduct reviews on inpatient DRG claims as they compare with medical records utilizing ICD-10 Official Coding Guidelines, AHA Coding Clinic evidence based clinical criteria and client specific coverage policies. What you'll do: • Perform comprehensive inpatient DRG validation Quality Assurance reviews to determine accuracy of the DRG billed, based on industry standard coding guidelines and the clinical evidence supplied by the provider in the form of medical records such as physician notes, lab tests, images (x-rays etc.), and with due consideration to any applicable medical policies, medical best practice, etc., • Implement and conduct quality assurance program to ensure accurate results to our clients, • Manage assigned claims and claim report, adhering to client turnaround time, and department Standard Operating Procedures, • Serve as the Subject Matter Expert on DRG validation to team members and other departments within the organization, • Prepare and conduct training for new team members, • Identify new DRG coding concepts to expand the DRG product, • Meet and/or exceed all internal and department productivity and quality standards, • Must remain current in all national coding guidelines including Official Coding Guidelines, AHA Coding Clinic and AMA CPT Assistant, • Recommend efficiencies and process improvements to improve departmental procedures, • Maintain awareness of and ensure adherence to Zelis standards regarding privacy What you'll bring to Zelis: • Registered Nurse licensure preferred, • Inpatient Coding Certification required (i.e., CCS, CIC, RHIA, RHIT), • 5+ years reviewing and/or auditing ICD-10 CM, MS-DRG and APR-DRG claims preferred, • Solid understanding of audit techniques, identification of revenue opportunities and financial negotiation with providers, • Experience and working knowledge of Health Insurance, Medicare guidelines and various healthcare programs, • Strong understanding of hospital coding and billing rules, • Clinical and critical thinking skills to evaluate appropriate coding, • Strong organization skills with attention to detail, • Excellent communication skills both verbal and written, and skilled at developing and maintaining effective working relationships., • Demonstrated thought leadership and motivation skills, a self-starter with an ability to research and resolve issues Please note at this time we are unable to proceed with candidates who require visa sponsorship now or in the future. Location and Workplace Flexibility We have offices in Atlanta GA, Boston MA, Morristown NJ, Plano TX, St. Louis MO, St. Petersburg FL, and Hyderabad, India. We foster a hybrid and remote friendly culture, and all our employee's work locations are based on the needs of the position and determined by the Leadership team. In-office work and activities, if applicable, vary based on the work and team objectives in accordance with Company policies. Base Salary Range $95,000.00 - $120,650.00 At Zelis we are committed to providing fair and equitable compensation packages. The base salary range allows us to make an offer that considers multiple individualized factors, including experience, education, qualifications, as well as job-related and industry-related knowledge and skills, etc. Base pay is just one part of our Total Rewards package, which may also include discretionary bonus plans, commissions, or other incentives depending on the role. Zelis' full-time associates are eligible for a highly competitive benefits package as well, which demonstrates our commitment to our employees' health, well-being, and financial protection. The US-based benefits include a 401k plan with employer match, flexible paid time off, holidays, parental leaves, life and disability insurance, and health benefits including medical, dental, vision, and prescription drug coverage. Equal Employment Opportunity Zelis is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We welcome applicants from all backgrounds and encourage you to apply even if you don't meet 100% of the qualifications for the role. We believe in the value of diverse perspectives and experiences and are committed to building an inclusive workplace for all. Accessibility Support We are dedicated to ensuring our application process is accessible to all candidates. If you are a qualified individual with a disability or a disabled veteran and require a reasonable accommodation with any part of the application and/or interview process, please email ___. Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities, duties, and skills from time to time.

< Overview We are looking for an experienced and talented Business Account Executive (BAE) to commercially represent GIVLAARI and OXLUMO in the United States and have a significant impact on the lives of AHP patients. AHP's represent a sub-group of Porphyrias, characterized by the occurrence of neuro-visceral attacks with or without cutaneous manifestations. AHP's include four disorders: acute intermittent porphyria (the most common), variegate porphyria, hereditary coproporphyria, and a genetic deficit of delta-aminolaevulinic acid dehydratase. PH1 is a rare, life-threatening disease that can cause serious damage to kidneys and progressively to other organs. PH1 is a little-known condition and patients often spend years undiagnosed and misdiagnosed. The BAE will be principally responsible for driving physician and patient identification, disease awareness, overall market development, and brand awareness within their ascribed territory. The BAE will be responsible for achieving territory targets and other business objectives through account and customer strategies, while also partnering & collaborating very closely with internal and external stakeholders to effectively manage all aspects of the regional business. The achievement of targets will be based in Alnylam's values: our commitment to people, sense of urgency, passion for excellence, innovation & discovery, and open culture as well as our unwavering commitment to integrity. The BAE will report to the Regional Business Director (RBD) for their respective region. Key Responsibilities • Drive patient identification through appropriate HCP driven strategies including market development, increase brand awareness through building and executing a territory strategy/account plan; continuously assess opportunities within markets and accounts to launch successfully., • Effectively prioritize and manage time, activities, and resources in order to optimize access to academic and community HCPs., • Build and maintain relationships with HCPs and office staff by maximizing their time through planning, leveraging insights, and conducting post-call analysis refining tactics based on opportunities., • Proactively build effective working relationships with internal/external stakeholders; drive agreement/decisions from multiple stakeholders; demonstrated high level of emotional intelligence adapting communication based on different stakeholders., • Collaborate with stakeholders across all commercial departments including; patient services, field reimbursement, and others to ensure access at site of care and that logistics are in place to administer medications., • Collaborate with key accounts and physicians to build individual account plans to drive patient identification through market development and physician education; achieve sales goals, and maintain relationships in order to maximize sales results., • Execute speaker programs, local sponsorships, displays and exhibits, both in and out of office across multiple account types: academic institutions, physician offices, infusion centers, and alternate site locations., • Routinely report territory-level market dynamics and trends, including prescriber opinion and competitive activity to RBD as required. Qualifications • Bachelor's degree required., • 5+ years of demonstrated success in biotech, specialty pharmaceuticals, or medical devices., • Experience, success and relationships in Rare Disease, Gastroenterology, Hepatology, Neurology, Hematology/Oncology, pediatric and adult Nephrology and/or Urology are preferred but not required., • Buy & Bill understanding and experience working with HUB patient services preferred but not required., • Thorough understanding of site of care identification, development and education., • Strong examples of applied entrepreneurial mindset, business analytics and data analysis required., • Experience supporting biologic therapy administered by designated HCPs preferred., • Experience driving, leading and delivering upon territory-level cross functional business planning., • Must be familiar with relevant legal and regulatory environment in biotech/pharmaceutical industry., • Strong communication and listening skills., • Effective at managing complex individualized cases in a compliant manner., • Overnight travel required including travel to Boston, congresses and large geographical territories., • Candidates must have a valid driver's license., • Must live in the assigned territory. #LI-KB2 #LI-Remote U.S. Pay Range $144,500.00 - $195,500.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

At Zelis, we Get Stuff Done. So, let's get to it! A Little About Us Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers. We serve more than 750 payers, including the top five national health plans, regional health plans, TPAs and millions of healthcare providers and consumers across our platform of solutions. Zelis sees across the system to identify, optimize, and solve problems holistically with technology built by healthcare experts - driving real, measurable results for clients. A Little About You You bring a unique blend of personality and professional expertise to your work, inspiring others with your passion and dedication. Your career is a testament to your diverse experiences, community involvement, and the valuable lessons you've learned along the way. You are more than just your resume; you are a reflection of your achievements, the knowledge you've gained, and the personal interests that shape who you are. Position Overview The Director, People & Culture (P&C) AI Product Management is accountable for building and scaling a high-impact portfolio of AI and automation solutions across People & Culture. This role is not about experimentation alone - it is about scaled impact. You will own the end-to-end product lifecycle process - from intake and prioritization through deployment, adoption, and value realization - while ensuring alignment with enterprise AI strategy, governance, and risk standards. This role blends product discipline and delivery with strategic fluency. You will translate P&C needs into scalable AI/automation solutions, drive measurable efficiency gains, and ensure tools meaningfully improve Associate and People Leader experience. What You'll Do: Strategic Alignment & Governance * Define and maintain the P&C AI framework, including guiding principles, risk boundaries, build-vs-buy criteria, and enterprise alignment. * Establish and maintain a prioritized multi-quarter AI roadmap focused on high-value, scalable use cases. * Ensure cross-COE initiatives align with enterprise AI standards and risk controls. * Evaluate emerging AI tools and vendors to inform strategic decisions. Product Ownership & Delivery * Own the P&C AI product portfolio, including intake, prioritization process, backlog management, and delivery sequencing. * Serve as Product Owner for P&C AI/automation initiatives requiring Enterprise Technology partnership. * Deliver cross-COE AI use cases with measurable impact and ensure POCs progress to scaled development. * Define clear problem statements, success criteria, KPIs, and value realization models. * Track outcomes, performance, and ROI across the AI portfolio. Adoption, Experience & Change Enablement * Increase AI adoption and weekly touchpoints across the P&C function. * Enhance the AI experience within P&C workflows to reduce friction and improve productivity. * Lead change management efforts to drive sustainable adoption and behavior shift. * Create communication channels to crowdsource ideas, share wins, and build engagement around AI strategy. Leadership & Collaboration * Operate as a trusted advisor on AI-enabled transformation within P&C. * Lead and develop a small, but mighty geographically distributed team (U.S. and India). * Deep collaboration and partnership with the P&C Technology team will be imperative to success in the role. * Partner cross-functionally across COEs to identify AI/automation opportunities and scale solutions. * Collaborate closely with enterprise technology, data, and analytics teams to accelerate delivery. What You'll Bring to Zelis: * 10+ years experience in HR, digital transformation and/or product management; knowledge of HR workflows and HCM systems preferred * Demonstrated experience owning project/program/product portfolios and driving measurable outcomes. * Strong understanding of AI/automation tools and enterprise governance considerations. * Proven ability to translate strategy into delivered solutions. * Strong change leadership and stakeholder influence skills. Please note at this time we are unable to proceed with candidates who require visa sponsorship now or in the future. Location and Workplace Flexibility We have offices in Atlanta GA, Boston MA, Morristown NJ, Plano TX, St. Louis MO, St. Petersburg FL, and Hyderabad, India. We foster a hybrid and remote friendly culture, and all our employee's work locations are based on the needs of the position and determined by the Leadership team. In-office work and activities, if applicable, vary based on the work and team objectives in accordance with Company policies. Base Salary Range $153,000.00 - $193,800.00 At Zelis we are committed to providing fair and equitable compensation packages. The base salary range allows us to make an offer that considers multiple individualized factors, including experience, education, qualifications, as well as job-related and industry-related knowledge and skills, etc. Base pay is just one part of our Total Rewards package, which may also include discretionary bonus plans, commissions, or other incentives depending on the role. Zelis' full-time associates are eligible for a highly competitive benefits package as well, which demonstrates our commitment to our employees' health, well-being, and financial protection. The US-based benefits include a 401k plan with employer match, flexible paid time off, holidays, parental leaves, life and disability insurance, and health benefits including medical, dental, vision, and prescription drug coverage. Equal Employment Opportunity Zelis is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We welcome applicants from all backgrounds and encourage you to apply even if you don't meet 100% of the qualifications for the role. We believe in the value of diverse perspectives and experiences and are committed to building an inclusive workplace for all. Accessibility Support We are dedicated to ensuring our application process is accessible to all candidates. If you are a qualified individual with a disability or a disabled veteran and require a reasonable accommodation with any part of the application and/or interview process, please email ___. Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities, duties, and skills from time to time.

