Japan jobs in Cambridge, MassachusettsCreate job alerts

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:Reporting directly to the Corporate Development and Strategy Manager, the Corporate Development Transactions Intern will gain hands-on experience in biopharmaceutical corporate development and the steps involved in executing strategic transactions. The intern will learn to use market intelligence and financial databases to interpret large datasets, analyze the financials and strategies of potential targets, and develop recommendations that inform future corporate development activities. This role will also support ad hoc projects, providing exposure to business, finance, and scientific analysis in a biopharma setting.Key Responsibilities: • Analyze pharmaceutical and biotechnology companies, including financial performance, pipeline, portfolio fit, and strategic positioning., • Learn and utilize market intelligence and financial databases to source and evaluate potential transaction targets., • Interpret and synthesize large datasets into concise, actionable insights for the corporate development team., • Prepare clear, well-structured presentations and summaries outlining company profiles, key findings, and recommended next steps., • Support corporate development team members on ad hoc analyses related to screening, sourcing, and transaction assessment., • Track and organize research, assumptions, and outputs to ensure work is reproducible and easy to reference.Desired Outcomes:, • Development of structured, repeatable approaches for analyzing biopharmaceutical companies using market and financial databases., • Presentation materials (e.g., slide decks, written summaries) that provide recommendations on potential targets and next steps for the corporate development team., • Direct support to screening and sourcing activities that contributes to the early-stage evaluation of future transactions.Qualifications:, • Currently pursuing a degree in Finance, Business, Economics, Life Sciences, or a related field with strong quantitative and analytical components., • Strong analytical and problem-solving skills with the ability to work with and interpret large datasets., • Interest in biopharmaceuticals, corporate strategy, and transactions (M&A, partnerships, licensing)., • Proficiency with Excel and PowerPoint, and comfort learning new data and research tools., • Strong written and verbal communication skills with attention to detail and structure.What You Will Gain:, • Practical experience in biopharmaceutical corporate development, from screening to early-stage evaluation of potential transactions., • Skills in using market and financial databases to analyze companies and industries., • Exposure to how business, finance, and scientific considerations come together in strategic decision-making., • Concrete work products (analyses and presentations) that demonstrate your ability to support corporate development activities.Work Environment:, • Hybrid position with 3 days in office in Waltham, MA.The hourly rate for this Internship position is $25/hour. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.Ardelyx is an equal opportunity employer.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:The Audit & Monitoring Dashboard Intern will support the transformation of how the Audit & Monitoring team tracks, analyzes, and reports audit findings and monitoring observations. The department currently relies on spreadsheets and documents, which makes trend analysis and reporting timeconsuming. In this internship, you will design and build a centralized, visual reporting tool in Tableau to help the team identify recurring issues, track remediation efforts, and provide leadership with a clear, datadriven view of the compliance landscape.Key Responsibilities: • Design, develop, and maintain Tableau dashboards to centralize audit and monitoring data., • Consolidate information from spreadsheets and documents into a structured, analysisready format., • Create visualizations that highlight trends, recurring issues, and key compliance risk areas., • Build reports and views that help track remediation activities and their status over time., • Partner with Audit & Monitoring team members to understand reporting needs and translate them into dashboard requirements., • Validate data accuracy and ensure dashboards are reliable, userfriendly, and easy to interpret., • Tableau dashboards that provide realtime insight into audit findings and monitoring observations., • Clear visibility into compliance trends, recurring issues, and remediation progress., • Currently pursuing a degree in Data Analytics, Information Systems, Computer Science, Business Analytics, or a related field., • Experience building dashboards in Tableau (coursework, projects, or prior internships)., • Strong analytical and problemsolving skills with a high attention to detail., • Comfort working with data in spreadsheets and other structured formats., • Ability to translate business questions into metrics, reports, and visualizations., • Strong communication skills and willingness to collaborate with nontechnical stakeholders.Preferred Skills:, • Familiarity with basic data modeling, data cleaning, or ETL concepts., • Experience with Excel, SQL, or other data tools is a plus., • Interest in audit, compliance, or risk management. What You Will Gain: • Handson experience building productiongrade Tableau dashboards in a corporate environment., • Exposure to audit and compliance processes and how data supports decisionmaking., • Experience collaborating with crossfunctional stakeholders and presenting insights to leadership., • A portfolioready project demonstrating your ability to turn raw data into actionable insights.The hourly rate for this Internship position is $25/hour. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.Ardelyx is an equal opportunity employer.

Location Woburn, MA Regular travel within the U.S. and occasional trips to HQ in France About BALYO BALYO is a global leader in Mobile Robotics. Our mission is to design, sell, and operate scalable, simple, and affordable robotic solutions worldwide. From our startup roots, we’ve grown into an international automation player while keeping our fast-paced, entrepreneurial mindset. BALYO is listed on Euronext Paris. Since November 2023, SoftBank has acquired over 90% of the company, making BALYO part of a global robotics ecosystem of more than 180 employees. We operate globally with headquarters in Paris and offices in the U.S., Singapore, Japan, and Australia, delivering robotic solutions across nearly every market worldwide. The role As Facility & Administrative Manager, you will be the go-to person for our U.S. operations. You play a central role in ensuring that our offices run smoothly, efficiently, and safely, while supporting teams across Finance, HR, IT, Sales, and more. This is a hands-on, transversal role for someone who enjoys wearing multiple hats: organizing, improving processes, solving problems, and making everyday work easier for others. From facilities and vendors to admin workflows and internal coordination, you’ll keep things moving, even when challenges pop up at the last minute. Your duties will be primarily performed in our Massachusetts office, unless otherwise agreed. The role requires travel within the U.S. and occasional trips to our headquarters in France. Administrative & Cross-Functional Support • Support Finance & Accounting in Purchase-to-Pay processes and internal controls (expense approvals, purchase orders, cost optimization, dispute resolution with vendors), • Assist HQ Finance with monthly reconciliation of U.S. corporate credit cards, • Act as administrator for all U.S. business travel via the company travel platform (Perk), • Coordinate company-wide and team events, meetings, and logistics, • Support internal communications (emails, signage, office communications, event materials), • Assist HR & IT with onboarding/offboarding, policies, and internal systems, • Serve as a key point of contact for Head Office departments (Finance, Marketing, Sales, etc.) for U.S.-related topics Operations & Process Improvement • Streamline administrative and operational workflows to improve efficiency, • Track and monitor actual vs. budgeted costs for U.S. office expenses (supplies, shipping, consumables, etc.), • Foster strong cross-department collaboration and clear internal communication Profile & qualifications • Bachelor’s degree or at least 3 years of experience in office management, facilities management, or operations, • Solid understanding of accounting and administrative processes, • Highly organized, detail-oriented, and able to multitask and prioritize effectively, • Strong interpersonal and communication skills, with a collaborative mindset, • Comfortable with Microsoft Office and Google Workspace; eager to learn new tools and systems, • Experience with budget tracking, vendor management, procurement, and event logistics, • Self-starter with a proactive, solution-oriented attitude and a genuine “how can I help?” mindset, • Takes pride in keeping workspaces organized, welcoming, and functional, • Acts as an ambassador of company culture and promotes a positive work environment, • French is a plus Why join BALYO? • A key, visible role with real impact on day-to-day operations, • An international, fast-growing tech environment backed by SoftBank, • A collaborative culture that values ownership, initiative, and continuous improvement, • The opportunity to grow alongside a global robotics leader BALYO is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:The Medical Affairs Intern will evaluate the potential role and value of social media within Ardelyx Medical Affairs, with a primary focus on platforms such as LinkedIn and X (Twitter). The intern will conduct competitive intelligence and benchmarking on how peer biotechnology and pharmaceutical companies use social media to disseminate scientific information, publications, and congress updates, and will assess Ardelyx's current Medical Affairs social media activities to generate structured, evidencebased recommendations for leadership.Key Responsibilities: • Conduct competitive intelligence, • Review Medical Affairsrelevant social media activity across a defined list of biotechnology and pharmaceutical companies., • Identify how Medical Affairs teams use platforms such as LinkedIn and X to share scientific information, publications, and congress updates., • Document examples of common approaches to publication dissemination, congress coverage, and medical content sharing., • Assess current Ardelyx Medical social media activities, • Review the current Ardelyx Medical Affairs social media program, including vendorsupported publication and abstract posts., • Evaluate existing engagement metrics, posting cadence, and content mix., • Identify the types of scientific information currently shared through Ardelyx Medical channels and how they are positioned., • Benchmark industry practices, • Compare Ardelyx Medical's current approach with observed practices from peer companies., • Identify common strategies, governance models, and engagement patterns used across the industry., • Evaluate whether and how social media appears to support scientific communication or visibility for Medical Affairs organizations., • Gather internal context, • Meet with select Medical Affairs team members to understand how social media currently supports publications, congress activity, and scientific communications., • Focus discussions on clarifying current practices, objectives, and constraints rather than designing new workflows., • Evaluate platforms and potential opportunities, • Explore whether additional or emerging professional platforms are being used by peer companies for Medical Affairs engagement., • Identify potential areas where the Ardelyx Medical social media program could be optimized, simplified, or refocused., • Develop findings and recommendations, • Synthesize research into a structured summary of findings, including competitive intelligence, benchmarks, and key observations., • Outline potential paths forward (e.g., maintain the current approach, optimize the current model, expand selectively, or discontinue if strategic value appears limited)., • Prepare and deliver a short presentation summarizing findings and recommendations to Medical Affairs leadership., • Additional Medical Affairs Operations support, • As time allows, assist with shortterm Medical Affairs Operations projects or analyses aligned with the intern's skills and development goals.Desired Outcomes:, • A clear, evidencebased overview of how Medical Affairs organizations use social media and how Ardelyx's current approach compares to peers., • Actionable insights and options that inform leadership discussions about the future role of social media within Ardelyx Medical Affairs, including best practices and considerations for any potential optimization or evolution of the program., • A concise presentation and supporting documentation that Medical Affairs leadership can reference when evaluating next steps after the internship concludes. Qualifications: • Currently pursuing a degree in Life Sciences, Public Health, Pharmacy, Health Communications, Marketing, or a related field., • Strong analytical and research skills, with the ability to synthesize information from multiple sources., • Interest in Medical Affairs, scientific communication, and digital/social media in a biopharmaceutical context., • Strong written and verbal communication skills and ability to summarize complex information clearly., • Organized, detailoriented, and comfortable working with qualitative and basic quantitative data (e.g., engagement metrics).Preferred Skills:, • Familiarity with LinkedIn and X (Twitter) as professional/scientific communication channels., • Prior experience in social media analysis, competitive intelligence, or communications is a plus., • Basic presentation skills and proficiency in PowerPoint or similar tools.What You Will Gain:, • Handson experience at the intersection of Medical Affairs, digital engagement, and competitive intelligence., • Exposure to how biopharmaceutical companies use social media to support scientific communications and Medical Affairs objectives., • Experience benchmarking industry practices and developing evidencebased recommendations for senior stakeholders., • A tangible work product (analysis, recommendations, and presentation) demonstrating your ability to evaluate digital strategies within a Medical Affairs setting.Work Environment:, • Location ideally in or close to Waltham, MA.The hourly rate for this Internship position is $25/hour. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.Ardelyx is an equal opportunity employer.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: The Senior Medical Science Liaison (Senior MSL) serves as a field-based advanced technical, scientific, and medical expert, answers product-related questions from HCPs, and provides clinical/scientific presentations and medical education programs. The Senior MSL is responsible for developing, coordinating, and assuring implementation of Ardelyx's corporate, scientific, and clinical strategies with Key Opinion Leaders (KOLs) within academic, clinical, and healthcare organizations. These scientific exchanges will support and/or expand current therapeutic concepts, as well as ensure the safe and effective utilization of Ardelyx's assets. The Senior MSL builds upon the foundational responsibilities of the MSL by providing advanced scientific engagement, deeper strategic input, and informal leadership across the Field Medical Affairs function. The Senior MSL is recognized as a subject matter expert, mentor to peers, and key contributor to national field medical initiatives as required, playing an important role in aligning field insights with broader medical strategy. Responsibilities: • Serve as the primary field-based medical liaison in providing medical information and scientific exchange to external/internal stakeholders, • Identify, establish, and manage collaborative relationships with local, national, and regional medical/scientific leaders/investigators to identify and address scientific needs, • Present healthcare professionals and decision makers with accurate, unbiased, balanced, and timely answers to unsolicited requests for information in the therapeutic field responsible, • Establish scientific and clinical relationships with thought leaders and academic/community centers to expand research and educational opportunities, • Engage in non-product discussions regarding scientific topics (e.g., disease state, diagnosis, epidemiology, unmet medical need, population health, etc.), • Prioritize and work effectively in a self-directed manner in a constantly changing environment, including ability to obtain, integrate and communicate HCP feedback, • Participate in advisory boards and other company meetings, • Attend key medical and scientific congresses and conferences (local, regional and national) as needed, • Lead department-wide projects and participate in cross-functional activities that serve strategic initiatives, • Provide strategic insights by maintaining expertise in the therapeutic area and related fields to effectively communicate scientific insights and support strategic objectives, • Monitor the competitive environment for advances and trends in the therapeutic area, including new treatment management and therapies, competitive products and provide feedback to internal stakeholders on specific initiatives of competitors, • Serves as peer leader to mentor and coach new or junior MSLs, supporting onboarding, training, and field excellenceQualifications:, • Doctorate degree (PharmD, PhD, MD, DNP, etc) in biological sciences with 5+ years of MSL Medical Affairs expertise within the therapeutic area or equivalent experience, • Advanced Medical/Scientific masters degree (NP, PA) with combined extensive clinical expertise will be considered, • Ability to apply technical expertise and solutions to diverse/individualized situations, • Critical data analysis skills, • Excellent communication & presentation skills, • Networking skills and the confidence to interact with senior experts on a peer-to-peer level, • Demonstrated ability to integrate and work in cross functional network/matrix, • Prior experience in mentorship of medical science liaisons, • Demonstrated project management ability, • Knowledge of FDA and OIG requirements, as well as the PhRMA Code, including regulations governing compliant scientific exchange, • Ability to travel locally, regionally, and nationally as requested/required; up to 70% travel, • Valid driver's licenseThe anticipated annualized base pay range for this full-time position is $185,000-$232,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:We are seeking an experienced and highly strategic Director, Access Marketing to join our dynamic team. This individual will serve as a key business partner to support and drive various corporate, brand, and market access initiatives. This role will lead the development and execution of payer and access marketing strategies and tactics aimed at securing, maintaining, and optimizing product access across B2B customers, including payers, dialysis organizations (DO) and other stakeholders in the United States healthcare ecosystems.Responsibilities: • Lead the development and implementation of B2B access marketing tactics and pull-through resources. This may include materials for teams calling on payers, dialysis organizations, or health care providers (for reimbursement needs), • Develop account-specific tactical recommendations based on customer type, business needs, and competitive landscape, ensuring timely and profitable access, • Partner within Market Access & Patient services and other cross-functional commercial partners, including: brand leadership, commercial operations, and HEOR, medical, Regulatory, Patient Services, Finance, Trade, Account Management to ensure alignment of payer marketing strategies with overall business objectives, • Lead strategic alignment and execution with National and Regional Market Access account teams on tactical plans aligned with organizational and brand strategies, • Identify and execute marketing needs for field access managers, including reimbursement marketing materials that support access and pull-through objectives, • Implement key tactics for various payer channels (e.g., government, commercial), • Partner with Data Analytics to deliver market insights that inform payer strategies, tactics, and promotional plans, • Partner with Data, Analytics, and Operations to execute market research needs and gaps (e.g., Advisory Boards), • Act as the Market Access point of contact on cross-functional brand teams, fostering collaboration and ensuring strong market access representation, • Represent Market Access in Medical, Legal, and Regulatory (LMR) review meetings, • Manage the payer marketing budget, agency of record, and external vendors as necessaryQualifications:, • Bachelor's degree in marketing, business, or a related field, MBA preferred, with 9 - 12 years of experience or relevant experience, particularly in the pharmaceutical or biopharma industry or equivalent experience, • In-depth understanding of payer and reimbursement market dynamics, including commercialization, pricing, reimbursement, and access, • Proven ability to develop and execute pull-through plans specific to payers, • Strong project management skills, with the ability to drive projects independently, establish budgets, and meet deadlines, • Exceptional interpersonal skills, with a focus on relationship-building through transparency and trust, • Ability to collaborate, influence, and work with a wide range of internal and external stakeholders to achieve results, • Experience managing multiple priorities and meeting deadlines under business constraints, • Strong communication skills with the ability to craft and deliver compelling narratives, • Proven success in working collaboratively across the business to design and execute solutions to complex challenges preferred