< Overview: At Alnylam Pharmaceuticals, we are leading the RNAi Revolution, developing innovative therapies that transform the lives of patients with rare and prevalent diseases. As a Federal Account Director, you will play a key role in executing our U.S. federal market access strategy, with a primary focus on assigned Department of Veterans Affairs (VA) VISN and VA Hospital accounts, as well as supporting Department of Defense (DoD) ecosystems where applicable. This position requires expertise in the federal healthcare landscape, including VA/DoD reimbursement dynamics, formulary processes, Criteria for Use (CFU), utilization management, and stakeholder engagement, particularly for therapies requiring administration by healthcare professionals under the medical benefit. You will focus on optimizing access and appropriate utilization of Alnylam's HCP-administered products by ensuring compliant application of the VA National Formulary and CFU at your assigned accounts. In collaboration with cross-functional partners, you will educate site administrators, department chairs, and clinical influencers on the value proposition of Alnylam products for Veterans and service members. You will also support cross-functional pull-through efforts, contribute to federal access strategies, and provide insights to inform broader team initiatives. This role demands agility to navigate evolving policies, market conditions, and federal requirements while identifying opportunities to enhance product utilization. You will collaborate with internal teams, including sales, medical affairs, health economics, and strategic accounts, to align with Alnylam's commercial objectives and mission to deliver groundbreaking RNAi therapeutics to patients in federal systems. This is a field-based remote position requiring up to 50-70% travel and reports to the Senior Director, Federal Accounts. Key Responsibilities: • Execute federal access strategies within assigned VISN and VA Hospital accounts to optimize patient access and appropriate utilization of Alnylam's portfolio., • Ensure compliant application of the VA National Formulary and Criteria for Use (CFU) for Alnylam products at the site level., • Partner with the cross-functional team to ensure that critical education is delivered to key stakeholders including site administrators, department chairs, and healthcare professionals. This education includes: disease-state education, clinical information, as well as administration requirements of Alnylam's therapies., • Analyze account-specific data, trends, and utilization metrics to identify opportunities for enhanced pull-through and appropriate use., • Collaborate with field sales, Regional Business Directors, and cross-functional partners to implement pull-through tactics and support sales performance in federal accounts., • Contribute to the development and execution of account plans, sharing insights and best practices with the federal team., • Support federal market development initiatives, including engagement with organizations such as the Association of Military Surgeons of the United States (AMSUS)., • Provide federal payer and account insights to market access, HEOR, patient services, and leadership teams to inform strategies and address gaps. Accountabilities: • Build and maintain multi-level relationships within assigned federal accounts (VISNs, VA Hospitals, and related DoD entities), positioning Alnylam as a trusted partner for HCP-administered innovations benefiting Veterans and service members., • Navigate federal provider structures to engage key decision-makers, influencers, and clinical stakeholders, fostering long-term partnerships that support Alnylam's current products and pipeline., • Prioritize account activities to ensure consistent, compliant implementation of national formulary and CFU, addressing site-specific needs for medical benefit therapies., • Collaborate with internal experts (e.g., Medical Affairs, national contracting, and policy teams) to support access positioning and medical policy alignment., • Deliver tailored education on the value proposition of Alnylam products, emphasizing benefits for patient populations served in federal settings., • Review sales, utilization, and trend data to uncover pull-through opportunities, developing tactics aligned with team KPIs., • Work with field sales teams to execute pull-through plans, providing training on federal payer dynamics, formulary processes, CFU requirements, and reimbursement for HCP-administered therapies., • Maintain compliance with all legal, regulatory, and company policies in stakeholder interactions and program execution., • Contribute to team knowledge sharing by documenting best practices, participating in training, and supporting pilot programs or initiatives. Qualifications: • Bachelor's degree required (business or science preferred); advanced degree (e.g., MBA, PharmD) a plus., • Minimum 7+ years of pharmaceutical/biotech experience, with at least 3 years in account management, payer access, or related roles; direct experience in VA/DoD or federal channels preferred., • Proven track record in managing complex accounts, influencing stakeholders, and driving results in healthcare environments., • In-depth knowledge of federal healthcare systems, including VA National Formulary, Criteria for Use (CFU), VISN dynamics, aprocurement process for HCP-administered therapies, medical benefit coverage, utilization management, site-of-care strategies, and reimbursement pathways., • Strong analytical skills to interpret data, identify opportunities, and develop actionable account plans., • Consultative approach to stakeholder engagement, with expertise in value communication and educational program delivery., • Understanding of payer economics, utilization management, and evolving U.S. policies impacting federal systems., • Comprehensive knowledge of pharmaceutical operations, including prescribing, regulations, supply chain, managed care, sales, and compliance., • Excellent communication, presentation, and relationship-building skills; ability to collaborate effectively in cross-functional teams. #LI-ST1 #LI-Remote U.S. Pay Range $211,500.00 - $286,100.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

At Zelis, we Get Stuff Done. So, let's get to it! A Little About Us Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers. We serve more than 750 payers, including the top five national health plans, regional health plans, TPAs and millions of healthcare providers and consumers across our platform of solutions. Zelis sees across the system to identify, optimize, and solve problems holistically with technology built by healthcare experts - driving real, measurable results for clients. A Little About You You bring a unique blend of personality and professional expertise to your work, inspiring others with your passion and dedication. Your career is a testament to your diverse experiences, community involvement, and the valuable lessons you've learned along the way. You are more than just your resume; you are a reflection of your achievements, the knowledge you've gained, and the personal interests that shape who you are. Position Overview Leads complex security initiatives and provides expert guidance on threat mitigation, compliance, and architecture. Your Team & Role The Cyber Defense Engineer builds, manages, and enhances tools, automations, and data systems that power cyber defense operations. The role involves hands-on work with security technologies, developing workflow efficiencies, supporting detection engineering, ensuring high-quality security data, and mentoring teammates to strengthen overall team capability. Key Responsibilities * Innovation: Identify capability gaps, propose solutions, and design modern defensive approaches. * Automation: Build or enhance automated workflows to reduce manual effort, improve reliability, and accelerate detection/response. * Tooling Management: Maintain, optimize, and troubleshoot security platforms, custom tools, and log pipelines across the enterprise. * Enterprise Data Management: Oversee the lifecycle of security data-ingestion, transformation, normalization, and quality control across systems. * Detection Management: Support detection engineering through maintenance, testing, and improvement of detection logic, rules, dashboards, and data sources. * Mentoring: Guide junior engineers and analysts on tools, processes, automation practices, and new capabilities. Here is What You Can Expect on a Typical Day * Tune, fix, integrate, or enhance security tools. * Build or update automation scripts/workflows for incident response, threat intelligence, and vulnerability management. * Maintain data pipelines by validating log sources, troubleshooting gaps, updating parsers, and improving normalization. * Review and build detection rules/alerts, collaborating with analysts to reduce noise and improve performance. * Work with IT, cloud, networking, and security teams to deploy solutions or resolve tool issues. * Write documentation, improve runbooks, and share lessons learned. * Support teammates through technical guidance and demonstrations. * Participate in discussions on innovation, process improvement, and future engineering projects. * Perform additional tasks as assigned. Qualifications: * Bachelor of Computer Science, Engineering, Information Security, Information Technology, or 4+ years of equivalent experience. * 4+ years of enterprise level cybersecurity detection, response, or engineering experience. * Ability to collaborate across enterprise teams within a cybersecurity context * Strong oral/written communication skills with experience in cybersecurity technical process documentation. * Demonstrated passion for cyber defense and commitment to maintaining technical proficiency * Proven innovation and non-traditional problem solving * Advanced knowledge of SIEM, SOAR, malware sandboxing and related tools * Experience building or maintaining automation scripts or workflows (e.g., Python, PowerShell, Bash, APIs). * Ability to diagnose and solve complex technical issues across tools, data flows, and integrations. * Experience mentoring or training others on tools, techniques, or processes. * Strong problem-solving mindset with an interest in improving systems and workflows. * Understanding of detection logic, threat behaviors, and MITRE ATT&CK. Preferred qualifications: * Advanced cybersecurity certifications (e.g., GCFA, GCIA, GNFA, GCTI, GREM, GCIH, GCFA, GPEN, OSCP, etc.). * Experience with cloud environments (AWS, Azure, GCP) and associated security tooling. * Advanced Proficiency in scripting and high-level programming languages (Python, PowerShell, bash, etc.) Please note at this time we are unable to proceed with candidates who require visa sponsorship now or in the future. Location and Workplace Flexibility We have offices in Atlanta GA, Boston MA, Morristown NJ, Plano TX, St. Louis MO, St. Petersburg FL, and Hyderabad, India. We foster a hybrid and remote friendly culture, and all our employee's work locations are based on the needs of the position and determined by the Leadership team. In-office work and activities, if applicable, vary based on the work and team objectives in accordance with Company policies. Base Salary Range $127,000.00 - $160,550.00 At Zelis we are committed to providing fair and equitable compensation packages. The base salary range allows us to make an offer that considers multiple individualized factors, including experience, education, qualifications, as well as job-related and industry-related knowledge and skills, etc. Base pay is just one part of our Total Rewards package, which may also include discretionary bonus plans, commissions, or other incentives depending on the role. Zelis' full-time associates are eligible for a highly competitive benefits package as well, which demonstrates our commitment to our employees' health, well-being, and financial protection. The US-based benefits include a 401k plan with employer match, flexible paid time off, holidays, parental leaves, life and disability insurance, and health benefits including medical, dental, vision, and prescription drug coverage. Equal Employment Opportunity Zelis is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We welcome applicants from all backgrounds and encourage you to apply even if you don't meet 100% of the qualifications for the role. We believe in the value of diverse perspectives and experiences and are committed to building an inclusive workplace for all. Accessibility Support We are dedicated to ensuring our application process is accessible to all candidates. If you are a qualified individual with a disability or a disabled veteran and require a reasonable accommodation with any part of the application and/or interview process, please email ___. Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities, duties, and skills from time to time.