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Reporting directly to the Vice President of Corporate Development and Strategy, the Director of Alliance Management will manage and optimize strategic collaborations with global pharmaceutical and biotech partners.The ideal candidate has hands-on experience managing complex, multi-functional alliances, proactively resolving issues, and driving structured decision-making that leads to clear outcomes.Note: this position will be based out of Waltham, MA and would require relocation to Massachusetts.Responsibilities:Alliance Leadership & Governance: • Serve as the primary alliance lead for strategic partnerships, owning day-to-day relationship management, • Design, implement, and run alliance governance structures (JSCs, sub-teams, escalation pathways), • Ensure decisions are made efficiently, documented clearly, and executed across both organizationsIssue Resolution & Decision Enablement:, • Anticipate and surface alliance risks (operational, strategic, financial, contractual), • Lead cross-functional problem-solving efforts to address issues that arise, • Drive discussions that result in timely decisions and measurable outcomesCross-Functional Execution:, • Coordinate closely with R&D, Tech Ops, Commercial, Legal, Finance, and BD teams, • Support operational execution of alliance agreements and ensure adherence to contractual obligations, • Track milestones, deliverables, and performance metricsPartner Relationship Management:, • Build trusted, senior-level relationships with partner counterparts, • Balance collaboration and accountability, advocating for Ardelyx's interests while maintaining strong partnerships, • Prepare and lead executive-level communications and governance meetingsStrategic & Portfolio Support:, • Provide alliance insights to inform broader corporate strategy and portfolio decisions, • Support business development during deal structuring and diligence to ensure alliances are operationally sound post-signing, • Contribute to best practices, playbooks, and continuous improvement of alliance management processesQualifications:, • Bachelor's degree with 8-10 years of experience in alliance management, business development, corporate development, or related roles in biotech/pharma or equivalent experience, • Proven track record managing complex, high-stakes alliances with external partners, • Demonstrated ability to drive processes that lead to decisions and results, especially in ambiguous or contentious situations that require escalation, renegotiation, or restructuring, • Strong understanding of alliance governance, contract interpretation, and cross-functional execution, • Exceptional communication, influence, and stakeholder-management skillsThe anticipated annualized base pay range for this full-time position is $210,000 - $256,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.Ardelyx is an equal opportunity employer.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:The Associate Director, Stability is a self-motivated individual who works as a member of an integrated team at Ardelyx contracting, designing, managing, and evaluating stability studies at contractors for both drug substance and drug product. This individual should have the breadth of experience required to manage stability studies in early stage as well as in commercial stage. This individual should have a good knowledge of ICH and cGMP guidelines and the ability to contribute to regulatory filings as needed for stability.Please note: this position is hybrid-based out of our Waltham, MA or Newark, CA office and requires a presence on-site 2-3 days per week.Responsibilities: • Develop and implement the strategic direction of stability programs aligned with corporate goals and product life-cycle objectives, • Oversee the design, execution, and management of stability studies (development, registration, and commercial), • Work cross functionally with CMC, supply chain, quality, regulatory, clinical and related teams to achieve stability objectives, • Contract with and manage manufacturing and analytical contractors conducting stability studies including supporting finance in forecasting and expense tracking, • Coordinate and facilitate the movement of material to stability contractors from manufacturing sites as needed, • Initiate and drive stability protocol generation and other quality documents in support of stability studies, • Compile stability study results, perform trend and statistical analyses, and prepare reports to support retest/shelf-life date extensions and storage condition recommendations, • Partner with quality during stability quality events (QEs) or investigations and implementation of CAPAs at contractors, • Author CMC stability documentation for IND, NDA and IMPD filings, covering all phases of clinical development and commercial activities, • Represent the stability function and present work at intra/inter departmental meetingsQualifications:, • B.S. degree in a scientific field, such as chemistry or biology, with 10+ years' experience working in the pharmaceutical industry or equivalent experience, • Excellent working knowledge of small molecule analytical chemistry with prior experience as an analytical scientist desirable, • Flexible and adaptive team player with excellent verbal and written communication skills, • Exceptional organizational skills and meticulous attention to detail, • Extensive experience with small molecule drug product and drug substance stability programs, • Experience managing contractor stability activities, • Extensive experience with ICH and FDA guidelines, • Experience in authoring regulatory submissions (IND, NDA, MAA) and associated reports, • Ability to travel up to 5% domestically or internationallyThe anticipated annualized base pay range for this full-time position is $169,000-$207,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.Ardelyx is an equal opportunity employer.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:The Internal Communications & Digital Content Intern will support key initiatives that strengthen Ardelyx's internal and digital communications, with a primary focus on enhancing the company intranet. This role will assist with managing the editorial calendar, drafting and publishing intranet content, and collaborating with stakeholders across the organization. The intern will also play an important role in developing an intranetbased Learning Hub for employees. Additional responsibilities include supporting internal events, corporate giving activities - such as the company's annual Giving Week - and contributing to digital and social content creation. Key Responsibilities: • Intranet content & calendar management, • Maintain the intranet content calendar, ensuring timely updates, tracking deliverables, and coordinating with stakeholders., • Draft, edit, and publish intranet content including articles, posts, spotlights, updates, and crossfunctional announcements., • Collaborate with stakeholders to update content, gather new materials, and maintain consistent tone, branding, and structure across the platform., • Learning Hub development & launch support, • Help build intranet-based Learning Hub, including both static educational content and concepts for live learning opportunities., • Meet with subjectmatter experts to gather information and translate complex topics into clear, accessible materials., • Shape the structure, layout, and user experience of the Learning Hub and work toward its golive plan (pages, launch content, supporting materials)., • Corporate Giving & Giving Week support, • Support the Corporate Giving Program and Giving Week planning by researching nonprofit partners and engagement opportunities., • Draft internal communications, digital and print materials, and assist with early coordination and logistics for Giving Week., • Digital and social content support, • Contribute to digital and social content development aligned with the Ardelyx brand voice., • Conduct trend research to inform content ideas and ensure relevance across channels., • Draft brandaligned copy and graphics to support broader corporate communications initiatives.Desired Outcomes:, • Successful contribution to the launch and content buildout of intranet-based Learning Hub, including static educational materials and live learning concepts., • Strengthened intranet engagement through timely, highquality content and wellcoordinated updates across the platform., • Improved readiness for Giving Week with foundational materials, plans, and content drafted in advance., • Enhanced digital and internal communication assets that support consistent, engaging storytelling across the organization.Qualifications:, • Currently pursuing a degree in Communications, Marketing, Journalism, Public Relations, Digital Media, or a related field., • Strong writing and editing skills with the ability to adapt tone and style to align with brand voice., • Interest in internal communications, digital content, and corporate social responsibility., • Strong organizational and project management skills; able to juggle multiple deadlines and stakeholders., • Comfort collaborating with cross functional partners and interviewing subject matter experts., • Excel; ability to present complex ideas in clear, structured formats., • Strong communication and collaboration skills, comfortable engaging with cross-functional stakeholders.Preferred Skills:, • Experience with intranet platforms, content management systems, or basic web publishing is a plus., • Familiarity with social media platforms and digital content best practices., • Basic design sensibility or experience with simple design tools (e.g., Canva, PowerPoint) helpful but not required.What You Will Gain:, • Handson experience in internal communications, digital content creation, and corporate social responsibility within a biotech environment., • Direct involvement in launching a strategic intranet resource (Learning Hub) from concept to golive planning., • Exposure to crossfunctional collaboration and stakeholder management across departments., • A portfolio of writing samples and project work demonstrating impact on intranet, digital communications, and Giving Week preparation.Work Environment:, • Location ideally in or close to Waltham, MA.The hourly rate for this Internship position is $25 per hour. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.Ardelyx is an equal opportunity employer.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:The Clinical Research Associate (CRA) supports sponsor oversight of clinical trial execution with an focus on site performance, data quality, and regulatory compliance. Building on prior experience in a Clinical Trial Assistant (CTA) or similar role, the CRA II independently manages assigned sites and supports study oversight of clinical trial execution.This role partners closely with Clinical Trial Managers, Field CRAs, vendors, and cross-functional stakeholders to ensure trials are conducted in accordance with ICH-GCP, applicable regulations, and internal governance standards. The CRA II contributes to proactive risk identification, issue resolution and continuous inspection readiness.Responsibilities: • Provide sponsor oversight of assigned investigative sites, serving as the primary operational and ensuring high - quality protocol execution, and compliance with GCP, and regulatory requirements, • Monitor site performance through centralized and remote review of study data, key performance metrics, and monitoring outputs, including proactively identify and escalate issues with recommended mitigation strategies, • Support study start-up, conduct, and close-out activities, including site feasibility, activation, training, and close-out documentation, • Ensure timely collection, review, and maintenance of essential regulatory documents and maintain Trial Master File (TMF) completeness, quality and inspection readiness, • Partner with Clinical Trial Managers and CRO monitoring teams to provide sponsor oversight and ensure monitoring activities align with the study's risk-based monitoring strategy, • Track and analyze protocol deviations, safety events, data discrepancies, and site performance trends; collaborate with cross-functional teams to drive timely resolution, • Support regulatory and inspection readiness by overseeing IRB/EC submissions and approvals, maintaining accurate site documentation, and contributing to audit and inspection preparation, responses, and follow-up activities, • Collaborate cross-functionally with Clinical Operations, Data Management, Safety, Regulatory Affairs, and Biostatistics, and support sponsor oversight of CROs and other, • Participate in investigator meetings, study team meetings, and internal governance as requiredQualifications:, • Bachelor's degree in relevant scientific discipline with 2-5 years of experience in clinical research, clinical operations or healthcare-related roles or equivalent combination of education and experience, • Prior experience as a Clinical Trial Assistant (CTA), Study Coordinator, or similar clinical research role required, • Working knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements, • Experience with sponsor systems EDC, eTMF, CTMS and centralized monitoring tools, • Strong analytical skills with the ability to interpret study and site-level performance trends, • Excellent written and verbal communication skills with high level of attention to detail, • Demonstrated sponsor mindset with a focus on quality, accountability, and compliance, • Ability to work independently while escalating issues appropriately, • Strong problem abilities and proactive risk identification skills, • Effective collaboration and stakeholder management abilities, • Thrives in a collaborative environment and enjoys working cross-functionally to solve operational challenges., • Ability to travel as neededThe anticipated annualized base pay range for this full-time position is $99,000 - $121,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.Ardelyx is an equal opportunity employer.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:The Vice President, Analytical Development & Quality Control (AD/QC), is the enterprise leader accountable for Ardelex's analytical chemistry activities. Reporting to the Chief Technical Operations Officer, the VP of AD/QC will provide oversight of Ardelyx's array of contract testing laboratories across the company's portfolio of development-stage projects and commercial products. The VP of AD/QC will build, improve, and scale a modern, inspection ready analytical chemistry capability that ensures reliable supply, strengthens compliance, and champions a proactive, high-engagement technical and quality culture across internal teams and external partners.Responsibilities: • Provide strategic direction and vision for the AD/QC department, aligning it with the overall company objectives and regulatory requirements, • Partner with other functions (e.g. Supply Chain, CMC, Quality Assurance, and Regulatory Affairs) to develop and implement appropriate control strategies for all stages of product development and manufacturing, • Lead and collaborate with other departments to implement quality and process improvement initiatives, • Oversee the development, validation, implementation, and life-cycle management of analytical methods for the analysis of raw materials, intermediates, drug substance, and drug product, • Ensure that all AD/QC activities are conducted in stage-appropriate accordance with current Good Manufacturing Practices (cGMPs) and relevant regulatory requirements, • Author and review IND/NDA Module 3 sections, with primary responsibility for Characterization/Impurities, Analytical Methods/Validation, Batch Analysis, Specifications, and Stability, • Manage and develop a team of skilled professionals, providing mentorship and fostering a culture of excellence, innovation, collaboration, and teamwork, • Develop and maintain productive relationships with outsourced analytical testing partners, actively managing all associated activities, • Allocate internal and external resources effectively to meet departmental and corporate timelines and objectives, • Develop and monitor Key Performance Indicators (KPIs) for the AD/QC department, • Collaborate with QA in the preparation and presentation of reports to management on quality-related metrics and compliance statusQualifications:, • An advanced degree (MS or Ph.D.) in Chemistry or a related discipline, • 15+ years pharmaceutical industry experience, with a strong background in the AD and QC functions, phase-appropriate requirements, and at least 10 years of experience in a managerial role, or equivalent experience, • Proven track record of successful collaboration with key stakeholder functions (e.g. Supply Chain, CMC, Quality Assurance, and Regulatory Affairs), • In-depth knowledge of current regulatory requirements and guidelines for analytical development and quality control (cGMP, ICH, FDA, etc.), • Direct experience as a lead author of relevant Module 3 sections and supporting regulatory authority inspections, • Experience with computerized systems (e.g. LIMS, Veeva, etc.) and their associated compliance requirements, • Strong technical problem-solving and decision-making skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organizationWork Environment:, • The position is based in our Waltham, MA office and requires onsite presence 2-3 days per week., • The ability to travel to Ardelyx's other locations and external testing labs is required (up to 20 %)The anticipated annualized base pay range for this full-time position is $302,000 - $370,000 Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:The Director, R&D Quality Management provides leadership for the company's GCP, GLP, and GVP audit and vendor management programs, ensuring a risk-based approach that strengthens oversight and anticipates emerging quality risks. The role is responsible for GCP, GLP, GVP inspection readiness and drives modernization of quality processes and technology. Working cross-functionally, the Director monitors regulatory changes, and leverages quality analytics to inform decision-making and long-range planning. Through proactive quality-risk monitoring and cross-functional collaboration, the Director enables strong, data-driven decision making and fosters a culture of continuous improvement.Responsibilities: • Design and implement a risk-based GCP, GLP, GVP audit strategy that strengthens organizational oversight, anticipates quality risks, and aligns with long-term business development priorities, • Oversee and manage the on-time execution of all audit types (vendor/supplier, clinical investigator site, internal process), including management of contract auditors, corrective action process, and collaboration with internal GxP functions, • Establish proactive quality risk monitoring and mitigation frameworks, leveraging audit outcomes, CAPA trends, and cross-functional signals to drive strategic decisions and enable a culture of continuous improvement, • Define a comprehensive vendor compliance strategy, ensuring external partners are aligned with the company's quality standards, risk posture, and long-term operational objectives, • Identify and drive opportunities for modernizing quality processes, digital tools, and ways of working and advance nimble, risk-based, data-driven quality operations, • Drive an inspection readiness program that equips the organization to quickly mobilize and effectively engage with global health authorities, including serving in key inspection roles supporting the functional team during inspections, • Partner with clinical development to embed RBQM principles and technologies into operational models, ensuring quality is built into development strategies from design to execution, • Provide quality support and guidance to functional teams, including providing training on relevant quality topics, • Develop, review, and approve procedural documents ensuring they reflect current regulatory expectations, operational realities, and a risk-based approach to quality, • Oversee the use of quality data to identify GCP, GLP, GVP quality trends, inform Quality Management Review, and influence strategic planning across R&D and QA, • Monitor changes in the regulatory landscape and assess their implications for the business to drive modern quality and compliance strategies, • Manage and/or coach internal staff and consultants, cultivating a team capable of advancing modern quality practices and delivering high-quality, on-time results, • Bachelor's degree in scientific, legal, or other applicable discipline, with 10+ years in the pharmaceutical industry, with exposure to multiple regulated areas, or equivalent experience, • Direct experience auditing and overseeing GCP compliance, • Experience in GLP and/or GVP quality is strongly desired, • Knowledge of GCP compliance activities necessary for clinical trial management and study site management, • Demonstrated experience in leading, managing and improving pharmaceutical quality systems, • Experience with RBQM and Quality by design, • Experience working with and overseeing external service providers, • Hands-on experience participating in regulatory inspections, • Demonstrated experience in managing pharmaceutical quality systems such as Management Review, Document Management, Training, Deviation/Investigation, CAPA, and Quality Metrics reporting, • General understanding of pharmaceutical research and development; ability to partner with the business functions to enable high quality outcomes, • Experience using Veeva Quality Management systems is strongly desired, • Strong leadership, technical, management, problem solving and project management skills, • Good presentation, verbal and written communication skillsThe anticipated annualized base pay range for this full-time position is $205,000-$250,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.Ardelyx is an equal opportunity employer.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:The Clinical Trial Manager (CTM) is responsible for the end-to-end operational oversight of clinical trials, from study planning through close-out and reporting. This role ensures trials are executed ethically, on time, within budget, and in full compliance with applicable regulatory requirements and Good Clinical Practice (GCP), while maintaining the highest standards of patient safety and data integrity.Responsibilities: • Provide operational leadership for one or more clinical studies or programs, overseeing execution from initial study synopsis through final deliverables, including study start-up, enrollment, conduct, database lock, statistical outputs (TLFs), and Clinical Study Report (CSR), • Lead study start-up activities in collaboration with CROs and investigational sites, including oversight of clinical document development and site activation activities, • Manage day-to-day study execution, ensuring adherence to timelines, milestones, budgets and quality standards, • Contribute to and review study plans, timelines, and operational deliverables; proactively identify risks and implement mitigation strategies to ensure successful study outcomes, • Prepare, review and/approve study-related documents including but not limited toInformed Consent Forms, CRFs, Monitoring Plans, Laboratory Manuals, Patient Diaries, Clinical Site Procedures Manual and CRF Completion Guidelines), • Implement risk management and mitigation strategies, prioritizing tasks and issues to ensure successful program/study objectives, • Participate in and support user acceptance testing (UAT) for clinical systems, (e.g., EDC IRT), including contribution to system requirements and validation activities, • Oversee vendor performance and relationships including CROs, central laboratories, and contribute to or lead the systems set-up/management, EDC/IRT, and specialty services (ePRO, ECG, imaging etc.), • Ensure compliance with GCP, applicable regulations, SOPs, and study-specific procedures throughout the trial lifecycle, • Track, analyze and communicate study progress, risks and key metrics to the Study Lead and senior management, including development and maintenance dashboards and trackers, • Represent Clinical Operations professionally, fostering productive relationships with investigators, CRO partners, vendors and internal cross functional teamsQualifications:, • Bachelor's degree in Life Sciences, Nursing, or a related field with 5+ years of experience in clinical trial management or related clinical research roles; equivalent experience may be considered, • Master's degree and clinical research certification (e.g., CCRA, CCRP) strongly preferred, • Demonstrated knowledge of current clinical trial processes, GCP, ICH guidelines and regulatory requirements, • Strong project management skills, including managing of timelines, budgets, and cross-functional resources, • Excellent written and verbal communication with the ability to lead cross-functional teams and external partners., • Proven problem-solving skills and tools, and ability to manage complex operational issues in a fast paced environment, • Experience with clinical trial systems and tools including EDC, IRT and Veeva Vault platforms,), • Ability to travel occasionally to clinical sites, investigator meetings, and professional conferences as required, • Remote work considered; preference for candidates able to attend the office weekly (Newark or Waltham)The anticipated annualized base pay range for this full-time position is $136,000-$160,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.Ardelyx is an equal opportunity employer.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: We are seeking an Associate Director of Nonclinical Development to join our experienced R&D team supporting drug development programs. The Associate Director will design and implement nonclinical strategies to evaluate and advance Ardelyx's drug candidates through different stages of development. This position involves designing and managing GLP safety studies at contract research organizations (CROs) for early and late-stage programs, analyzing and interpreting safety data, and collaborating with cross-functional teams. Responsibilities: • Oversee the conduct of nonclinical studies to support Ardelyx programs, including non-GLP and GLP toxicology, pharmacology, and DMPK studies, • Identify/qualify new or existing CROs, • Serve as the Nonclinical representative during GLP audits, • Author and review SOPs and policies related to the Nonclinical function, • Oversee study logistics, including managing contracts with vendors, tracking invoices and payments, and procuring/shipping study materials, • Conduct study monitoring visits, • Review and evaluate study protocols, data, and reports, • Author and review regulatory documents including IND, NDA/BLA, IB, and DSUR, • Prepare and present study updates to internal project teams and senior managementQualifications:, • PhD or advanced degree in toxicology, pharmacology, biology, or related scientific discipline with 7+ years of relevant work experience in the pharmaceutical industry or equivalent experience, • In-depth knowledge and technical oversight of nonclinical toxicology, pharmacology, and DMPK studies, • Experience conducting or overseeing nonclinical studies with small and large molecules is preferred, • Extensive knowledge of GLP principles and FDA/ICH guidelines, • Ability to analyze/interpret complex data and troubleshoot, • Highly organized with excellent written and oral communication skills, • Experience as a supervisor is a plus, • Ability to work effectively with cross-functional R&D colleaguesThe anticipated annualized base pay range for this full-time position is $205,000 - $251,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Clinical Science, Solid Tumor in our Cambridge office. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Deve