At Zelis, we Get Stuff Done. So, let's get to it! A Little About Us Zelis is modernizing the healthcare financial experience across payers, providers, and healthcare consumers. We serve more than 750 payers, including the top five national health plans, regional health plans, TPAs and millions of healthcare providers and consumers across our platform of solutions. Zelis sees across the system to identify, optimize, and solve problems holistically with technology built by healthcare experts - driving real, measurable results for clients. A Little About You You bring a unique blend of personality and professional expertise to your work, inspiring others with your passion and dedication. Your career is a testament to your diverse experiences, community involvement, and the valuable lessons you've learned along the way. You are more than just your resume; you are a reflection of your achievements, the knowledge you've gained, and the personal interests that shape who you are. Position Overview The Strategic Client Executive (SCE) serves as the primary executive point of contact for Zelis' Property & Casualty (P&C) clients, managing a strategic book of large, complex carriers, TPAs, and risk-bearing organizations within the specialty vertical. This role is focused on driving enterprise value across Zelis solutions that support workers' compensation, auto/liability, and other casualty lines of business. The Strategic Client Executive (SCE) serves as the primary executive point of contact for Zelis' Property & Casualty (P&C) clients, managing a strategic book of large, complex carriers, TPAs, and risk-bearing organizations within the specialty vertical. This role is focused on driving enterprise value across Zelis solutions that support workers' compensation, auto/liability, and other casualty lines of business. The SCE partners with clients to optimize medical cost containment strategies, payment integrity, provider network performance, electronic payments, and healthcare communication solutions that directly impact claim lifecycle efficiency and regulatory compliance. The SCE will drive growth by achieving annual revenue targets, ensuring client retention, expanding product adoption, and delivering measurable outcomes tied to operational efficiency - all while delivering a superior OneZelis customer experience. This role requires deep expertise in claims operations, including medical bill review, fee schedule compliance, utilization management, subrogation opportunities, provider network access, and payment workflows, along with the ability to collaborate cross-functionally to advance client objectives. What you'll do: * Client Relationship Building: Maximize the breadth and depth of relationships by working closely with clients to intimately understand their business strategies, needs, and challenges as well as how Zelis supports the achievement of those goals. * Revenue Management: Manage and oversee revenue targets, including budgets, forecasts, and product utilization review for the assigned book of business. * Client Renewals & Retention: Responsible for client renewals and retention. Successfully lead contract negotiations and manage the complete life cycle to renew client agreements while looking for ways to expand the partnership. * Risk Identification and Mitigation: Proactively identify and mitigate risks such as volume decreases, service gaps, and changes in client relationships. * Product Knowledge & Optimization: Drive revenue growth through existing product optimization, understand and communicate key differentiators, product strategy, features, and functionality with deep knowledge of the property and casualty space. * Client Growth: Successfully uncover and qualify opportunities for growth to deliver great client value. Collaborate with sales to present innovative solutions and grow existing client base. Identify up and cross-sell opportunities to flag for Sales. * Client Value: Effectively illustrate and validate client outcomes consistently, leveraging client reporting and knowledge of client's business goals and measures. * Conduct Client Business Reviews: Conduct and lead all client business reviews and account plans to optimize value with the client's book of business. * Client Advocacy: Ensure industry leading quality service delivery and client satisfaction; measurements include proactive client management, timely escalation and resolution of issues, and nurture clients into loyal promoters. Secure client references and permission in support of key Zelis initiatives and case studies as needed. What you'll bring to Zelis: * Bachelor's degree in business or health care administration or equivalent experience. * 10+ years' experience in strategic client management. Knowledge within Property & Casualty, workers compensation or Auto liability insurance is strongly preferred. * Demonstrated success in revenue management and increased utilization within an assigned book of businessof enterprise and strategic clients. * Ability to think strategically and act proactively * Excellent written and verbal communication skills. Excellent presentation, public speaking, and meeting management capabilities. Ability to tailor messages to audiences. * Deep Understanding of the Client's Business: Understand the client in terms of markets they operate in, competitors, objectives, and challenges. Successfully build strategic account plans to fully understand client's pain and business drivers. * Develop Trusting Relationships: Cultivates deep relationships with clients and team. * Executive Communicator: Proactively communicates. Can effectively prepare and present communications to clients and executive leadership teams. * Problem Solver: The ability to offer and communicate compelling solutions to client challenges is invaluable. * Industry Knowledge: Keeping an ear to the ground in terms of market intelligence and relevant industry news. * Financial Acumen: Strong financial acumen and ability to interpret client financials. Commission-driven and motivated to achieve growth targets. * Innovative Thinking: Brings creative insight to client's businesses to help them deliver a competitive advantage. * Collaborator: Actively partners across BUs to communicate client needs & issues, shares and provides awareness of external trends and competitor landscape. * Troubleshooting: Forward looking, keeps an eye out for potential internal/external problems and managing potential concerns. Please note at this time we are unable to proceed with candidates who require visa sponsorship now or in the future. Location and Workplace Flexibility We have offices in Atlanta GA, Boston MA, Morristown NJ, Plano TX, St. Louis MO, St. Petersburg FL, and Hyderabad, India. We foster a hybrid and remote friendly culture, and all our employee's work locations are based on the needs of the position and determined by the Leadership team. In-office work and activities, if applicable, vary based on the work and team objectives in accordance with Company policies. Base Salary Range $127,000.00 - $160,550.00 At Zelis we are committed to providing fair and equitable compensation packages. The base salary range allows us to make an offer that considers multiple individualized factors, including experience, education, qualifications, as well as job-related and industry-related knowledge and skills, etc. Base pay is just one part of our Total Rewards package, which may also include discretionary bonus plans, commissions, or other incentives depending on the role. Zelis' full-time associates are eligible for a highly competitive benefits package as well, which demonstrates our commitment to our employees' health, well-being, and financial protection. The US-based benefits include a 401k plan with employer match, flexible paid time off, holidays, parental leaves, life and disability insurance, and health benefits including medical, dental, vision, and prescription drug coverage. Equal Employment Opportunity Zelis is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We welcome applicants from all backgrounds and encourage you to apply even if you don't meet 100% of the qualifications for the role. We believe in the value of diverse perspectives and experiences and are committed to building an inclusive workplace for all. Accessibility Support We are dedicated to ensuring our application process is accessible to all candidates. If you are a qualified individual with a disability or a disabled veteran and require a reasonable accommodation with any part of the application and/or interview process, please email ___. Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities, duties, and skills from time to time.

Company Overview: Business Integration Partners (BIP) is Europe’s fastest growing digital consulting company and are on track to reach the Top 20 by 2030, with an expanding global footprint in the US (New York, Philadelphia, Boston, Charlotte, Chicago, Houston). Operating at the intersection of business and technology we design, develop, and deliver sustainable solutions at pace and scale creating greater value for our customers, employees, shareholders, and society. BIP specializes in high-impact consulting services across multiple industries with 6,000 employees worldwide. Our industry domains include Life Sciences, Financial Services, Energy, and Retail, supplemented with Data & AI, Cybersecurity, Risk & Compliance, Change Management and Digital Transformation practices. We integrate deep industry expertise with business, technology, and quantitative disciplines to deliver high-impact results for our clients. BIP is currently expanding its footprint in the United States, focusing on growing its Life Sciences business within global pharmaceuticals and biotechnology. Our teams operate at the intersection of business strategy, technology, and data to help our clients in driving smarter decisions, reducing risks, and staying ahead in a fast-evolving market environment. Specific Opportunity: BIP US is seeking to grow its US consulting team and is looking for a Senior Consultant or Manager with 3 to 10 years of professional management consulting or industry experience within the pharmaceutical, biotechnology, or life sciences industries to join our US consulting team. What you will be doing: • Working with internal teams and clients across different aspects of life sciences such as Global Pharma and Biotech., • Collaborating with Bip US and BIP Global team members on mixed projects of variable size., • Applying your multiple skills such as: process design, content writing, vendor/ stakeholder management IT, or data management in coordination with your life sciences subject matter knowledge in areas like: Regulatory Compliance, Manufacturing, Supply Chain, Clinical Trials, Laboratory Management, Submission, or Quality Systems., • Engaging in internal initiatives, communities, Centers of Excellence, and intellectual capital development., • Engaging with BIP US colleagues through networking, coaching, and mentoring to further the organization’s, and your professional, goals., • Seeking business development opportunities through your client exposure, supporting proposals and other client engagement efforts across the team. Requirements: • Minimum 3-10 years in an external client facing role as a Consultant or other relevant experience., • Industry experience in Pharmaceuticals, Biotechnology, or Life Sciences., • Strong investigative, analytical, interpersonal, and communication (verbal, written and listening) skills., • Exposure to aspects of the pharmaceutical/life sciences value chain noted above., • Experience in process design, content writing, IT, or data science., • Ability to work independently as well as in teams., • Experience presenting and preparing/facilitating workshops., • A team-oriented, inclusive mindset and ability to work with a wide range of individuals., • Strong stakeholder management and consensus building skills., • A flexible approach to work with a focus on delivery to deadlines and high standards., • An eye for new project opportunities, new revenue streams and ways of working, as well as turning new ideas into reality., • Bachelor’s degree in science, engineering, computer science, business, or a related field. An advanced degree is desirable. The base salary range for this role is $110,000-$160,000 Benefits: • Choice of medical, dental, vision insurance., • Voluntary benefits., • Short- and long-term disability., • HSA and FSAs., • Matching 401k., • Discretionary performance bonus., • Employee referral bonus., • Employee assistance program., • 11 public holidays., • 20 days PTO., • 7 Sick Days., • PTO buy and sell program., • Volunteer days., • Paid parental leave., • Remote work environment with ability to travel to office as needed. For more information about BIP US, visit ___. It is BIP US Consulting policy to provide equal employment opportunities to all individuals based on job-related qualifications and ability to perform a job, without regard to age, gender, gender identity, sexual orientation, race, color, religion, creed, national origin, disability, genetic information, veteran status, citizenship, or marital status, and to maintain a non-discriminatory environment free from intimidation, harassment or bias based upon these grounds. BIP US provides a reasonable range of compensation for our roles. Actual compensation is influenced by a wide array of factors including but not limited to skill set, education, level of experience, and knowledge.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability.This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes.We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.How you will contribute:Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements.Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes.Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities.Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics.Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings.Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact.Promote sustainable practices and scalability in site-level regulatory operations.Minimum Requirements/Qualifications:BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Strong practical experience with global HA requirements, beyond EU/US.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.Analyze issues with attention to detail.Ability to assess alternative approaches.Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines.Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary.Applies directions taken by the company.Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture.Applies given prioritization framework with limited support.Excellent written and oral communication skills required. Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as hybrid following Takedas Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1 Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Boston, MAU.S. Base Salary Range:$177,000.00 - $278,080.