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Clinical Science, Solid Tumor in our Cambridge office. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Deve

Our Boston area biotech client is seeking an experienced Clinical Research Associate (CRA) to support pre‑randomization review activities across global study sites. This role focuses on verifying seizure count calculations and ensuring appropriate source documentation is in place in alignment with protocol requirements and GCP. The position is designed to provide timely, targeted review and site engagement without mandating specific source tools or workflows. Work Model • On‑call, as‑needed support aligned to enrollment timelines, • Regionally aligned (e.g., US, EU, Japan) to ensure time zone responsiveness, • Conduct targeted review of seizure count calculations prior to patient randomization, • Engage directly with site staff to clarify documentation concerns and request additional supporting information when needed, • Provide clear, timely feedback to the study team and escalate issues appropriately, • 5+ years of CRA experience in clinical trials (neurology or epilepsy experience preferred), • Strong understanding of GCP, source documentation standards, and eligibility verification processes, • Experience with remote monitoring and/or centralized review models, • Demonstrated ability to work independently and manage rapid‑turnaround requests, • Excellent communication skills and experience engaging investigational sites, • Ability to assess data quality and documentation completeness with sound clinical judgment

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 DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Clinical Science, Solid Tumor in our Cambridge 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.OBJECTIVES: The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences TGRD and TPC senior leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products.ACCOUNTABILITIES: Clinical Development team participation and leadership Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy. Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and commercial viability of a product.Synopsis / Protocol Development, Study Execution, & Study Interpretation Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy.Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.Trial Medical Monitoring Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.Makes final decisions regarding study conduct related to scientific integrity.External Interactions Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives.Due Diligence, Business Development and Alliance Projects Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.Leadership, Task Force Participation, Upper Management Accountability Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross-functional teams, as appropriate.Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Education/ ExperienceMD, combined MD/PhD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).Training and Experience in Hematology/ Oncology and/or Medical Oncology especially in solid tumor malignancies is preferredExperience in conducting and/or leading clinical trials involving immune-based therapies and/or antibody-drug conjugates is preferred.Late phase clinical development and NDA/MAA/Submission experience is preferred.Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.Management experienceSkillsExcellent communication and influencing skills, with the ability to engage, inspire, and influence stakeholders at all levels, including executive management and external partners.Ability to proactively predict issues and solve problemsAbility to drive decision-making within a multi-disciplinary, multi-regional, matrix teamsDiplomacy and positive influencing abilitiesKnowledgeTherapeutic area knowledge relevant to mechanism of actionRegional/global Regulatory requirementsGCP/ICHEmerging research in designated therapeutic areaTRAVEL REQUIREMENTS:Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.Requires approximately 15 - 25% travel.Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regar

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. 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. #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: $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 ]]> <

Cabot Properties is a leading international private equity real estate investment firm specializing in logistics and industrial properties. With a strategic focus on high-growth, global gateway markets, we invest in, develop, and operate modern distribution facilities that power global commerce. For almost 40 years, we have delivered value on behalf of our institutional investors through disciplined investment strategies and deep expertise. Our global footprint spans the United States, United Kingdom, Western Europe, and Australia, and Japan, where we have built a strong reputation as a trusted partner in the logistics real estate sector. To date, Cabot has invested over $18 billion in logistics real estate, managing a portfolio of more than 1,750 properties encompassing 245 million square feet and serving over 4,300 tenants. Our scale, experience, and commitment to operational excellence position us as a long-term industry leader in one of the most dynamic segments of commercial real estate. Job Summary The Senior Portfolio Accountant plays a critical role in overseeing the accounting, financial reporting, and compliance requirements for Cabot's private real estate funds and separate accounts. This individual will ensure timely and accurate preparation of financial statements in accordance with U.S. GAAP, review internal and third-party property reporting, and support audits, cash forecasting, and investor reporting. The ideal candidate will bring strong technical accounting skills, excellent attention to detail, and the ability to manage multiple priorities in a fast-paced, collaborative environment. Financial Reporting & Analysis • Prepare and review quarterly and annual financial statements for Cabot's funds and separate accounts in accordance with U.S. GAAP., • Review property-level financials results prepared by internal and third-party managers to ensure accuracy and consistency with Cabot's accounting policies., • Analyze fund and portfolio level results, identifying and explaining key variances., • Assist with the preparation of monthly and quarterly cash forecasts for assigned funds or accounts., • Monitor and record capital activity, distributions, and investment transactions., • Coordinate with internal teams to ensure timely and accurate processing of invoices, accruals, and expense allocations., • Support annual audits, liaising with external auditors to provide requested documentation and resolve inquiries., • Ensure compliance with internal controls, accounting standards, and company policies., • Partner with Portfolio Management, Asset Management, and Investor Relations to support financial analysis and reporting needs., • Coordinate with internal and external accounting teams to ensure consistency and completeness of financial information., • Bachelor's degree in Accounting required; CPA or progress toward CPA preferred., • 4-6 years of experience in real estate, fund, or client accounting., • Prior experience preparing consolidated financial statements and supporting audits., • Proficiency with Microsoft Office Suite (Excel, PowerPoint, Word, Outlook)., • Experience with property or fund accounting systems such as MRI, Yardi, or similar platforms strongly preferred., • Strong analytical and problem-solving skills, with attention to detail and accuracy., • Excellent interpersonal and communication skills, with the ability to work effectively across departments., • Hybrid work model based primarily in a professional office environment., • Ability to remain in a stationary position (e.g., seated at a desk) for extended periods., • Frequent use of computers and digital communication platforms., • Occasional domestic travel may be required for meetings, audits, or internal company events. Cabot Properties is an equal opportunity employer committed to creating an inclusive and respectful workplace for all. We provide equal employment opportunities to all individuals regardless of race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic information, pregnancy, marital or civil partnership status, veteran status, or any other characteristic protected by applicable laws. We believe that diversity, equity, and inclusion are essential to our success, and we strive to foster a culture where every team member feels valued, respected, and empowered to contribute fully. MA Pay Range$110,000—$125,000 USD

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.Position Summary:The Corporate Development & Strategy Intern will support search and evaluation activities for new business development and licensing (BD&L) opportunities. The team has built a database of potential assets across multiple therapeutic areas and modalities, and this role will focus on conducting a deep dive within a single therapeutic area. The intern will identify assets that meet predefined strategic and scientific parameters and prepare concise overviews for the deal team to review. Key Responsibilities: • Review and analyze a curated database of Preclinical through Phase 2 ready assets within a selected therapeutic area (s)., • Apply predefined strategic, clinical, and scientific criteria to identify assets that fit the company's BD&L parameters., • Conduct secondary research using proprietary and public data sources (e.g., scientific literature, competitive intelligence, clinical trial databases)., • Develop one-page "tear sheets" summarizing each prioritized asset, including MOA, relevance in disease, and available preclinical and/or clinical data., • Synthesize complex scientific and market landscape information into clear, structured summaries for the deal team., • Collaborate with the manager to refine filters, prioritization criteria, and asset short lists based on interim findings.Desired Outcomes:, • Initial asset list for the chosen therapeutic area, followed by a refined subset based on parameters aligned with the manager., • A short PowerPoint deck providing a high-level overview of the therapeutic area and prioritized assets., • A set of one-page tear sheets on a subset of assets (final number to be determined) that the deal team can quickly react to and use to guide BD&L discussions.Qualifications:, • Currently pursuing a degree in Life Sciences (e.g., Biology, Pharmacology, Biochemistry), Biomedical Engineering, Pharmacy, Business with a strong scientific focus, or a related field., • Strong scientific foundation and ability to understand mechanisms of action, disease biology, and clinical data at a high level., • Excellent analytical and critical-thinking skills, with the ability to evaluate and compare assets against structured criteria., • Proficiency with PowerPoint and comfort summarizing complex information in concise, visual formats., • Strong written and verbal communication skills with attention to detail and organization.Preferred Skills:, • Familiarity with drug development, clinical trial phases, and basic regulatory concepts., • Experience conducting literature reviews or working with scientific/clinical databases., • Interest in corporate development, BD&L, or life sciences strategy. What You Will Gain: • Hands-on exposure to search and evaluation in a corporate development & strategy setting., • Experience applying a scientific background to real-world problem solving and portfolio decision-making., • Broader understanding of different disease areas, modalities, and how potential assets may translate into patient benefit., • A tangible work product (tear sheets and overview deck) that demonstrates your ability to bridge science, strategy, and business.Work Environment:, • Location ideally in or close to Waltham, MA.The hourly rate for this Internship position is $25/hour. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.Ardelyx is an equal opportunity employer.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Clinical Science, Solid Tumor in our Cambridge office. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Deve

Many nurses find the joy of serving others to be incredibly rewarding. This is especially true in the Navy Nurse Corps. When you work to improve the lives of others, you can vastly improve your own as well - both professionally and personally. As a Navy Nurse, you will serve your country by helping not only those in the military, but also their families and people in need around the globe. Excellent scholarship opportunities mean you have the potential to graduate from nursing school debt-free, and specialty training opportunities can give you a competitive edge in your field. Want to start your journey with the Navy? Apply Now Officer None Navy Nurse Corps: What to Expect Nurse Corps Officer Anesthesiology More Information About Navy Nursing Responsibilities As an Officer in the Nurse Corps, you'll provide high-quality nursing care wherever there's a need, from Navy medical facilities and ships to humanitarian aid missions overseas. You'll work closely with other health providers to carry out job responsibilities such as: • Providing general nursing care for Sailors, Marines, other service members and their families at the best military nursing facilities on shore, at sea and in the field, • Collaborating with Physicians, Surgeons, Cardiologists and other specialists to create and administer treatment plans, • Directing and instructing Hospital Corpsmen on how to provide quality patient care, • Applying leading-edge medical advances at world-class hospitals, • Utilizing some of the most advanced technology on the planet, such as Radio Frequency Identification (RFID), which can lead to less paperwork and more meaningful patient care, • Assisting with global relief efforts such as distributing vaccines or providing emergency care to victims of natural disastersWork Environment Nurse Corps Officers may serve at any one of more than 250 Navy and medical facilities around the globe, from Hawaii to Japan, Germany to Guam, and Washington, D.C., to Washington state. As a Navy Nurse, you may work at one of the highly acclaimed National Naval Medical Centers in Bethesda, MD, Portsmouth, VA, or San Diego, CA. You might even provide medical support aboard one of two dedicated hospital ships-the USNS Comfort and USNS Mercy. Additional opportunities are available on surface ships, with aircraft squadrons, or even with the Fleet Marine Force. Training & Advancement Upon commissioning, Nurses who are new to the Navy are required to attend Officer Development School (ODS) in Newport, RI. ODS is a five-week program designed to introduce you to Navy culture. Nurses commissioned through a school ROTC program may not need to attend ODS. Officer training is complete, you will learn the ins and outs of life as a Navy Nurse before receiving your first posting. Promotion opportunities are regularly available but competitive and based on performance. The Navy provides Nurse Corps Officers the opportunity to specialize based on manning needs. Specialization fields include: Nurse Anesthetists • Administer general and regional anesthesia, monitor patients receiving anesthesia, and assist in instructing medical trainees and other OfficersPrimary Care Nurse Practitioners, • Provide comprehensive health care and health maintenance for service members and their familiesMedical-Surgical Nurses, • Assess, plan and implement direct nursing care of patients on an assigned unit, and assume charge nurse responsibilitiesPerioperative Nurses, • Plan, implement and evaluate nursing care of surgery patientsCritical Care Nurses, • Provide highly skilled, specialized nursing care to critical patients, including en route care, and train personnel in critical care nursing proceduresMental Health Nurses and Nurse Practitioners - Provide direct patient care in mental health services, and lead and train other military and civilian personnel Military-specific Specializations • Education and training, manpower systems analysis, and nursing researchPost-Service Opportunities Specialized training received and work experience gained in the course of service can lead to valuable credentialing and occupational opportunities in the medical field. Education Opportunities Wherever you are in your nursing career, the Navy can help ease your financial burdens and advance your career with generous financial assistance and continuing education programs. Available offers consist of scholarships, sign-on bonuses and loan repayment assistance. Help can be available if you're in graduate school or already in practice as well. For High School Students: Through a Naval Reserve Officers Training Corps (NROTC) Nurse Option scholarship, the Navy can cover the full cost - up to $180,000 - of your nursing education at some of the best colleges and universities in the country. For Nursing Students: If you're a nursing student opting to serve full-time in the Navy, you may get up to $34,000 to help pay your way through nursing school through the Nurse Candidate Program (NCP). For Graduate Students: If you're a graduate student enrolled in a postgraduate nursing program in certain nursing specialties and opting to serve part-time in the Navy Reserve, you may qualify for up to $50,000 in nursing school loan repayment assistance. For Practicing Nurses: If you're a practicing nurse opting to serve part-time in the Navy Reserve, you may qualify for an immediate, one-time sign-on bonus of up to $30,000. Depending on your specialty, you may have the option of choosing between a sign-on bonus, nursing school loan repayment assistance or specialty pay. To learn what you qualify to receive, request a medical recruiter contact you. Qualifications & Requirements A degree from a four-year college or university is a minimum educational requirement to become a Commissioned Officer. You must also attend Officer Training. There may be exceptions to the degree requirements based on extensive service experience. Additional qualifications include: • U.S. Citizen between the ages of 18 and 41, • Currently licensed and practicing nursing in the U.S. (new graduates must obtain a license within one year of beginning Active Duty service), • In good standing (as a student or graduate) with a CCNE-accredited U.S. education program granting a Bachelor of Science degree, • Willing to serve a minimum of three years Active Duty When serving part-time as a Navy Reserve Nurse, your duties are carried out during your scheduled drilling and training periods. During monthly drilling, Nurse Corps Officers in the Navy Reserve typically work at a location close to their homes. For annual training, you may serve anywhere in the world, including locations in the U.S., at bases overseas, or in areas where humanitarian needs are great. Take a moment to learn more about the general roles and responsibilities of Navy Reserve Sailors. Most of what you do in the Navy Reserve is considered training. The basic Navy Reserve commitment involves training a minimum of one weekend a month (referred to as drilling) and two weeks a year (referred to as Annual Training) - or the equivalent of that. Nurses in the Navy Reserve serve in an Officer role. Before receiving the ongoing professional training that comes with this job, initial training requirements must first be met. For current or former Navy Officers (NAVET): Prior experience satisfies the initial leadership training requirement - so you will not need to go through Officer Training again. For current or former Officers of military branches other than the Navy (OSVET), as well as for Officer candidates without prior military experience: Officer Candidates are required to attend Officer Development School (ODS) in Newport, RI. ODS is a five-week program that provides a comprehensive and intense introduction to the responsibilities of Navy Staff Corps Officers. Officers who previously held a commission in another United States Military Service, National Oceanic and Atmospheric Administration, Public Health Service, or United States Coast Guard are exempt from attending ODS or LDO/CWO Academy. With flexible training options, Nurses in the Navy Reserve can comfortably balance civilian and military schedules. Additionally, professional nurses who choose to serve as Reserve Sailors in the Navy Nurse Corps may qualify for special offers. Depending on your specialty, you may qualify for an accession bonus or specialty pay. Compare Navy Careers See how a career as a Navy Nurse compares to other Navy jobs. Compare roles, pay and requirements for each job now.