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance.Establish best practices and builds a strong regulatory community across Global Regulatory Affairs spanning device, combination product, quality, clinical, development and manufacturing interfaces.Serve as an influential leader internally and externally, shaping regulatory policy and cross-functional decision-making for devices and combination products across major regions (e.g., US, EU, UK, Japan,China).How you will contribute:Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances.Partners with cross-functional leaders (Regulatory, Development, Clinical, Quality, Safety, Manufacturing, Supply Chain, Market Access, and Medical) to align evidence generation, usability/human factors, risk management, and value messaging to regulatory and access requirements for devices and combination products.Ensures line management and key stakeholders are apprised of developments impacting regulatory success (e.g., design changes, nonconformances, clinical evidence, labeling/UDI, post-market signals). Anticipates risks and drives mitigation plans consistent with ISO 14971, design controls, and applicable global regulations.Represents Global Regulatory Affairs in senior-level governance and in interactions with global regulators and notified bodies, including FDA (CDRH/CDER and Office of Combination Products), EMA/Competent Authorities under EU MDR, MHRA, PMDA, and other agencies as applicable.Accountable for ensuring global submissions and lifecycle compliance for devices and combination products (e.g., IDE, 510(k), De Novo, PMA, CE marking under MDR, technical documentation, variations/changes, vigilance). Partners with regional leads, quality, and vendors to ensure compliant, inspection-ready processes and documentation.Leads departmental and cross-functional initiatives to improve regulatory strategy, operational excellence, and quality systems interfaces (e.g., design controls, labeling governance, supplier controls, post-market surveillance, digital/connected device considerations). Influences without authority across R&D and Global Regulatory Affairs.Provides regulatory strategy leadership for business development and due diligence activities, including assessment of device/combination product classification, regulatory pathways, technical evidence requirements, and lifecycle obligations.Monitors and anticipates global regulatory trends impacting devices and combination products (e.g., MDR implementation, FDA guidance, standards such as ISO 13485/14971/IEC 62304, cybersecurity expectations), translating insights into proactive regulatory and evidence strategies.Responsible for demonstrating Takeda leadership behaviors.Minimum Requirements/Qualifications: Advanced degree in a scientific, or engineering discipline (e.g., MS, PhD, PharmD)20+ years of industry experience with 10+ years in Regulatory Affairs and demonstrated leadership in medical devices and/or drug-device combination products.Significant experience leading, reviewing, authoring, or managing regulatory submissions for devices and/or combination products (e.g., IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation), including major deficiency responses and negotiation of requirements.Strong working knowledge of device and combination product development and regulatory requirements, including FDA (CDRH/CDER/OCP), EU MDR/IVDR, and post-market/vigilance obligations; experience with other regions a plus.Understands and interprets complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to device/combination regulatory requirements and strategy.Provides expert guidance on global device/combination regulatory strategy, including technical documentation/Design History File expectations, design controls, human factors/usability, biocompatibility, software and cybersecurity considerations (as applicable), and post-market lifecycle planning.Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovativeSolutions and strategies, including risk mitigation strategies.Must work well with others and within global teams. Able to bring working teams together for common objectives.Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as hybrid following Takedas Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Boston, MAU.S. Base Salary Range:$238,000.00 - $374,000.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability.This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes.We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.How you will contribute:Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements.Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes.Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities.Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics.Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings.Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact.Promote sustainable practices and scalability in site-level regulatory operations.Minimum Requirements/Qualifications:BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. 10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Strong practical experience with global HA requirements, beyond EU/US.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.Analyze issues with attention to detail.Ability to assess alternative approaches.Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines.Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary.Applies directions taken by the company.Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture.Applies given prioritization framework with limited support.Excellent written and oral communication skills required. Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork. More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1 Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Boston, MAU.S. Base Salary Range:$177,000.00 - $278,080.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

TriZetto Product Solutions Inside Sales Associate (remote) This remote position is open to any qualified candidate living in the United States. Purpose: Drive new revenue for TriZetto Provider Solutions and Cognizant RCM by leveraging strong Revenue Cycle Management (RCM) sales expertise. This role focuses on engaging prospects and channel partners from lead generation through close, ensuring solutions align with provider revenue cycle needs. Essential Functions: * Sell TPS & Cognizant products and services with a strong emphasis on RCM solutions tailored to medical providers, including clearinghouse, claims management, and payment optimization tools. * Develop and grow opportunities through proactive outreach via phone, email, virtual meetings, and occasional in-person visits (<10%)-while collaborating internally with Marketing and Vendor Sales/Support. * Consultative selling: Assess client revenue cycle challenges and recommend TPS/Cognizant solutions that improve financial performance and operational efficiency. * Maintain accurate records of all leads, opportunities, and activities in CRM systems. Required Qualifications: Bachelor's degree in: Business, Healthcare Management, or related discipline. Equivalent experience may substitute for formal education. Experience: * Minimum 3 year of successful inside sales experience required. * Strong background in RCM sales selling solutions such as Practice Management, EMR, clearinghouse, or claims processing to physician practices or healthcare organizations. * Proven ability to document sales activities in a CRM (Salesforce preferred). Technical Competencies: * Proficiency in CRM tools (Salesforce preferred). * Familiarity with healthcare revenue cycle processes and terminology. Salary and Other Compensation: Applications will be accepted until April 20, 2026.The annual salary for this position is between $55,000 - $75,000 depending on experience and other qualifications of the successful candidate.This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans. Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:- Medical/Dental/Vision/Life Insurance- Paid holidays plus Paid Time Off- 401(k) plan and contributions- Long-term/Short-term Disability- Paid Parental Leave- Employee Stock Purchase PlanDisclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law. Cognizant will only consider applicants for this position who are legally authorized to work in the United States without requiring company sponsorship now or at any time in the future Cog2026 Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Director, Clinical Data Standards based remotely reporting to the Vice President, Clinical Data Operations & Standards. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: In collaboration with the Clinical Data Strategy & Operations Leaders, and TAU Leaders, and other functional area leadership to develop, establishes and drives strategy of Takeda’s global data standards, processes and technologies across the clinical data continuum for quality of deliverables and global data interoperability. Responsible for establishing and managing a Standards vendor to support Standards Management vision. Responsible for end-to-end Standards Governance to ensure proper utilization, adherence to standards governance and processes, and the ongoing, thorough assessment of library enhancements and deviations. Build relationships across the global Takeda organization and with vendor partners in support of the standards vision and implementation. Participates with and influences at industry standards forums in support of Takeda’s therapeutic areas. Serves as a resource to support questions raised by regulatory agencies. A CCOUNTABILITIES: Has advanced knowledge of all standard library components and metadata across data collection, analysis and reporting continuum. Works with Clinical Data Strategy & Operations Leaders, TAU Leaders, and other functional area leadership to develop, and adhere to, Standards Management vision and overall metadata management strategy. Leads cross-functional Standards initiatives internal or external to Takeda and helps to ensure coherence of standards initiatives across organization. Provides strategic guidance toward execution of comprehensive data continuum to staff and vendors acting as project managers or leads on cross-functional initiatives. Supervises staff and vendors developing standards library to ensure alignment to standards strategy. Develops training strategy and ensures consistent training program for standards. Provides senior oversight to vendor/CROs for utilization of Takeda standards. Conducts ongoing review and development of metrics to assess standards utilization and development trends. Oversees Standards Governance, managing deviations from standards content and processes. Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, SCDM, EDC users group, SAS users group, Third Party Data Acquisition groups, etc. Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Takeda organization. Complies with all applicable regulatory expectations. EDUCATION AND EXPERIENCE: BS/BA or MS in a life science or analytical area. 12 years data management and/or database or statistical programming experience in pharmaceutical industry or health related field. 8 years of experience supporting clinical trials across all phases of development. 5 years of progressive management experience. Proven track record for development and management of a standards library. In-depth knowledge of data management systems and processes, analysis and reporting principles. Good knowledge of statistical programming languages (e.g. SAS). Technical expertise (e.g. Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS. Expertise in the requirements and technology required to support electronic data capture and electronic submissions. Proven track record in identifying and implementing organization-wide initiatives, standards, and processes. Proven track record in managing global, cross-functional standards and processes. Knowledge of medical and statistical terminology. Comprehensive understanding of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc.) Able to influence without authority. Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo. Pragmatic and willing to drive and support change. Is comfortable with ambiguity . Support a culture of continual improvement and innovation; promote knowledge sharing. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $212,000.00 - $333,190.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. LI-Remote

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.Objective / Purpose: The Director, High-Throughput In Vitro ADME is a senior scientific and operational leader responsible for building and directing Takeda’s high-throughput in vitro ADME capabilities in support of small- and large-molecule discovery programs.Reporting to the Head of Drug Discovery Lab Automation and Transformation, this Director will define strategy, oversee operations, and drive technology innovation at the interface of ADME science, laboratory automation, and robotics. The organization will operate as a service-oriented group, delivering robust, high-quality ADME data to enable rapid, high-confidence decision-making in Design–Make–Test–Analyze (DMTA) cycles across the portfolio.Accountabilities: Strategic Leadership & VisionDefine and execute the multi-year strategic roadmap for high-throughput in vitro ADME at Takeda, aligned with the broader vision of the Drug Discovery Lab Automation and Transformation organization.Shape an enterprise-level, service-oriented operating model for ADME, ensuring capacity, capability, and flexibility to meet evolving project and portfolio needs.Champion innovation in high throughput assay design, detection technologies, automation, and data workflows to enhance throughput, quality, and cost-effectiveness.Team Leadership & People DevelopmentLead, mentor, and grow a team of scientists and research associates responsible for the routine delivery of a comprehensive suite of in vitro ADME assays.Build a culture of scientific rigor, operational excellence, safety, and customer focus, supported by clear KPIs (e.g., cycle time, success rate, capacity utilization, cost-per-data point).Drive talent development and performance management appropriate for a Director-level organization.High-Throughput ADME OperationsOversee design, execution, and continuous improvement of a broad high throughout in vitro ADME panel, including but not limited to:Metabolic stability and clearance (microsomes, hepatocytes, S9)CYP inhibition and inductionPermeability (e.g., Caco-2, MDCK, PAMPA)Plasma protein and tissue bindingTransporter and other mechanistic assaysEnsure robust support for both small-molecule and large-molecule modalities, adapting methods for new modalities and platforms as the portfolio evolves.Own and maintain fit-for-purpose validation, QC, and SOP frameworks, including root-cause analysis and corrective actions for assay or system deviations.Laboratory Automation, Robotics & MiniaturizationProvide scientific and strategic leadership for laboratory automation and robotics within the in vitro ADME space, in close alignment with the Head of Drug Discovery Lab Automation and Transformation.Lead assay miniaturization up to 1536-well formats, from feasibility and optimization through technology transfer into robust, routine operation.Oversee integration of liquid handlers, plate handlers, robotic arms, incubators, readers, and scheduling software into end-to-end automated workflows.Partner with internal automation/engineering and informatics teams to ensure seamless connectivity between instruments, LIMS/ELN, data pipelines, and analytical platforms.Cross-Functional CollaborationServe as the primary ADME service leader interfacing with DMPK, medicinal chemistry, biology, pharmacology, translational sciences, and data science.Translate portfolio and project needs into clear ADME assay strategies, capacity plans, and timelines; communicate priorities, risks, and trade-offs with transparency at project and governance levels.Collaborate with external CROs, technology vendors, and academic partners when appropriate, ensuring consistent quality standards and strategic alignment with internal capabilities.Quality, Compliance & Continuous ImprovementEnsure scientific quality, data integrity, and safety in all ADME operations, consistent with Takeda policies and relevant regulatory expectations.Define and monitor KPIs for throughput, on-time delivery, reproducibility, and cost; apply data-driven methodologies (e.g., Lean, Six Sigma, DoE) to drive continuous improvement.Oversee investigations and CAPA implementation related to assay performance, automation reliability, or data issues.Education and Experience:Expected: Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field with 10+ years of relevant industry experience; or M.S. with 16+ years; or B.S. with 18+ years in pharmaceutical/biotech R&D.Extensive expertise in in vitro ADME, including method development, validation, and deployment across core assay types.Direct experience in an organization providing ADME services (e.g., CRO or internal ADME service group), with a strong service- and customer-oriented mindset.Proven leadership experience at the Director level, managing scientific teams and complex operations in a high-throughput environment.Demonstrated strategic and hands-on experience with laboratory automation and robotics, including selection, implementation, and lifecycle managemet.Successful track record in miniaturizing ADME assays formats, including optimization for data quality, robustness, and throughput.Experience supporting both small- and large-molecule discovery programs.Familiarity with LIMS/ELN, instrument integration, and data analysis/visualization tools in a high-throughput setting.Proven track record of:Building or transforming high throughput ADME capabilities (e.g. establishing new platforms, scaling capacity, modernizing legacy workflows.Understanding how ADME outputs integrate with DMPK, PK/PD and translational strategies and inform decision makingExperience with data science and process optimization approaches to support advanced analytics, and continuous improvementADDITIONAL INFORMATIONThe position will be based in Cambridge, MA.This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policyTakeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Boston, MAU.S. Base Salary Range:$177,000.00 - $278,080.