SO OTHERS MAY LIVE When disaster strikes, Aviation Rescue Swimmers don't hesitate-they jump. Into raging seas, hurricane winds, and combat zones, they go where others won't- to bring people back alive. As part of the world's most elite Special Operations force, Navy AIRRs execute life-or-death rescues in the most extreme conditions. Whether pulling survivors from sinking ships, saving downed pilots, or braving towering waves, they live by one mission: so others may live. That motto isn't just a phrase-it's a promise. And they prove it every time they leap into the unknown. Enlisted None WATCH VIDEOS ABOUT AIRR Aviation Rescue Swimmer Naval Aircrewman Helicopter - Sierra Naval Aircrewman Helicopter - Romeo Naval Aircrewman: MH-60 Romeo & MH-60 Sierra AVIATION RESCUE SWIMMER: CAREER DETAILS & REQUIREMENTS Responsibilities Aviation Rescue Swimmers are tasked with entering treacherous conditions to assist with rescue missions, humanitarian assistance, and operational support. One day you may be evacuating families on the other side of the globe amidst a catastrophic storm, and the next day rescuing the crew of a ship off the Pacific coast or saving a mountain climber hanging from an inaccessible cliff. Depending on your role, duties may include: • Coordinating with pilots as an Aircrewman aboard helicopters, • Saving the crew of downed aircraft, people aboard stranded or capsized vessels at sea, or hikers and mountain climbers in danger, • Rescuing civilians during natural disasters in collaboration with other forces such as the Coast Guard, • Delivering aid and supplies to other countries in humanitarian operations, • Providing support to Naval Special Warfare Operations, • Conducting surveillance in anti-submarine warfare and drug interdiction operations, • Operate radar, Forward Looking Infrared sensors, missile systems and door guns in anti-surface operations AWS's operate various aircraft systems to support a range of mission types including: • Surface Warfare, • Search and Rescue, • Combat Search and Rescue, • Naval Special Warfare, • Airborne Mine Countermeasure, • LogisticsNaval Aircrewman Tactical Helicopter (AWR) AWR's operate various aircraft systems to support a range of mission types including: • Anti-Submarine, • Recon & Intelligence, • Anti-Surface Ship, • Search and Rescue, • Combat Search and Rescue, • Naval Special Warfare Fire SupportWork Environment As an AIRR, you will operate in almost every type of extreme environment and may be assigned to Helicopter Sea Combat (HSC) or Helicopter Maritime Strike Squadrons (HSM) sea or shore duty in any part of the world. You could be assigned to squadrons at Naval Air Stations and may deploy aboard aircraft carriers, surface combat ships and support ships. Training & Advancement Aviation Rescue Swimmers must be prepared to operate in any challenging environment. It's why two years of training in advanced swimming and lifesaving techniques, helicopter mission equipment and helicopter weapons systems are required before you report to your first squadron. Throughout training, candidates are continually tested mentally and physically as they advance to more rigorous and challenging scenarios. Upon completion of initial training at Recruit Training Command Great Lakes (known as Boot Camp), those pursuing an Aircrewman role undergo the following training pipeline: Aviation Rescue Swimmer School Prep Course (2 weeks) in Pensacola, FL. Aircrew Candidate School (4 weeks) in Pensacola, FL, to learn Naval Aviation fundamentals, intermediate water survival, aviation physiology and advanced water survival. Rescue Swimmer School (6 weeks) in Pensacola, FL, to learn search and rescue techniques. Class "A" Technical School (8-14 weeks) in Pensacola, FL, learning one of the Aircrew Ratings (AWF, AWO, AWS, AWR, AWV). SERE School (2 weeks) in North Island, CA, or Portsmouth, NH, to train in Survival, Evasion, Resistance and Escape (SERE) techniques. Fleet Replacement Squadrons (28-52 weeks) location dependent on aircrew rating in one of five locations (Jacksonville, FL, Norfolk, VA, San Diego, CA, Oklahoma City, OK, Ft Worth, TX) for basic flight and aircraft weapons systems training. After graduation, an AIRR may be assigned to a helicopter command at sea or on shore duty in various locations throughout the world, Japan, Guam, Spain, or the continental US including San Diego, CA, Norfolk, VA, Jacksonville, FL, Fallon, NV, Whidbey Island, WA, Key West, FL and many others. Advanced Education & Training Based on performance and the needs of the Navy, you could potentially be eligible to receive additional training in: • Emergency Medical Technician (EMT) training, • Helicopter Inland Rappel School (mountain & cliff rescue training), • Advanced Search and Rescue School Senior enlisted AIRRs may also be selected to become:, • Schoolhouse instructors, • Weapons instructors, • Master rappelers/instructorsPost-Service Opportunities Specialized training received and work experience gained in the course of service can lead to valuable credentialing and occupational opportunities in related fields in the civilian world whether you're an AWS or AWR. Education Opportunities Members of the Naval Special Warfare community have any number of unique opportunities to advance their knowledge. Navy training provides skills and knowledge in everything from military tactics and small arms use to survival and a number of other tactical military procedures. Beyond offering access to professional credentials and certifications, Navy training in this field can translate to credit hours toward a bachelor's or associate degree through the American Council on Education. You may also continue your education through undergraduate degree opportunities like the Navy College Program and Tuition Assistance and the Post-9/11 GI Bill. Qualifications & Requirements No college degree is required to become an AIRR, but a high degree of difficulty comes standard with nearly everything you'll do. Training is tough and ongoing. You should be in excellent physical condition and a strong swimmer. To qualify for Rescue Swimmer Training, both men and women must: • Meet specific eyesight requirements: uncorrected vision no worse than 20/100; correctable to 20/20 in both eyes with normal depth and color perception, • Meet the minimum Armed Services Vocational Aptitude Battery (ASVAB) score: VE+AR+MK+MC=210 or VE+AR+MK+AS=210, • Pass a PST in DEP/Boot Camp, • Pass Class 1 Flight Physical, • Be 30 years of age or younger NOTE: You should consult your physician or other health-care professional before starting any exercise regime or other fitness program to determine if it is right for your needs. This is particularly true if you (or your family) have a history of medical illnesses or ailments that could be made worse by a change in physical activity. Do not start a fitness program if your physician or health-care provider advises against it. General qualifications may vary depending upon whether you're currently serving, whether you've served before or whether you've never served before. Part-Time Opportunities There are no part-time jobs as a Navy Reserve Sailor in this role. Go back to Careers to find other jobs that have a Reserve component. You can also find out more about what life is like as a Reserve Sailor in the Navy. Aviation Rescue Swimmer - PST Full HTML CAN YOU OUTPERFORM TOP AIRR CANDIDATES? Check the AIRR PST leaderboard and find a testing event near you. Learn More Compare Navy Careers See how a career as a First Responder Careers compares to other Navy jobs. Compare roles, pay and requirements for each job now.

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. 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. #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: $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 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. Purpose * Leveraging a proven track record of leading at least 3 discovery programs to clinic, The Global Therapeutic Research Lead (G-TRL) is a pipeline critical strategic leader responsible for driving Research projects to the clinic. The individual will sit on the Neuroscience Drug Discovery Unit (NS DDU) Leadership Team. * Leader for at least one or more of Takeda’s top priority small molecule 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 G-TRL builds a connected view of the project within the Neuroscience 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. * G-TRLs are responsible for creating the medicine vision, early asset strategy and managing multiple external partnerships that accelerate delivery of the project. * G-TRLs will establish smart, fast, and critical path minded practices for groups, including integrating new strategies and competitive industry ways of working. * G-TRL 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 molecule 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 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 commercial team for asset commercial value within the Neuroscience Therapeutic Area (NS 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 Neuroscience 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): * Advanced degree in health or life sciences (e.g., Ph.D., M.D., D.V.M.) * 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 in small molecules and have insight into oligonucleotide and biologic 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. * As part of our global R&D strategy, and unique to the Research organization’s strong lab presence in Shonan, Japan, this role may include the opportunity for a temporary or long-term international assignment in Japan, subject to business needs and final candidate selection. Candidates interested in global exposure are encouraged to apply. 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: $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 <

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. The Associate Director (Source-to-Applications) will lead the solution, design, and delivery of the company's Source-to-Pay (S2P) technology ecosystem, encompassing Coupa, SAP as ERP, and related integration layers . This role is responsible for ensuring seamless process alignment between Procurement, Finance, and Supply Chain , optimizing technology investments, and enabling digital transformation through automation and data-driven insights. The ideal candidate combines deep functional knowledge of procurement and finance processes with strong technical experience in Coupa, SAP, integrations, and governance . Job Duties and Responsibilities Leadership * Serve as the IT solution lead for Coupa, SAP MM/FI CO, and other related procurement and finance systems. * Partner with Procurement, Finance, and IT leadership to drive process optimization, compliance, and cost efficiency. * Champion best practices for digital sourcing, procurement analytics, supplier collaboration, and contract management. Application & Integration Management * Responsible for system configuration, enhancements and support for Coupa modules (Procure-to-Pay, Sourcing, Contract Lifecycle Management, Supplier Management, Invoicing). * Manage integrations between Coupa, SAP ERP , Workday , banking , and 3rd-party applications using middleware. * Lead upgrades, testing, and change control processes across Coupa and SAP landscapes. Operational Excellence * Ensure compliance with internal controls, audit, and regulatory requirements (SOX, GDPR, etc.). * Drive data quality and master data governance across supplier, contract, and spend domains. * Manage MSP and vendor resources ensuring SLA adherence and value realization. Team & Stakeholder Leadership * Lead developers, and functional consultants for projects and support. * Act as a trusted advisor to Procurement and Finance leaders for digital transformation opportunities. * Collaborate with IT peers across ERP, HR, and analytics functions to deliver integrated enterprise solutions. Key Core Competencies : * Expert in Coupa functional configuration and SAP integration (especially MM, FI, and AP modules). * Capable of translating complex business needs into scalable technical solutions. * Proficient with middleware SAP CPI and API-based integrations. * Knowledge of workflow automation , RPA , and data visualization tools (Power BI, Tableau) a plus. * Strong leadership, communication, and change management skills. Qualifications Education: Bachelor's degree in Information Systems, Finance, or Business Management (Master's preferred). Experience: * 8+ years of experience in enterprise applications or IT solution delivery. * 7+ years leading Source-to-Pay or Procure-to-Pay systems (preferably Coupa and SAP). * Proven experience managing large-scale ERP and SaaS integrations. * Strong understanding of end-to-end procurement, sourcing, invoicing, and payments processes. * Demonstrated success in project governance, vendor management, and stakeholder engagement. Preferred Certifications * Coupa Certified Professional. * SAP certification (MM, FI/CO, or Integration). The base salary range for this role is $169,400 to $211,800. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. 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 from time to time, as needed. Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. SMPA may use Artificial Intelligence ("AI") as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. Our Mission To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide Our Vision For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas

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 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 Purpose Leveraging a proven track record of leading at least 3 discovery programs to clinic, The Global Therapeutic Research Lead (G-TRL) is a pipeline critical strategic leader responsible for driving Research projects to the clinic. The individual will sit on the Neuroscience Drug Discovery Unit (NS DDU) Leadership Team. Leader for at least one or more of Takeda’s top priority small molecule 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 G-TRL builds a connected view of the project within the Neuroscience 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. G-TRLs are responsible for creating the medicine vision, early asset strategy and managing multiple external partnerships that accelerate delivery of the project. G-TRLs will establish smart, fast, and critical path minded practices for groups, including integrating new strategies and competitive industry ways of working. G-TRL 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 molecule 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 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 commercial team for asset commercial value within the Neuroscience Therapeutic Area (NS 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 Neuroscience 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): Advanced degree in health or life sciences (e.g., Ph.D., M.D., D.V.M.) 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 in small molecules and have insight into oligonucleotide and biologic 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. As part of our global R&D strategy, and unique to the Research organization’s strong lab presence in Shonan, Japan, this role may include the opportunity for a temporary or long-term international assignment in Japan, subject to business needs and final candidate selection. Candidates interested in global exposure are encouraged to apply. 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: $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

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 Early Development you will p rovide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development, maximizing global regulatory success and minimizing time to clinical milestones. Establish best practices and a strong regulatory community across Global Regulatory Affairs and CMC functions (process development, analytical, formulation, drug substance/drug product, device/combination where applicable, quality, clinical, and manufacturing) to ensure consistent, high-quality execution. Serve as an influential leader internally and externally, shaping early-development CMC regulatory policy, influencing cross-functional decision-making, and advancing adoption of in silico and digital approaches to product and process development across major regions (e.g., US, EU, Japan, China). * Leads and develops a team of regulatory leaders and subject matter experts, overseeing global CMC regulatory strategy and key submissions/health authority interactions for an assigned portfolio of small molecule and biologic products through Phase 2. * Partners with cross-functional leaders (CMC, Regulatory, Development, Clinical, Nonclinical, Quality, Safety, Manufacturing, Supply Chain, and Digital/Data) to align CMC development plans, to regional regulatory expectations and program timelines. * Ensures governance teams and key stakeholders are apprised of CMC developments impacting regulatory success (e.g., process/formulation changes, analytical readiness, control strategy evolution, comparability considerations, starting material strategy, impurity risk, raw material/supply risk). Anticipates risks and drives mitigation plans consistent with quality risk management principles. * Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice). * Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator's brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. * Leads departmental and cross-functional initiatives to advance fit-for-phase and platform approaches in early development CMC, including global harmonization of templates and positions, improved knowledge management, and readiness for accelerated programs (e.g., breakthrough/PRIME/RMAT where applicable). * Provides CMC regulatory strategy leadership for business development and due diligence, including assessment of early CMC maturity, comparability risks, prior knowledge leverage, and global filing feasibility for small molecules and biologics. * Monitors and anticipates global regulatory trends impacting early development CMC (e.g., ICH Q12/Q13/Q14/Q2(R2), nitrosamines, elemental impurities, biologics comparability, emerging expectations for modeling/simulation and structured data), translating insights into proactive CMC development and submission strategies. * Champions use of in silico approaches and digital capabilities in CMC (e.g., predictive impurity risk assessment, process and formulation modeling, PBPK/biopharmaceutics linkages where relevant, digital data lineage, and content re-use) to improve scientific justification, reduce cycle time, and strengthen global regulatory interactions. * 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 significant experience in Global Regulatory Affairs CMC (or closely related CMC regulatory experience), including leadership for small molecule and/or biologic products in early development * Significant experience leading, reviewing, authoring, or managing CMC content for global regulatory submissions and responses in early development (e.g., pre-IND/IND, CTA/IMPD, amendments, briefing packages, and major deficiency responses) and negotiating requirements with health authorities * Strong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements, including ICH guidance and regional expectations (FDA, EMA, MHRA, PMDA); experience across additional regions a plus. * Understands and interprets complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to CMC regulatory requirements and strategy, including impurity risk, analytical control strategy, specifications, stability strategy, and comparability (as applicable). * Demonstrated ability to drive fit-for-phase global CMC regulatory strategy, leveraging prior knowledge, platform capabilities, and risk-based approaches; experience integrating in silico modeling/simulation and digital data strategies into CMC development and regulatory justifications is strongly preferred. * Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. * Demonstrated ability to think strategically and operate with increasing independence, understanding implications across the organization and globally; proactively identifies CMC regulatory issues and offers innovative, risk-based solutions and 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