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters. Interacts directly with international Health Authorities on administrative procedural topics, as required. Evaluates change proposals for global regulatory impact. As a GRA CMC member, ensures regulatory compliance with HA regulations. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Supports and/ or leads assigned global regulatory submissions (e.g., Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. BS/BA Degree in a Scientific Discipline, Advanced Degree (M.10+ years of overall biopharmaceutical/device industry experience with 5+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered). ~ Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. ~ Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. ~ Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. ~ Able to deal with issues of critical importance with minimal supervision. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. #The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. S. based employees may be eligible for short-term and/ or long-term incentives. S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will: * Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. * Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. * Are a leader within the department and within R&D contributing to department and cross functional Takeda initiatives and influencing the field as applicable. * Provide leadership/contributes as global regulatory lead (GRL) responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. * The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed in line with changing regulatory and business needs. * Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement, and communicating in a professional and timely manner. * Proactively anticipates risks and develops solutions/scenario planning for identified risks and discussing with team and management; understands probabilities of technical success for the solutions. * Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of project(s). The Associate Director will lead all submission types. * Serves as the primary FDA contact. Leads and manages FDA meetings. * Responsible for demonstrating Takeda leadership behaviors. Manages junior staff as needed. * Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. * Participates with influence in departmental and cross-functional task-forces and initiatives. * Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen * product development plan(s) and adopt regulatory strategies in a timely manner. * Supports the lead regulatory reviewer in due diligence for licensing opportunities. * BSc Degree, preferred. BA accepted. * 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience. * Preferred experience in reviewing, authoring, or managing components of regulatory submissions. * Solid working knowledge of drug development process and regulatory requirements. * Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. * Understand and interpret complex scientific issues across multiple projects as it related to * regulatory requirements and strategy. * Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. * Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. * Demonstrates solid, increasingly independent regulatory strategy skills, including an understanding of core regulatory concepts and their organizational and global implications. * Proactively identifies regulatory issues and proposes creative, practical solutions and strategies, including risk mitigation. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: * With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. * Has a strong and deep foundational understanding of global RA CMC regulations and guidelines. Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions. * Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. * Successfully communicates and negotiates with Health Authorities – directly and indirectly. * Able to apply GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. * With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy * Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. * With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters. * Interacts directly with international Health Authorities on administrative procedural topics, as required. * Fosters constructive working relationships when interacting with internal and/or external colleagues. * Evaluates change proposals for global regulatory impact. * As a GRA CMC member, ensures regulatory compliance with HA regulations. Assures conformance with Takeda controlled procedures and GRA CMC best practices. * Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. * Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. * When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. * Supports and/ or leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. * Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target. * Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. * BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. * 10+ years of overall biopharmaceutical/device industry experience with 5+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered). * Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. * Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. * Analyze issues with attention to detail. * Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. * Able to deal with issues of critical importance with minimal supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management. * Understands who is responsible for different decisions and escalates as necessary. * Applies decisions taken by the company. * Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. * Intentionally promotes an inclusive culture. * Applies the given prioritization framework with limited support. * Excellent written and oral communication skills required. * Exercises good judgement in elevating and communicating actual or potential issues to line management. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

A leading law firm in Boston is looking for an experienced Insurance Coverage Attorney to manage complex insurance disputes and provide expert advice to policyholders.The successful candidate will gain courtroom experience and collaborate with skilled trial attorneys.This position offers a competiti

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: • Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects., • Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements., • Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable., • Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: • The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible., • Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy., • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner., • Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions., • Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types., • Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs., • Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed., • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products., • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope., • Participates with influence in or leads departmental and cross-functional task-forces and initiatives., • Lead regulatory reviewer in due diligence for licensing opportunities., • Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable., • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner., • Responsible for demonstrating Takeda leadership behaviors. Education & Competencies: • Bachelor's Degree, scientific discipline strongly preferred, • Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred, • 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4+ years regulatory and/or related experience., • Preferred experience in reviewing, authoring, or managing components of regulatory submissions., • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus., • Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy., • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy., • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability., • Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies., • Must work well with others and within global teams., • Able to bring working teams together for common objectives., • Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Purpose Leveraging a proven track record of leading at least 3 discovery programs to clinic, The Global Therapeutic Research Lead (GTRL) is a pipeline critical strategic leader responsible for driving Research projects to the clinic. The individual will sit on the Gastroenterology and Inflammation Drug Discovery Unit (GI DDU) Leadership Team. Leader for at least one or more of Takeda’s top priority projects with substantial clinical and commercial potential with a clear accelerated path to the clinic. You will provide mentorship to team members to elevate enterprise thinking and capabilities of our drug discovery talent across the global Research function. As project lead, the GTRL builds a connected view of the project within the Gastroenterology and Inflammation TA strategy and treatment paradigm and can represent all core expertise at depth and align with stakeholders and sponsors across the organization including Research, Clinical Development and Commercial stakeholders and executive level governance committees. The GTRL will be responsible for creating the medicine vision, early asset strategy and managing multiple external partnerships that accelerate delivery of the project. The GTRL will establish smart, fast, and critical path minded practices for groups, including integrating new strategies and competitive industry ways of working. The GTRL will advise on the continuous infusion of new Research projects aligned to strategy to generate a sustainable Research Engine generating a steady flow of high-quality INDs every year. Accountabilities Lead and manage one or more ‘Top 10’ drug discovery projects, overseeing the entire drug discovery process from target identification to preclinical development. (Top 10 projects are well validated targets that are focused on strategically aligned modalities with substantial clinical and commercial potential) Responsible for the articulation and ownership of the project strategy, developed in partnership with internal stakeholders. Contribute to strategy for future portfolio investment, particularly within the Inflammation and Immunology area including advising on which projects should be Top 10 projects. Evaluate and prioritize potential drug candidates based on scientific, medical, and commercial considerations. Represent all core expertise for the project. Partner with Clinical and Translational teams to refine asset strategy. Ensure alignment to the therapeutic area strategy (i.e., Clinical Development). Understand and align with the commercial team for asset commercial value within the TA. Provide guidance and mentorship to global project team members, stimulating enterprise thinking and fostering their professional growth and development. Mentor future and more junior project leads and elevate drug discovery capability across Research. Collaborate with cross-functional teams and partners (e.g., DMPK, Pharmaceutical Sciences) within and outside Takeda to drive project delivery. Pipeline and enterprise impact through effective partnering with multiple internal and external collaborators. Provide strategic, process, and operational leadership for successful Top 10 Project delivery. Foster a culture of innovation and scientific excellence within the matrixed drug discovery team, promoting collaboration, knowledge sharing, and continuous learning. Become a world leading scientific expert in the projects you lead. Oversee the design and execution of experiments, data analysis, and interpretation to enable decision-making and optimize drug discovery efforts. Stay abreast of the latest advancements in drug discovery, emerging technologies, and industry trends, applying this knowledge to enhance drug discovery strategies. Build and maintain relationships with key stakeholders, including academic institutions, research organizations, and industry partners inclusive of serving on joint external governance committees across the globe. Represent Takeda externally for the Gastroenterology and Inflammation Drug Discovery Unit and play a key role in evaluating external opportunities, serving as an effective ambassador for Takeda’s global business development brand. Education & Competencies (Technical and Behavioral): PhD degree in a scientific discipline with 15 years experience , or MS with 21 years experience, or BS with 23 years experience Expected to have at least 10-12 years industry and relevant subject matter expertise within Immunology and Inflammation and at least 10-12 years global management experience, including working effectively with matrix teams. Extensive experience in leading drug discovery teams and managing drug discovery/development projects, preferably in a pharmaceutical or biotechnology setting covering gastroenterology and inflammation. Deep understanding of the drug discovery process, including target identification, hit-to-lead optimization, and preclinical development, anticipating, and removing roadblocks. Proven track record of leading numerous projects, ideally 5 projects, across discovery from target inception to Candidate Nomination or beyond. Played a major role in 3 INDs. Has delivered clinical development assets, must include experience with biologics and preferably across multiple modalities. Excellent and inclusive leadership with the ability to inspire and motivate diverse teams towards achieving ambitious goals. Reputation as a proactive, solutions-oriented leader who engages relevant expertise no matter where it resides. Strong business acumen and understanding of the pharmaceutical industry, including regulatory requirements and commercial considerations with relevant knowledge and expertise for specific modalities. Exceptional communication and presentation skills, with the ability to effectively communicate complex scientific concepts to diverse audiences. Proven ability to build and maintain collaborative relationships with internal and external stakeholders across a matrixed organization. Strong problem-solving and decision-making abilities, with a focus on data-driven decision making. Demonstrated success in building and managing strategic partnerships with academic institutions, research organizations, and industry collaborators. ADDITIONAL INFORMATION The position will be based in Cambridge, MA . This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $212,000.00 - $333,190.