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 We are seeking a seasoned and visionary Senior Director of Medicinal Chemistry to join our leadership team. This individual will play a pivotal role in shaping the future direction of our company by providing strategic guidance and oversight to our medicinal chemistry efforts. The ideal candidate will be instrumental in driving our drug discovery initiatives forward, ensuring their successful progression and alignment with our company's overall goals and objectives. By leveraging their expertise, they will significantly influence our strategic decisions and contribute to the advancement of our scientific and commercial endeavors. Additionally, this person will oversee external programs at CROs, managing the design, execution, and progression of medicinal chemistry projects conducted exclusively at these organizations Accountabilities: * Create business development opportunities that meet the strategic scientific, therapeutic, and commercial needs of the organization or specific Therapeutic Area (TA). * Leadership and Strategy: Provide strategic leadership and oversight to the medicinal chemistry department, aligning with the company's overall goals and objectives. * Project Management: Oversee the design, execution, and management of medicinal chemistry projects conducted exclusively at CROs, ensuring timely progress and high-quality outcomes. * Team Development: Mentor and develop a team of internal chemists, fostering a collaborative and innovative work environment. * Collaboration: Work closely with cross-functional teams, including biology, pharmacology, and clinical development, to advance drug candidates from discovery through development. * Innovation: Drive innovation in medicinal chemistry through the integration of new technologies, methodologies, and best practices. * Regulatory Compliance: Ensure all activities comply with relevant regulatory requirements and industry standards. * External Partnerships: Build and maintain relationships with external partners, including academic institutions, industry collaborators, and contract research organizations. Education & Competencies (Technical and Behavioral): * Expected education and experience: PhD degree in Chemistry, Medicinal Chemistry or related discipline with 15+ years experience in small molecule projects. * Proven track record of leading successful drug discovery programs, preferably in large pharma. * Leadership Skills: Strong leadership and managerial skills with experience leading and developing high-performing teams. * Technical Expertise: Deep understanding of medicinal chemistry principles, drug design, and optimization processes. * Communication: Excellent verbal and written communication skills, with the ability to effectively communicate complex scientific concepts to a broad audience. * Problem-Solving: Strong analytical and problem-solving skills, with a proactive and innovative approach to challenges. * Collaboration: Proven ability to work collaboratively in a cross-functional team environment. * Adaptability: Ability to adapt to changing priorities and work effectively in a fast-paced and dynamic environment. Preferred Qualifications: * Experience: Experience in a leadership role within a large pharmaceutical or biotechnology company is highly desirable. * A proven track record of leading projects that are completely outsourced * Publications: A strong publication record in medicinal chemistry or related fields. * Patents: Experience with patent filings and intellectual property management. * Networking: Established network within the scientific and pharmaceutical community. * As part of our global R&D strategy, and unique to the Research organization's strong lab presence in Shonan, Japan, this role may include the opportunity for a temporary or long-term international assignment in Japan, subject to business needs and final candidate selection. Candidates interested in global exposure are encouraged to apply. 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: $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.

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 We are seeking a seasoned and visionary Senior Director of Medicinal Chemistry to join our leadership team. This individual will play a pivotal role in shaping the future direction of our company by providing strategic guidance and oversight to our medicinal chemistry efforts. The ideal candidate will be instrumental in driving our drug discovery initiatives forward, ensuring their successful progression and alignment with our company's overall goals and objectives. By leveraging their expertise, they will significantly influence our strategic decisions and contribute to the advancement of our scientific and commercial endeavors. Additionally, this person will oversee external programs at CROs, managing the design, execution, and progression of medicinal chemistry projects conducted exclusively at these organizations Accountabilities: * Create business development opportunities that meet the strategic scientific, therapeutic, and commercial needs of the organization or specific Therapeutic Area (TA). * Leadership and Strategy: Provide strategic leadership and oversight to the medicinal chemistry department, aligning with the company's overall goals and objectives. * Project Management: Oversee the design, execution, and management of medicinal chemistry projects conducted exclusively at CROs, ensuring timely progress and high-quality outcomes. * Team Development: Mentor and develop a team of internal chemists, fostering a collaborative and innovative work environment. * Collaboration: Work closely with cross-functional teams, including biology, pharmacology, and clinical development, to advance drug candidates from discovery through development. * Innovation: Drive innovation in medicinal chemistry through the integration of new technologies, methodologies, and best practices. * Regulatory Compliance: Ensure all activities comply with relevant regulatory requirements and industry standards. * External Partnerships: Build and maintain relationships with external partners, including academic institutions, industry collaborators, and contract research organizations. Education & Competencies (Technical and Behavioral): * Expected education and experience: PhD degree in Chemistry, Medicinal Chemistry or related discipline with 15+ years experience in small molecule projects. * Proven track record of leading successful drug discovery programs, preferably in large pharma. * Leadership Skills: Strong leadership and managerial skills with experience leading and developing high-performing teams. * Technical Expertise: Deep understanding of medicinal chemistry principles, drug design, and optimization processes. * Communication: Excellent verbal and written communication skills, with the ability to effectively communicate complex scientific concepts to a broad audience. * Problem-Solving: Strong analytical and problem-solving skills, with a proactive and innovative approach to challenges. * Collaboration: Proven ability to work collaboratively in a cross-functional team environment. * Adaptability: Ability to adapt to changing priorities and work effectively in a fast-paced and dynamic environment. Preferred Qualifications: * Experience: Experience in a leadership role within a large pharmaceutical or biotechnology company is highly desirable. * A proven track record of leading projects that are completely outsourced * Publications: A strong publication record in medicinal chemistry or related fields. * Patents: Experience with patent filings and intellectual property management. * Networking: Established network within the scientific and pharmaceutical community. * As part of our global R&D strategy, and unique to the Research organization's strong lab presence in Shonan, Japan, this role may include the opportunity for a temporary or long-term international assignment in Japan, subject to business needs and final candidate selection. Candidates interested in global exposure are encouraged to apply. 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: $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.

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 OBJECTIVES: The Head, CAPTIVATE (Planisware Enablement, Portfolio Management & Capacity Planning Excellence) is the senior business leader accountable for implementing and scaling Planisware as Takeda R&D's primary capability for integrated portfolio planning, timeline governance, resource/capacity management, and financial forecasting . This role owns the business strategy, operating model, and outcomes for Planisware, driving standardized ways of working, cross-functional adoption, and measurable improvements in portfolio decision-making and execution predictability. The Head, CAPTIVATE (Planisware Enablement, Portfolio Management & Capacity Planning Excellence) leads through influence in a global matrix and governs delivery partners to ensure a high-quality, sustainable and effective solution. ACCOUNTABILITIES: Business ownership & product leadership * Serves as the business Product Owner for Planisware in R&D, defining vision, value case, and a multi-year roadmap aligned to R&D and Takeda enterprise strategy * Ensures appropriate allocation of internal resources and owns outcomes for scope, value realization and delivery, in partnership with DD&T and system integrators * Establishes clear governance including decision rights, design authority, release cadence and prioritization to ensure consistent high-quality delivery * Builds a sustainable and efficient operating model encompassing process ownership, super-user networks, training, support and enhancement intake Enterprise implementation & change * Leads end-to-end implementation from future-state design through deployment and stabilization (requirements, configuration governance, UAT, cut-over, training, hypercare) * Sponsors and drives change management: executive alignment, communications, role-based enablement, and adoption embedded into governance forums and project rhythms Portfolio, resource, and financial management uplift * Ensures cross-functional alignment for R&D standards and controls across project, resource planning, cost planning and forecasting. * Sets the strategy & roadmap for portfolio management, resource and capacity planning & forecasting capabilities, enabled through CAPTIVATE, ensuring alignment to R&D and enterprise priorities * Partners with R&D Functions, TAUs, Global Medical Affairs, Global Finance, SPD and DD&T, etc. to identify requirements which address the most critical portfolio decisions and execution risks. * Accountable for ensuring the platform will deliver decision-ready insights that measurable improve decision quality, speed and execution predictability for functions and governance bodies. Matrix leadership & stakeholder alignment Owns vendor and system integrator governance: SOWs, deliverables, quality, timelines, RAID management, and budget oversight * Ensures effective knowledge transfer, documentation, and transition to a steady-state support model Data governance, reporting, and compliance * Establishes master data ownership, data quality metrics, and audit-ready controls for portfolio, resource, and financial data * Delivers executive dashboards and performance KPIs; ensures consistent definitions and trusted reporting EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Required * Proven drug development experience as a senior leader in global program or portfolio management in biotech/pharma, including oversight of complex, cross-functional initiatives spanning multiple geographies, functions, and governance bodies * Depth of experience in GPT management and Takeda business processes * Depth in resource/capacity planning and financial planning/forecasting concepts; ability to translate business and program needs into system requirements * Strong matrix leadership and executive stakeholder management skills; ability to influence without authority * Hands-on experience (leadership preferred) of PPM implementations (Planisware preferred) including process design, adoption, training and operating model establishment * Proven vendor management (SI + software vendor), including commercial oversight and delivery governance * Ability to influence and negotiate successfully in a matrix environment to optimize development and address barriers * Proactive risk management experience with ability to propose solutions and deliver appropriate mitigation plans * Ability to communicate (written and verbal) with impact to provide appropriate context, articulate views, drive clarity, and address barriers to program development * Ability to inspire, motivate and drive decision-making within a cross-functional and cross-cultural, global team structure Preferred * Demonstrated mastery in program management of complex assets and/or in portfolio strategy/analytics within a therapeutic portfolio, preferably across an R&D portfolio * Experience building robust portfolio and program valuation models in partnership with Finance and Program Leadership to support trade-off discussions and risk assessments * Experience with global R&D operating models and cross-functional resource ownership * Familiarity with integrations to finance/ERP, HR systems, and analytics platforms; data governance experience * Change leadership and product-oriented delivery practices Organization / interfaces (typical) 12-15+ years of in-depth biopharmaceutical industry and drug development experience across all phases of development; significant experience interfacing within related functions (e.g. Clinical Science, Clinical Operations, Research, Regulatory, CMC, Marketing) * 10+ years global program management experience leading complex biopharmaceutical projects in a multi-disciplinary, global environment * Demonstrated ability to lead complex programs and positively influence outcomes, key project decisions, and strategic problem-solving * Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management LICENSES/CERTIFICATIONS: May travel to the US, EU and Japan offices and other international locations * Approximately 10% travel is required * 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: $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.