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes. We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. How you will contribute: Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements. Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes. Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities. Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions. Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics. Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale. Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings. Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact. Promote sustainable practices and scalability in site-level regulatory operations. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. 10 years of overall biopharmaceutical/device industry experience with 8 years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Strong practical experience with global HA requirements, beyond EU/US. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Applies directions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies given prioritization framework with limited support. Excellent written and oral communication skills required. Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Director, Statistics in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda’s mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders. The R&D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda’s R&D pipeline. Central to Takeda’s R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics & Quantitative Sciences, Programming, Patient Safety & Pharmacovigilance, and Strategic Operations The Statistics and Quantitative Sciences (SQS) department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. POSITION ACCOUNTABILITIES: Lead delivery for one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Create an internal cross functional and external with vendors sphere of influence in predictable delivery Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: Must have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials: PHD with ~ 5 years experience MS with ~ 8 years experience Technical Skills: Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics Scientific understanding of drug R&D to inform methodological input with product team or in a platform Strong communication skills and ability to translate effectively across functional lines Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs Enable the tactical execution of the SQS and DQS vision and mission Lead and be accountable for asset level strategies being implemented Demonstrate mentorship, matrix or direct management of small team of SQS colleagues Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D Create an internal and external sphere of influence in area of expertise This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. LI-JV2 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. Education & Competencies: Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will: Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Are a leader within the department and within R&D contributing to department and cross functional Takeda initiatives and influencing the field as applicable. Provide leadership/contributes as global regulatory lead (GRL) responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. How you will contribute: The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed in line with changing regulatory and business needs. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement, and communicating in a professional and timely manner. Proactively anticipates risks and develops solutions/scenario planning for identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of project(s). The Associate Director will lead all submission types. Serves as the primary FDA contact. Leads and manages FDA meetings. Responsible for demonstrating Takeda leadership behaviors. Manages junior staff as needed. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in departmental and cross-functional task-forces and initiatives. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Supports the lead regulatory reviewer in due diligence for licensing opportunities. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates solid, increasingly independent regulatory strategy skills, including an understanding of core regulatory concepts and their organizational and global implications. Proactively identifies regulatory issues and proposes creative, practical solutions and strategies, including risk mitigation. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Director, Statistics in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda’s mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders. The R&D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda’s R&D pipeline. Central to Takeda’s R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics & Quantitative Sciences, Programming, Patient Safety & Pharmacovigilance, and Strategic Operations The Statistics and Quantitative Sciences (SQS) department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. POSITION ACCOUNTABILITIES: Lead delivery for one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Create an internal cross functional and external with vendors sphere of influence in predictable delivery Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: Must have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials: PHD with ~ 5 years experience MS with ~ 8 years experience Technical Skills: Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics Scientific understanding of drug R&D to inform methodological input with product team or in a platform Strong communication skills and ability to translate effectively across functional lines Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs Enable the tactical execution of the SQS and DQS vision and mission Lead and be accountable for asset level strategies being implemented Demonstrate mentorship, matrix or direct management of small team of SQS colleagues Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D Create an internal and external sphere of influence in area of expertise This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. LI-JV2 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Director, Statistics in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda’s mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders. The R&D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda’s R&D pipeline. Central to Takeda’s R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics & Quantitative Sciences, Programming, Patient Safety & Pharmacovigilance, and Strategic Operations The Statistics and Quantitative Sciences (SQS) department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. POSITION ACCOUNTABILITIES: Lead delivery for one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Create an internal cross functional and external with vendors sphere of influence in predictable delivery Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: Must have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials: PHD with ~ 5 years experience MS with ~ 8 years experience Technical Skills: Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics Scientific understanding of drug R&D to inform methodological input with product team or in a platform Strong communication skills and ability to translate effectively across functional lines Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs Enable the tactical execution of the SQS and DQS vision and mission Lead and be accountable for asset level strategies being implemented Demonstrate mentorship, matrix or direct management of small team of SQS colleagues Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D Create an internal and external sphere of influence in area of expertise This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. LI-JV2 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Objective / Purpose: The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution of clinical studies by developing robust supplier contracts through commercial negotiations and resolving commercial and operational challenges. This role is responsible for ensuring a high level of fiscal discipline as well as enhancing cross-functional collaboration, and ensuring studies start on time, aligned to business requirements and Takeda standards and with the right commercial structures in place. Accountabilities: Responsible for the development and finalization of study level contracts and change orders in partnership with key functions and aligned with Master Service Agreements, to ensure predictable delivery, quality and alignment to Takeda’s requirements, values and policies. Lead ballparking, contracting and commercial management of complex clinical studies, understanding study requirements and translating into robust supplier contracts across a broad category of suppliers supporting R&D activities for assigned therapeutic areas and studies Apply appropriate commercial constructs, aligned to business requirements, to enable study start, even with evolving assumptions Utilize cost models and workbooks to validate contract pricing and budget assumptions for complex agreements and develop enhancements to improve validation capabilities Drive negotiations with CRO’s and suppliers to secure optimal terms for Takeda Manage contract amendments throughout the study lifecycle Support study teams in completing final reconciliation at study closeout Develop close collaborative working relationships with clinical operations and other key stakeholders to improve understanding and engagement Generate preliminary cost estimates to support Study Execution Teams (SET) in budget planning Collaborate with study teams to address commercial/contractual challenges, proactively identify potential issues, develop contingency plans and escalate to Clinical Partner Outsourcing/SPO leadership as necessary Escalate issues through the appropriate channels when local resolution is not achievable Drive operational support & issue resolution by supporting teams in addressing operational and performance-related supplier issues Ensure consistency between contractual agreement and operational implementation Serve as a SME and lead continuous improvement initiatives to enhance performance and efficiency, identify best practices through industry benchmarking. As a member of the CPO team, anticipate and identify external industry trends impacting Takeda’s operating/cost model Ensure compliance with all applicable internal policies and procedures, regulations, support inspection readiness of all regulated activities. Lead or participate in special projects and initiatives to support the business Education & Competencies (Technical and Behavioral): Bachelors degree required; advanced technical degree (e.g MBA) or certifications (e.g PMP, CPA) preferred 7 years of experience in the pharmaceutical industry or clinical research environment Experience supporting a complex organization and demonstrated ability to work across functions and regions Proven experience in clinical procurement, contract management, or supplier relationship management Strong knowledge of clinical trial processes and regulatory requirements Experience in contract negotiations, financial analysis and budget management. Familiarity with CRO and clinical outsourcing models, including financial and commercial constructs Sound understanding of GCP, ICH guidelines, and clinical trial regulations Strong strategic thinking and project management skills Excellent communicator with strong written and verbal presentation skills ADDITIONAL INFORMATION : The position will be based in Cambridge, MA . This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Objective / Purpose: The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution of clinical studies by developing robust supplier contracts through commercial negotiations and resolving commercial and operational challenges. This role is responsible for ensuring a high level of fiscal discipline as well as enhancing cross-functional collaboration, and ensuring studies start on time, aligned to business requirements and Takeda standards and with the right commercial structures in place. Accountabilities: Responsible for the development and finalization of study level contracts and change orders in partnership with key functions and aligned with Master Service Agreements, to ensure predictable delivery, quality and alignment to Takeda’s requirements, values and policies. Lead ballparking, contracting and commercial management of complex clinical studies, understanding study requirements and translating into robust supplier contracts across a broad category of suppliers supporting R&D activities for assigned therapeutic areas and studies Apply appropriate commercial constructs, aligned to business requirements, to enable study start, even with evolving assumptions Utilize cost models and workbooks to validate contract pricing and budget assumptions for complex agreements and develop enhancements to improve validation capabilities Drive negotiations with CRO’s and suppliers to secure optimal terms for Takeda Manage contract amendments throughout the study lifecycle Support study teams in completing final reconciliation at study closeout Develop close collaborative working relationships with clinical operations and other key stakeholders to improve understanding and engagement Generate preliminary cost estimates to support Study Execution Teams (SET) in budget planning Collaborate with study teams to address commercial/contractual challenges, proactively identify potential issues, develop contingency plans and escalate to Clinical Partner Outsourcing/SPO leadership as necessary Escalate issues through the appropriate channels when local resolution is not achievable Drive operational support & issue resolution by supporting teams in addressing operational and performance-related supplier issues Ensure consistency between contractual agreement and operational implementation Serve as a SME and lead continuous improvement initiatives to enhance performance and efficiency, identify best practices through industry benchmarking. As a member of the CPO team, anticipate and identify external industry trends impacting Takeda’s operating/cost model Ensure compliance with all applicable internal policies and procedures, regulations, support inspection readiness of all regulated activities. Lead or participate in special projects and initiatives to support the business Education & Competencies (Technical and Behavioral): Bachelors degree required; advanced technical degree (e.g MBA) or certifications (e.g PMP, CPA) preferred 7 years of experience in the pharmaceutical industry or clinical research environment Experience supporting a complex organization and demonstrated ability to work across functions and regions Proven experience in clinical procurement, contract management, or supplier relationship management Strong knowledge of clinical trial processes and regulatory requirements Experience in contract negotiations, financial analysis and budget management. Familiarity with CRO and clinical outsourcing models, including financial and commercial constructs Sound understanding of GCP, ICH guidelines, and clinical trial regulations Strong strategic thinking and project management skills Excellent communicator with strong written and verbal presentation skills ADDITIONAL INFORMATION : The position will be based in Cambridge, MA . This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