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 DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Medical Director, Solid Tumor in our Cambridge 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.OBJECTIVES: The Senior Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for multiple Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual influences TGRD and TPC senior leadership decision-making by setting strategic direction. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products.ACCOUNTABILITIES: Clinical Development team participation and leadership Leads the Global Development Team (US, EU, Japan) managing both the US/EU Development Team and the Japan Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the clinical scientist responsible for leading this team. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles.Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.Synopsis / Protocol Development, Study Execution, & Study Interpretation Drives all Clinical Science department activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to the clinical scientists involved in these activities, and be accountable to senior company management for the successful completion of underlying objectives. For the assigned compounds, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals.Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.Trial Medical Monitoring Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with Pharmacovigilance. External Interactions Directs activities involved in interactions with regulatory authorites/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.Due Diligence, Business Development and Alliance Projects Responsible for identification and evaluation of potential business development opportunities, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC.Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Provides guidance to clinical scientists who are involved in some of these activities.Leadership, Task Force Participation, Upper Management Accountability Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge/understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. Represents clinical science on high impact/priority task forces across the organization or external to the company. Leads TGRD internal teams and global cross-functional teams.Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning.EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: MD or internationally recognized equivalent plus 7 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned). Includes 3-4 years of late phase clinical development experienceTraining and Experience in Hematology/ Oncology and/or Medical Oncology especially in solid tumor malignancies is highly preferredExperience in conducting and/ or leading clinical trials in involving immune based therapies and/or antibody drug conjugates is highly preferred Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Development experience beyond US/EU a plus.NDA/MAA/Submission experience preferredExcellent communication and influencing skills, with the ability to engage, inspire, and influence stakeholders at all levels, including executive management and external partners.Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferredSkillsSuperior communication, strategic, interpersonal and negotiating skillsAbility to proactively predict issues and solve problemsAbility to drive decision-making within a multi-disciplinary, multi-regional, matrix teamsDiplomacy and positive influencing abilities across multinational business culturesKnowledgeTherapeutic area knowledge relevant to mechanisms of action of compounds in remitRegional/global Regulatory requirementsGCP/ICHEmerging research in designated therapeutic areaTRAVEL REQUIREMENTS:Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.Requires approximately 15 - 25% travel.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 orientatio

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 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 Early Development you will provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development, maximizing global regulatory success and minimizing time to clinical milestones.Establish best practices and a strong regulatory community across Global Regulatory Affairs and CMC functions (process development, analytical, formulation, drug substance/drug product, device/combination where applicable, quality, clinical, and manufacturing) to ensure consistent, high-quality execution.Serve as an influential leader internally and externally, shaping early-development CMC regulatory policy, influencing cross-functional decision-making, and advancing adoption of in silico and digital approaches to product and process development across major regions (e.g., US, EU, Japan, China).How you will contribute:Leads and develops a team of regulatory leaders and subject matter experts, overseeing global CMC regulatory strategy and key submissions/health authority interactions for an assigned portfolio of small molecule and biologic products through Phase 2.Partners with cross-functional leaders (CMC, Regulatory, Development, Clinical, Nonclinical, Quality, Safety, Manufacturing, Supply Chain, and Digital/Data) to align CMC development plans, to regional regulatory expectations and program timelines.Ensures governance teams and key stakeholders are apprised of CMC developments impacting regulatory success (e.g., process/formulation changes, analytical readiness, control strategy evolution, comparability considerations, starting material strategy, impurity risk, raw material/supply risk). Anticipates risks and drives mitigation plans consistent with quality risk management principles.Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator’s brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation.Leads departmental and cross-functional initiatives to advance fit-for-phase and platform approaches in early development CMC, including global harmonization of templates and positions, improved knowledge management, and readiness for accelerated programs (e.g., breakthrough/PRIME/RMAT where applicable).Provides CMC regulatory strategy leadership for business development and due diligence, including assessment of early CMC maturity, comparability risks, prior knowledge leverage, and global filing feasibility for small molecules and biologics.Monitors and anticipates global regulatory trends impacting early development CMC (e.g., ICH Q12/Q13/Q14/Q2(R2), nitrosamines, elemental impurities, biologics comparability, emerging expectations for modeling/simulation and structured data), translating insights into proactive CMC development and submission strategies.Champions use of in silico approaches and digital capabilities in CMC (e.g., predictive impurity risk assessment, process and formulation modeling, PBPK/biopharmaceutics linkages where relevant, digital data lineage, and content re-use) to improve scientific justification, reduce cycle time, and strengthen global regulatory interactions.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 significant experience in Global Regulatory Affairs CMC (or closely related CMC regulatory experience), including leadership for small molecule and/or biologic products in early developmentSignificant experience leading, reviewing, authoring, or managing CMC content for global regulatory submissions and responses in early development (e.g., pre-IND/IND, CTA/IMPD, amendments, briefing packages, and major deficiency responses) and negotiating requirements with health authoritiesStrong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements, including ICH guidance and regional expectations (FDA, EMA, MHRA, PMDA); experience across additional regions a plus.Understands and interprets complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to CMC regulatory requirements and strategy, including impurity risk, analytical control strategy, specifications, stability strategy, and comparability (as applicable).Demonstrated ability to drive fit-for-phase global CMC regulatory strategy, leveraging prior knowledge, platform capabilities, and risk-based approaches; experience integrating in silico modeling/simulation and digital data strategies into CMC development and regulatory justifications is strongly preferred.Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.Demonstrated ability to think strategically and operate with increasing independence, understanding implications across the organization and globally; proactively identifies CMC regulatory issues and offers innovative, risk-based solutions and 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 Takeda's 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

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 Purpose Leveraging a proven track record of leading at least 3 discovery programs to clinic, The Global Therapeutic Research Lead (G-TRL) is a pipeline critical strategic leader responsible for driving Research projects to the clinic. The individual will sit on the Neuroscience Drug Discovery Unit (NS DDU) Leadership Team. Leader for at least one or more of Takeda’s top priority small molecule 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 G-TRL builds a connected view of the project within the Neuroscience 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. G-TRLs are responsible for creating the medicine vision, early asset strategy and managing multiple external partnerships that accelerate delivery of the project. G-TRLs will establish smart, fast, and critical path minded practices for groups, including integrating new strategies and competitive industry ways of working. G-TRL 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 molecule 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 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 commercial team for asset commercial value within the Neuroscience Therapeutic Area (NS 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 Neuroscience 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): Advanced degree in health or life sciences (e.g., Ph.D., M.D., D.V.M.) 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 in small molecules and have insight into oligonucleotide and biologic 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. As part of our global R&D strategy, and unique to the Research organization’s strong lab presence in Shonan, Japan, this role may include the opportunity for a temporary or long-term international assignment in Japan, subject to business needs and final candidate selection. Candidates interested in global exposure are encouraged to apply. 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: $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 <

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 Purpose Leveraging a proven track record of leading at least 3 discovery programs to clinic, The Global Therapeutic Research Lead (G-TRL) is a pipeline critical strategic leader responsible for driving Research projects to the clinic. The individual will sit on the Neuroscience Drug Discovery Unit (NS DDU) Leadership Team. Leader for at least one or more of Takeda’s top priority small molecule 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 G-TRL builds a connected view of the project within the Neuroscience 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. G-TRLs are responsible for creating the medicine vision, early asset strategy and managing multiple external partnerships that accelerate delivery of the project. G-TRLs will establish smart, fast, and critical path minded practices for groups, including integrating new strategies and competitive industry ways of working. G-TRL 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 molecule 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 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 commercial team for asset commercial value within the Neuroscience Therapeutic Area (NS 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 Neuroscience 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): Advanced degree in health or life sciences (e.g., Ph.D., M.D., D.V.M.) 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 in small molecules and have insight into oligonucleotide and biologic 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. As part of our global R&D strategy, and unique to the Research organization’s strong lab presence in Shonan, Japan, this role may include the opportunity for a temporary or long-term international assignment in Japan, subject to business needs and final candidate selection. Candidates interested in global exposure are encouraged to apply. 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: $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 <

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 a Medical Director, Clinical Science, Solid Tumor in our Cambridge 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. OBJECTIVES: The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences TGRD and TPC senior leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products. ACCOUNTABILITIES: Clinical Development team participation and leadership Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy. Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and commercial viability of a product. Synopsis / Protocol Development, Study Execution, & Study Interpretation Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy. Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients. Trial Medical Monitoring Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues. Makes final decisions regarding study conduct related to scientific integrity. External Interactions Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives. Due Diligence, Business Development and Alliance Projects Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Leadership, Task Force Participation, Upper Management Accountability Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross-functional teams, as appropriate. Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Education/ Experience MD, combined MD/PhD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned). Training and Experience in Hematology/ Oncology and/or Medical Oncology especially in solid tumor malignancies is preferred Experience in conducting and/or leading clinical trials involving immune-based therapies and/or antibody-drug conjugates is preferred. Late phase clinical development and NDA/MAA/Submission experience is preferred. Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Management experience Skills Excellent communication and influencing skills, with the ability to engage, inspire, and influence stakeholders at all levels, including executive management and external partners.Ability to proactively predict issues and solve problems Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams Diplomacy and positive influencing abilities Knowledge Therapeutic area knowledge relevant to mechanism of action Regional/global Regulatory requirements GCP/ICH Emerging research in designated therapeutic area TRAVEL REQUIREMENTS: Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 15 - 25% travel. Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regar <

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 DescriptionWe are seeking a seasoned and visionary Senior Director of Medicinal Chemistry to join our leadership team. This individual will play a pivotal role in shaping the future direction of our company by providing strategic guidance and oversight to our medicinal chemistry efforts. The ideal candidate will be instrumental in driving our drug discovery initiatives forward, ensuring their successful progression and alignment with our company's overall goals and objectives. By leveraging their expertise, they will significantly influence our strategic decisions and contribute to the advancement of our scientific and commercial endeavors. Additionally, this person will oversee external programs at CROs, managing the design, execution, and progression of medicinal chemistry projects conducted exclusively at these organizations Accountabilities: Create business development opportunities that meet the strategic scientific, therapeutic, and commercial needs of the organization or specific Therapeutic Area (TA).Leadership and Strategy: Provide strategic leadership and oversight to the medicinal chemistry department, aligning with the company's overall goals and objectives.Project Management: Oversee the design, execution, and management of medicinal chemistry projects conducted exclusively at CROs, ensuring timely progress and high-quality outcomes.Team Development: Mentor and develop a team of internal chemists, fostering a collaborative and innovative work environment.Collaboration: Work closely with cross-functional teams, including biology, pharmacology, and clinical development, to advance drug candidates from discovery through development.Innovation: Drive innovation in medicinal chemistry through the integration of new technologies, methodologies, and best practices.Regulatory Compliance: Ensure all activities comply with relevant regulatory requirements and industry standards.External Partnerships: Build and maintain relationships with external partners, including academic institutions, industry collaborators, and contract research organizations. Education & Competencies (Technical and Behavioral): Expected education and experience: PhD degree in Chemistry, Medicinal Chemistry or related discipline with 15+ years experience in small molecule projects.Proven track record of leading successful drug discovery programs, preferably in large pharma.Leadership Skills: Strong leadership and managerial skills with experience leading and developing high-performing teams.Technical Expertise: Deep understanding of medicinal chemistry principles, drug design, and optimization processes.Communication: Excellent verbal and written communication skills, with the ability to effectively communicate complex scientific concepts to a broad audience.Problem-Solving: Strong analytical and problem-solving skills, with a proactive and innovative approach to challenges.Collaboration: Proven ability to work collaboratively in a cross-functional team environment.Adaptability: Ability to adapt to changing priorities and work effectively in a fast-paced and dynamic environment. Preferred Qualifications:Experience: Experience in a leadership role within a large pharmaceutical or biotechnology company is highly desirable.A proven track record of leading projects that are completely outsourcedPublications: A strong publication record in medicinal chemistry or related fields.Patents: Experience with patent filings and intellectual property management.Networking: Established network within the scientific and pharmaceutical community.As part of our global R&D strategy, and unique to the Research organization’s strong lab presence in Shonan, Japan, this role may include the opportunity for a temporary or long-term international assignment in Japan, subject to business needs and final candidate selection. Candidates interested in global exposure are encouraged to apply.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:$208,200.00 - $327,140.00The 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 DescriptionWe are seeking a seasoned and visionary Senior Director of Medicinal Chemistry to join our leadership team. This individual will play a pivotal role in shaping the future direction of our company by providing strategic guidance and oversight to our medicinal chemistry efforts. The ideal candidate will be instrumental in driving our drug discovery initiatives forward, ensuring their successful progression and alignment with our company's overall goals and objectives. By leveraging their expertise, they will significantly influence our strategic decisions and contribute to the advancement of our scientific and commercial endeavors. Additionally, this person will oversee external programs at CROs, managing the design, execution, and progression of medicinal chemistry projects conducted exclusively at these organizations Accountabilities: Create business development opportunities that meet the strategic scientific, therapeutic, and commercial needs of the organization or specific Therapeutic Area (TA).Leadership and Strategy: Provide strategic leadership and oversight to the medicinal chemistry department, aligning with the company's overall goals and objectives.Project Management: Oversee the design, execution, and management of medicinal chemistry projects conducted exclusively at CROs, ensuring timely progress and high-quality outcomes.Team Development: Mentor and develop a team of internal chemists, fostering a collaborative and innovative work environment.Collaboration: Work closely with cross-functional teams, including biology, pharmacology, and clinical development, to advance drug candidates from discovery through development.Innovation: Drive innovation in medicinal chemistry through the integration of new technologies, methodologies, and best practices.Regulatory Compliance: Ensure all activities comply with relevant regulatory requirements and industry standards.External Partnerships: Build and maintain relationships with external partners, including academic institutions, industry collaborators, and contract research organizations. Education & Competencies (Technical and Behavioral): Expected education and experience: PhD degree in Chemistry, Medicinal Chemistry or related discipline with 15+ years experience in small molecule projects.Proven track record of leading successful drug discovery programs, preferably in large pharma.Leadership Skills: Strong leadership and managerial skills with experience leading and developing high-performing teams.Technical Expertise: Deep understanding of medicinal chemistry principles, drug design, and optimization processes.Communication: Excellent verbal and written communication skills, with the ability to effectively communicate complex scientific concepts to a broad audience.Problem-Solving: Strong analytical and problem-solving skills, with a proactive and innovative approach to challenges.Collaboration: Proven ability to work collaboratively in a cross-functional team environment.Adaptability: Ability to adapt to changing priorities and work effectively in a fast-paced and dynamic environment. Preferred Qualifications:Experience: Experience in a leadership role within a large pharmaceutical or biotechnology company is highly desirable.A proven track record of leading projects that are completely outsourcedPublications: A strong publication record in medicinal chemistry or related fields.Patents: Experience with patent filings and intellectual property management.Networking: Established network within the scientific and pharmaceutical community.As part of our global R&D strategy, and unique to the Research organization’s strong lab presence in Shonan, Japan, this role may include the opportunity for a temporary or long-term international assignment in Japan, subject to business needs and final candidate selection. Candidates interested in global exposure are encouraged to apply.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:$208,200.00 - $327,140.00The 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.