To learn more about this role, ___. JOB OVERVIEW As a Field Merchandiser, you'll have the opportunity to work independently to showcase your organization and time management skills, your ability to establish retailer relationships, while being the face of Hallmark. You will collaborate with local store teams to optimize product placement and maintain inventory levels as well as support fellow team members with seasonal resets and installations, when needed. On occasion you may have the opportunity to work with other products from other companies in the stores that you service. SALARY AND SCHEDULE DETAILS • Your starting hourly pay rate will be $15.00 to $17.50 depending on your skills and experience., • We provide paid training, delivered through live, hands-on instruction as well as virtual classroom training., • Hallmark part time employees are offered voluntary benefits that include medical, dental, vision etc. Eligible Employees receive annual pay increases. • This is a Part-Time position with a variable schedule during the work week., • Average weekly hours for this position are between 11-15 hours per week., • Availability the week before and after major holidays, which may include weekends is required. You'll perform service work in the Hallmark department of various retail stores such as grocery stores, drug stores, department stores, and mass retailers. The retail merchandiser position consists of three major components: • Day-to-day engagement: Utilizing a mobile device provided by Hallmark, you'll restock, organize, and monitor the inventory of Hallmark products within and outside the Hallmark department. The use of technology is critical in this role, for the day-to-day work as well as communication with your supervisor, reporting time, providing feedback, and answering surveys for required merchandising activities. Professional and courteous interaction with store employees, management, and customers is also vital for success in this role. You are responsible for the entire Hallmark product display at your assigned stores., • Holiday support: Hallmark's operations revolve around seasonal demand. Leading up to and following holidays such as Valentine's Day, Easter, Mother's Day, Father's Day, Halloween, Thanksgiving, and Christmas, you can expect additional days and extended hours during the work week. On occasions like Valentine's Day, Mother's Day, and Father's Day, you may be required to work on the actual holiday itself, which may include the weekend., • Department Resets: At times, you may be part of a team responsible for installations and various tasks like building and installing Hallmark fixtures, relocating card departments and products, as well as resetting card sections. Typically, you will be notified two weeks in advance for remodel assignments. This could include evenings or weekend. This is a physically demanding job that requires a high level of energy and a sense of urgency. You will be working on the selling floor as well as in back stockrooms. You must be able to consistently push, pull, lift, and carry cartons, merchandise, and display fixtures up to 30 pounds throughout the workday and up to 50 pounds on occasion. You will also be required to kneel, squat, walk, and stand throughout your workday, and you may be required to climb stairs and step ladders. BASIC QUALIFICATIONS • You're at least 18 years of age., • You're able to read, write and understand English., • You have the ability to grasp, pull, lift, and carry products up to 30 pounds frequently and 50 pounds occasionally., • Able to operate a digital hand-held device to open and read documents and interpret information., • You have access to a Wi-Fi network and the internet. Prior to applying, ___. Now's your chance to Make Your Mark-just follow the instructions below to apply. You must show how you meet the basic qualifications in a resume or document you upload, or by completing the work experience and education application fields. Accepted file types are DOCX and PDF. Part-time employees with a work schedule less than 30 hours have access to a variety of voluntary benefits through ___including dental, vision, critical illness, accident insurance, hospital indemnity and minimum essential coverage (preventive care). In compliance with the Immigration Reform and Control Act of 1986, Hallmark Cards, Inc. and its subsidiary companies will hire only individuals lawfully authorized to work in the United States. Hallmark does not generally provide sponsorship for employment. Employment by Hallmark is contingent upon the signing of the Employment Agreement, signing of an agreement to arbitrate in connection with the Hallmark Dispute Resolution Program, completing Form I-9 Employment Eligibility Verification, and successfully pass pre-employment (post offer) background check. Hallmark is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, age, pregnancy, national origin, physical or mental disability, genetics, sexual orientation, gender identity, veteran status, or any other legally-protected status. Principals only please. HALLMARK - Because Connecting With Each Other Has Never Been More Important For over 100 years, ___ has helped people connect and strengthen the relationships that matter most. Today, we're building the next century of connection- blending the warmth of in-store experiences with the ease of digital innovation. We're looking for empathetic learners, strategic thinkers, and enthusiastic visionaries from all backgrounds to help shape what's next. If you're ready to bring fresh ideas and energy, we'd love to have you on the team! At Hallmark, you'll feel welcomed from day one- whether you're remote, hybrid, or in-office. We'll tap into your strengths, offer leadership opportunities, and support your growth every step of the way. Our ___ is rooted in care and inclusion. We celebrate diverse perspectives and actively seek out new voices- like yours- to help us grow and evolve. Let's imagine the future of Hallmark together! Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the ___ notice from the Department of Labor.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: * With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. * Has a strong and deep foundational understanding of global RA CMC regulations and guidelines. Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions. * Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. * Successfully communicates and negotiates with Health Authorities – directly and indirectly. * Able to apply GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. * With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy * Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. * With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters. * Interacts directly with international Health Authorities on administrative procedural topics, as required. * Fosters constructive working relationships when interacting with internal and/or external colleagues. * Evaluates change proposals for global regulatory impact. * As a GRA CMC member, ensures regulatory compliance with HA regulations. Assures conformance with Takeda controlled procedures and GRA CMC best practices. * Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. * Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. * When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. * Supports and/ or leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. * Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target. * Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. * BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. * 10+ years of overall biopharmaceutical/device industry experience with 5+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered). * Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. * Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. * Analyze issues with attention to detail. * Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. * Able to deal with issues of critical importance with minimal supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management. * Understands who is responsible for different decisions and escalates as necessary. * Applies decisions taken by the company. * Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. * Intentionally promotes an inclusive culture. * Applies the given prioritization framework with limited support. * Excellent written and oral communication skills required. * Exercises good judgement in elevating and communicating actual or potential issues to line management. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance. Establish best practices and builds a strong regulatory community across Global Regulatory Affairs spanning device, combination product, quality, clinical, development and manufacturing interfaces. Serve as an influential leader internally and externally, shaping regulatory policy and cross-functional decision-making for devices and combination products across major regions (e.g., US, EU, UK, Japan, China). * Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances. * Partners with cross-functional leaders (Regulatory, Development, Clinical, Quality, Safety, Manufacturing, Supply Chain, Market Access, and Medical) to align evidence generation, usability/human factors, risk management, and value messaging to regulatory and access requirements for devices and combination products. * Ensures line management and key stakeholders are apprised of developments impacting regulatory success (e.g., design changes, nonconformances, clinical evidence, labeling/UDI, post-market signals). Anticipates risks and drives mitigation plans consistent with ISO 14971, design controls, and applicable global regulations. * Represents Global Regulatory Affairs in senior-level governance and in interactions with global regulators and notified bodies, including FDA (CDRH/CDER and Office of Combination Products), EMA/Competent Authorities under EU MDR, MHRA, PMDA, and other agencies as applicable. * Accountable for ensuring global submissions and lifecycle compliance for devices and combination products (e.g., IDE, 510(k), De Novo, PMA, CE marking under MDR, technical documentation, variations/changes, vigilance). Partners with regional leads, quality, and vendors to ensure compliant, inspection-ready processes and documentation. * Leads departmental and cross-functional initiatives to improve regulatory strategy, operational excellence, and quality systems interfaces (e.g., design controls, labeling governance, supplier controls, post-market surveillance, digital/connected device considerations). Influences without authority across R&D and Global Regulatory Affairs. * Provides regulatory strategy leadership for business development and due diligence activities, including assessment of device/combination product classification, regulatory pathways, technical evidence requirements, and lifecycle obligations. * Monitors and anticipates global regulatory trends impacting devices and combination products (e.g., MDR implementation, FDA guidance, standards such as ISO 13485/14971/IEC 62304, cybersecurity expectations), translating insights into proactive regulatory and evidence strategies. * Responsible for demonstrating Takeda leadership behaviors. * Advanced degree in a scientific, or engineering discipline (e.g., MS, PhD, PharmD) * 20+ years of industry experience with 10+ years in Regulatory Affairs and demonstrated leadership in medical devices and/or drug-device combination products. * Significant experience leading, reviewing, authoring, or managing regulatory submissions for devices and/or combination products (e.g., IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation), including major deficiency responses and negotiation of requirements. * Strong working knowledge of device and combination product development and regulatory requirements, including FDA (CDRH/CDER/OCP), EU MDR/IVDR, and post-market/vigilance obligations; experience with other regions a plus. * Understands and interprets complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to device/combination regulatory requirements and strategy. * Provides expert guidance on global device/combination regulatory strategy, including technical documentation/Design History File expectations, design controls, human factors/usability, biocompatibility, software and cybersecurity considerations (as applicable), and post-market lifecycle planning. * Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. * Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative * Solutions and strategies, including risk mitigation strategies. * Must work well with others and within global teams. * Able to bring working teams together for common objectives. * Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $238,000.00 - $374,000.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: * Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) as the GRA CMC Product Lead. Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug product or suite of products is preferred. * Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle. * Demonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines. * Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. * Strong analytical or process understanding that enables the development of robust and accurate submissions * Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. * Successfully communicates and negotiates with Health Authorities – directly and indirectly. * Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. * Acts as mentor / coach to other GRA CMC members. * Develops, executes and oversees the preparation of major global registrational submissions. * Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges * Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters. * Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required. * Fosters constructive working relationships when interacting with internal and/or external colleagues. * Providing strategic input into change control evaluation - as required. * As a GRA CMC member, ensures and / or enhances regulatory compliance. * Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. * Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. * When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. * Proactively identifies regulatory CMC risks, ensuring timely communication with line management. * Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. * Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations. * Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target. * Supports development of strategies, tools, and trainings to further the GRA CMC roadmap. * Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. * BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required. * 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA. * Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. * Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. * Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. * Analyze issues with attention to detail. * Ability to assess alternative approaches. * Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines * Able to deal with issues of critical importance with minimal oversight. * Exercises good judgment in elevating and communicating actual or potential issues to line management. * Applies direction taken by the company. * Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. * Intentionally promotes an inclusive culture. * Applies given prioritization framework with limited support. * Excellent written and oral communication skills required. * Exercises good judgement in elevating and communicating actual or potential issues to line management. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and lon

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project. * Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Possesses primary responsibility for dosage selection and generation of causality evidence. * Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives. * Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines. * Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications. POSITION ACCOUNTABILITIES: * Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams. * Be charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum. * Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK). * Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions. * Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions. * Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DSI and external partners. * Maintains a high standard for good clinical practice, compliance, and ethics. * Mentors junior staff to promote scientific excellence and individual achievement. * Participates as a member of Business Development due diligence, when requested. * Contributes to infrastructure initiatives and/ or cross-functional best practice initiatives. * Has scientific influence outside QCP and Takeda through presentations and publications and active contribution to scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: * Pharm D. or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD * MS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD Technical Skills: * Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies. * Formulates and executes clinical pharmacology plans including integration of MIDD principles. * Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. * Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across different regions (ICH, FDA, EMA and others). * Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making. * Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics. * Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy. This position is currently classified as " hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creat

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: • Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects., • Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements., • Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable., • Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: • The Associate Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible., • Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy., • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner., • Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions., • Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types., • Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs., • Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed., • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products., • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope., • Participates with influence in or leads departmental and cross-functional task-forces and initiatives., • Lead regulatory reviewer in due diligence for licensing opportunities., • Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable., • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner., • Responsible for demonstrating Takeda leadership behaviors. Education & Competencies: • Bachelor's Degree, scientific discipline strongly preferred, • Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred, • 6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory experience, • Preferred experience in reviewing, authoring, or managing components of regulatory submissions., • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus., • Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy., • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy., • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability., • Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies., • Must work well with others and within global teams., • Able to bring working teams together for common objectives., • Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Director, Clinical Data Standards based remotely reporting to the Vice President, Clinical Data Operations & Standards. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: • In collaboration with the Clinical Data Strategy & Operations Leaders, and TAU Leaders, and other functional area leadership to develop, establishes and drives strategy of Takeda's global data standards, processes and technologies across the clinical data continuum for quality of deliverables and global data interoperability., • Responsible for establishing and managing a Standards vendor to support Standards Management vision., • Responsible for end-to-end Standards Governance to ensure proper utilization, adherence to standards governance and processes, and the ongoing, thorough assessment of library enhancements and deviations., • Build relationships across the global Takeda organization and with vendor partners in support of the standards vision and implementation., • Participates with and influences at industry standards forums in support of Takeda's therapeutic areas., • Serves as a resource to support questions raised by regulatory agencies. ACCOUNTABILITIES: • Has advanced knowledge of all standard library components and metadata across data collection, analysis and reporting continuum., • Works with Clinical Data Strategy & Operations Leaders, TAU Leaders, and other functional area leadership to develop, and adhere to, Standards Management vision and overall metadata management strategy., • Leads cross-functional Standards initiatives internal or external to Takeda and helps to ensure coherence of standards initiatives across organization., • Provides strategic guidance toward execution of comprehensive data continuum to staff and vendors acting as project managers or leads on cross-functional initiatives., • Supervises staff and vendors developing standards library to ensure alignment to standards strategy., • Develops training strategy and ensures consistent training program for standards., • Provides senior oversight to vendor/CROs for utilization of Takeda standards., • Conducts ongoing review and development of metrics to assess standards utilization and development trends., • Oversees Standards Governance, managing deviations from standards content and processes., • Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, SCDM, EDC users group, SAS users group, Third Party Data Acquisition groups, etc., • Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Takeda organization., • Complies with all applicable regulatory expectations. EDUCATION AND EXPERIENCE: • BS/BA or MS in a life science or analytical area., • 12 years data management and/or database or statistical programming experience in pharmaceutical industry or health related field., • 8+ years of experience supporting clinical trials across all phases of development., • 5+ years of progressive management experience., • Proven track record for development and management of a standards library., • In-depth knowledge of data management systems and processes, analysis and reporting principles., • Good knowledge of statistical programming languages (e.g. SAS)., • Technical expertise (e.g. Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS., • Expertise in the requirements and technology required to support electronic data capture and electronic submissions., • Proven track record in identifying and implementing organization-wide initiatives, standards, and processes., • Proven track record in managing global, cross-functional standards and processes., • Knowledge of medical and statistical terminology. Comprehensive understanding of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc.), • Able to influence without authority., • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills., • Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo., • Pragmatic and willing to drive and support change., • Is comfortable with ambiguity ., • Support a culture of continual improvement and innovation; promote knowledge sharing. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $212,000.00 - $333,190.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #LI-Remote

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's ___ and ___. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Objective / Purpose: The Director, High-Throughput In Vitro ADME is a senior scientific and operational leader responsible for building and directing Takeda's high-throughput in vitro ADME capabilities in support of small- and large-molecule discovery programs. Reporting to the Head of Drug Discovery Lab Automation and Transformation, this Director will define strategy, oversee operations, and drive technology innovation at the interface of ADME science, laboratory automation, and robotics. The organization will operate as a service-oriented group, delivering robust, high-quality ADME data to enable rapid, high-confidence decision-making in Design–Make–Test–Analyze (DMTA) cycles across the portfolio. Accountabilities: • Strategic Leadership & Vision, • Define and execute the multi-year strategic roadmap for high-throughput in vitro ADME at Takeda, aligned with the broader vision of the Drug Discovery Lab Automation and Transformation organization., • Shape an enterprise-level, service-oriented operating model for ADME, ensuring capacity, capability, and flexibility to meet evolving project and portfolio needs., • Champion innovation in high throughput assay design, detection technologies, automation, and data workflows to enhance throughput, quality, and cost-effectiveness., • Team Leadership & People Development, • Lead, mentor, and grow a team of scientists and research associates responsible for the routine delivery of a comprehensive suite of in vitro ADME assays., • Build a culture of scientific rigor, operational excellence, safety, and customer focus, supported by clear KPIs (e.g., cycle time, success rate, capacity utilization, cost-per-data point)., • Drive talent development and performance management appropriate for a Director-level organization., • High-Throughput ADME Operations, • Oversee design, execution, and continuous improvement of a broad high throughout in vitro ADME panel, including but not limited to:, • Metabolic stability and clearance (microsomes, hepatocytes, S9), • CYP inhibition and induction, • Permeability (e.g., Caco-2, MDCK, PAMPA), • Plasma protein and tissue binding, • Transporter and other mechanistic assays, • Ensure robust support for both small-molecule and large-molecule modalities, adapting methods for new modalities and platforms as the portfolio evolves., • Own and maintain fit-for-purpose validation, QC, and SOP frameworks, including root-cause analysis and corrective actions for assay or system deviations., • Laboratory Automation, Robotics & Miniaturization, • Provide scientific and strategic leadership for laboratory automation and robotics within the in vitro ADME space, in close alignment with the Head of Drug Discovery Lab Automation and Transformation., • Lead assay miniaturization up to 1536-well formats, from feasibility and optimization through technology transfer into robust, routine operation., • Oversee integration of liquid handlers, plate handlers, robotic arms, incubators, readers, and scheduling software into end-to-end automated workflows., • Partner with internal automation/engineering and informatics teams to ensure seamless connectivity between instruments, LIMS/ELN, data pipelines, and analytical platforms., • Cross-Functional Collaboration, • Serve as the primary ADME service leader interfacing with DMPK, medicinal chemistry, biology, pharmacology, translational sciences, and data science., • Translate portfolio and project needs into clear ADME assay strategies, capacity plans, and timelines; communicate priorities, risks, and trade-offs with transparency at project and governance levels., • Collaborate with external CROs, technology vendors, and academic partners when appropriate, ensuring consistent quality standards and strategic alignment with internal capabilities., • Quality, Compliance & Continuous Improvement, • Ensure scientific quality, data integrity, and safety in all ADME operations, consistent with Takeda policies and relevant regulatory expectations., • Define and monitor KPIs for throughput, on-time delivery, reproducibility, and cost; apply data-driven methodologies (e.g., Lean, Six Sigma, DoE) to drive continuous improvement., • Oversee investigations and CAPA implementation related to assay performance, automation reliability, or data issues., • Education and Experience:, • Expected: Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field with 10+ years of relevant industry experience; or M.S. with 16+ years; or B.S. with 18+ years in pharmaceutical/biotech R&D., • Extensive expertise in in vitro ADME, including method development, validation, and deployment across core assay types., • Direct experience in an organization providing ADME services (e.g., CRO or internal ADME service group), with a strong service- and customer-oriented mindset., • Proven leadership experience at the Director level, managing scientific teams and complex operations in a high-throughput environment., • Demonstrated strategic and hands-on experience with laboratory automation and robotics, including selection, implementation, and lifecycle managemet., • Successful track record in miniaturizing ADME assays formats, including optimization for data quality, robustness, and throughput., • Experience supporting both small- and large-molecule discovery programs., • Familiarity with LIMS/ELN, instrument integration, and data analysis/visualization tools in a high-throughput setting. Proven track record of: • Building or transforming high throughput ADME capabilities (e.g. establishing new platforms, scaling capacity, modernizing legacy workflows., • Understanding how ADME outputs integrate with DMPK, PK/PD and translational strategies and inform decision making, • Experience with data science and process optimization approaches to support advanced analytics, and continuous improvement ADDITIONAL INFORMATION * The position will be based in Cambridge, MA This position is currently classified as "hybrid" by Takeda's Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for