As a Senior Strategy Analyst at New Balance, you will be supporting the Asia Pacific & Japan regions. Develop and communicate insights that influence senior leaders globally and regionally. Drive strategic initiatives across APAC & Japan by partnering with senior leaders and cross-functional teams t

Job Description Crimson Education is the world’s leading college admissions consulting firm, with over 1,490 Ivy League offers and 2,410 to the US Top 15. We help ambitious students gain admission to the world’s top universities through expert-led guidance and proven, data-driven strategies. Crimson students are 7x more likely to get into the Ivy League than their peers. We were recently featured on the front page of the Wall Street Journal. Crimson is the only college admissions consultancy that brings together: * Former Ivy League and Top 20 admissions officers to rigorously review and refine applications * Professors and PhD teaching fellows from leading universities to guide students through original, independent research — with pathways to selective peer-reviewed publication or conference presentation * Past ISEF winners and judges who coach students to compete for state, national, and international science fair awards * Capstone project mentors who help students design and scale leadership initiatives with real-world impact, measurable outcomes, and credible external validation We’re backed by leading VC firms, including Tiger Global, Heal Partners, IceHouse Ventures, and Movac, and recently closed a USD $40M Series D funding round at a USD $640M valuation. We now operate across 21 markets worldwide, including the US, Canada, UK, Singapore, Japan, Hong Kong, Australia, and New Zealand. The Role We are seeking a driven and commercially minded Regional Marketing & Business Development Manager to own Crimson’s presence and growth across the designated US region. This is a dual-focus, high-impact role that sits at the intersection of brand building, community engagement, partnership development, and event management. You will be the face of Crimson in your region — cultivating relationships, producing compelling local content, orchestrating events, and driving tangible revenue outcomes. If you are entrepreneurial, organized, and energized by connecting with people and communities, this role is for you. Location: This is a region-based role within the United States. You will work primarily in and around the Boston area. A degree of flexibility in working hours is required, including availability on select evenings and weekends to attend and support events alongside Crimson staff and partners. What are the main responsibilities for this role? Regional Brand & Market Development * Take full ownership of Crimson’s brand presence and market growth across your assigned region. * Design and execute localized marketing campaigns to promote events — both live and virtual — to relevant audiences. * Identify, form, and nurture meaningful partnerships with schools, community organizations, educational institutions, and other relevant local entities. * Manage partner relationships strategically to maximize mutual value and long-term return. Event Management * Manage live events end-to-end: from venue sourcing and logistics, through speaker engagement, to on-the-day execution and post-event follow-up. * Develop and distribute tailored, regionalized event follow-up communications to sustain audience engagement and drive conversion. * Maintain a presence at events, including on evenings and weekends where required. Content Creation & Performance Tracking * Produce relevant, high-quality local content, including slide decks, eBooks, advertising copy, and email communications. * Track and report on the performance of regional activities, with a focus on revenue attribution and campaign effectiveness. * Bring a data-informed mindset to continuously refine your approach and maximize local impact What skills and experience are required? * 3–5 years of experience in marketing, events, business development, or a closely related field. * Demonstrated ability to manage events from conception through to execution and follow-up. * A track record of developing and maintaining productive external partnerships. * Strong written communication skills, with experience producing marketing and content assets. * Comfortable working both independently and collaboratively in a fast-paced, growth-oriented environment. * Highly organized with excellent attention to detail and the ability to manage multiple priorities simultaneously. * Familiarity with performance tracking, reporting, and a results-oriented mindset. * A genuine passion for education and the belief that access to great guidance can transform a student’s future. Why work for Crimson? * Rapidly growing start up, with a flexible working environment where you will be empowered to structure how you work * Limitless development and exposure - our internal promotions/role changes made up 33% of all recruitment last year * $1000 individual training budget per year, we love to ‘Level Up’ (it’s one of our core values)! * Psychologist on staff * Insightful fireside chats and workshops to help support our high-performing and ambitious team * Radical Candor is a feedback approach we live by * We’re a global player with 28 markets (and growing) across the globe. Most roles have the option to work from one of our many offices or remotely! If you're passionate about growing in a fast-paced, collaborative environment and want to work with cutting-edge technology, then we'd love to hear from you! Please keep an eye on your spam/junk email folder for correspondence from Team Tailor.

Job DescriptionAre you ready to be part of a leading global engineering design house specializing in the design and development of state-of-the-art embedded hardware, electronics, and electro-mechanics? What we’re looking for: -Highly motivated professionals•Motivated Hardware Designer •Professionals with ability to work both with in-house projects and on-site assignments at our customers’ locations What you’ll do -Work in a cross-functional development team where continuous improvement, innovation, and knowledge sharing are part of daily work.•Perform full-cycle hardware development including requirement analysis, block diagrams, schematic capture, and generating design specifications.•Collaborate closely with the PCB layout team to produce high-quality, reliable boards that meet performance, manufacturability, and testability requirements.•Execute designer verification activities, including writing and running test plans, analyzing results, and ensuring compliance with industry and military standards. What you’ll need to get the job done -Bachelor’s or Master’s degree in electrical engineering, Telecommunication, or a related discipline coupled with 12+ years of design experience.•Experience in designing systems for robotics applications.•Strong understanding of analog and digital circuit design, including power supplies, signal conditioning, ADC/DAC conversion, and sensors.•Proficiency with microcontrollers, memory interfaces, and embedded hardware architecture.•Experience with high-speed interfaces and serial communication protocols such as USB, Ethernet, LVDS, PCIe, GMSL, JESD204C, HDMI etc.•Ability to capture schematics, review datasheets, and work collaboratively with engineers across disciplines.•Competence in EMC/EMI principles, troubleshooting, and implementing design-level mitigations (filters, shielding, grounding strategies).•Familiarity with constraints management and coordinating PCB layout activities to ensure electrical and mechanical performance.•Experience with SI and PI tools, principles and design strategies•Hands-on experience using standard lab equipment and design verification techniques.•Ability to drive issues to closure, work methodically, and participate in structured design and technical reviews. What will make us REALLY love you -A friendly willingness to collaborate, share knowledge, and communicate effectively with cross-functional teams.•A clear passion for project-based work, continuous learning, and staying at the top of your technical game. What you’ll love about us -Company Culture – outstanding people and a flexible work environment.•Career Growth Opportunities – being a design house keeps variety in your work. New opportunities happening all the time!•Global Design House – since Syntronic is a global Design House, you will probably work with in a team with engineers from other Syntronic sites (Canada, Sweden, China, Malaysia, Japan). Who we are Syntronic provides our customers a complete portfolio of professional services to support their product development including research & development, new product introduction, manufacturing and aftermarket services. We adopt the latest technologies in electronics design and software development with a pool of technically skilled staff around the world. Among our customers and partners are some of the world’s most technically-intensive businesses and organizations. This pushes us forward in designing to satisfy our customers’ needs with a focus on quality, competence, capacity and continuity. Syntronic has today over 2000 employees in 8 countries. Syntronic values diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you require accommodation due to a disability at any time during the recruitment and/or assessment process, please contact our recruiting team and we will make all reasonable efforts to accommodate your request. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Title: Area Sales Manager Reports to: Sales Manager Location: DMG MORI USA Hours: Core Business Hours Classification: Exempt Travel: 80% or more Employment is conditioned on DMG MORI's ability to obtain and maintain any necessary export licensing. The Area Sales Manager (ASM) is principally responsible for the sale of DMG MORI products to provide innovative solutions to customer work requirements on DMG MORI machine tools. The position reports to the Regional Sales Director on the development of prospective accounts and retention of current customers. Essential Job Functions: To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. • Building and fostering customer relationships., • Promoting the sale of Company products, and providing technical sales support., • Conferring with Applications Engineers to assess equipment needs., • Developing, presenting, or responding to proposals for specific customer requirements., • Recommending improved materials or machinery to customers., • Proactively visit customer facilities for review of outstanding engineering and service related problems, including strategic review of sales opportunities for up to, but not limited to, a minimum of 25 visits per week, • Proactively visit customer facilities in order to resolve difficult engineering issues., • Report requirements: Territory Planning and MIS reports are to be submitted weekly. Expense reports are to be submitted timely, per expense policy requirements., • Semiannual visits to OEM factories in Japan, Germany, Italy, and China., • Develop strategic and tactical plans in order to accomplish yearly sales goals., • Partner with engineering staff for demonstrations., • Other duties as assigned. Minimal Requirements • Preferred: Bachelor’s Degree from an accredited university., • Associate’s Degree from an accredited university, • 5-10 years in technical sales experience, • Recent experience in machine tool environments preferred. Work Environment: General office environment will be experienced. There will be periodic exposure to manufacturing environments which may present possible hazards such as noise, electricity, chemicals, heavy equipment, and other automated and manual machinery. Physical Demands: Frequent: Traveling, operating a vehicle, sitting at desk, utilizing computers and phones, standing and walking. Periodic: Repetitive foot, leg, hand, arm, shoulder, and torso movements. Occasional: Bending, squatting, stooping, and reaching. Pushing, pulling, and lifting objects. We are an Equal Opportunity Employer. We maintain a drug-free workplace and perform pre-employment substance abuse screening

Job Description Join the Market Leader in Electric Power Data and Analytics Solutions The electrical grid is the largest and most complicated machine ever built. Yes Energy's industry-leading electric power trading analytics software provides real-time visibility into the massive amount of data generated by the North American electrical grid daily. Our unique and innovative view of the data informs real-time trading decisions and mid-to-long-term investment decisions that keep utility prices low, support the energy transition, and keep the grid running. It's both challenging work and work with a purpose. Be a part of our successful, growing business during international transformation. Position Summary As a Security Analyst II, you will be helping keep the grid safe and our customers secure. You will be part of our growing Security & Compliance team, building security automations, creating baselines for on-premises and cloud environments, assisting teams with vulnerability scans and management, supporting our compliance team with evidence gathering and audits, and more. This is an opportunity to be part of a small team with increasing importance and responsibility. You will help Yes Energy stay secure into the future. Position Details • Salary range: 80,000 - 95,000, • Location: Yes Energy Core Offices or Remote, • Full-time, • Reporting to: Senior Manager, IT and Compliance, • Review and triage findings from vulnerability scans, penetration tests, and configuration assessments to identify potential security risks., • Work with DevOps, engineers, and system owners to remediate vulnerabilities across multi-cloud and on-prem assets., • Support secure configuration baselines for AWS, Azure, and Oracle Cloud resources., • Monitor cloud environments for misconfigurations and suspicious activity., • Assist with IAM policy reviews and privilege audits., • Write scripts (Python, PowerShell, or Bash) to automate detection, reporting, or remediation of security issues., • Integrate security tools and data into dashboards or workflow systems (e.g., Jira, SIEM, or ticketing)., • Provide technical evidence and control implementation support for SOC 2, ISO 27001, or customer security assessments., • Partner with the compliance team to map technical controls to framework requirements., • Assist with incident triage, response, and root cause analysis., • Bachelor's degree in a related field or equivalent related experience, • Minimum of two years of experience with security exposure in information security, systems administration, or DevOps., • Proficient in at least one scripting language (Python, PowerShell, or Bash)., • Strong understanding of operating systems, networking, and cloud fundamentals., • Knowledge of security frameworks such as NIST, • Familiarity with vulnerability management tools (e.g., Tenable, Qualys, Rapid7, AWS Inspector, or Microsoft Defender)., • Working knowledge of AWS, Azure, and/or Oracle Cloud security controls and services., • Ability to travel up to 15% to assist in team building and planning exercises., • Strong, professional communication skills, both verbal and written, including the skill in articulating and translating technical language to non-technical customers., • Ability to plan for contingencies and anticipate problems., • Experience with SIEM or SOAR platforms (e.g., Splunk, Microsoft Sentinel)., • Familiarity with infrastructure such as code (Terraform, CloudFormation)., • Exposure to compliance frameworks such as SOC 2, ISO 27001, or NIST 800-53., • Security certifications (Security+, GSEC, AWS Security Specialty, or similar)., • Endpoint Security/Patching/Inventory experience At Yes Energy, we value connecting directly with candidates. We kindly ask that third-party recruiters and agencies not submit resumes, as we are not open to external recruiting partnerships. ABOUT YES ENERGY Overview Yes Energy delivers real-time market data and electric power trading decision solutions. Over 1,000 market participants use Yes Energy solutions daily. The business is a leader in all aspects of information content collection and management, developing and delivering data and market analytics solutions. Since its inception in 2008, Yes Energy has become a trusted and respected supplier of innovative and reliable solutions focused on the needs of power market analysts, traders, and trade managers. Yes Energy has a team of over 350 amazing professionals in Boulder, CO (HQ); Boston, MA; Chicago, IL; Glendora, CA; Richmond, VA; London, United Kingdom; Auckland, New Zealand, Tokyo, Japan; and Bucharest, Romania. Culture Yes Energy has been named one of the Best Places to Work in Colorado, and we have the culture to prove it. At Yes Energy, we care about saying "Yes" to customers. We like to listen, learn, and develop our solutions in line with their needs. We think about customers as business partners, and when we help them be more successful … we are more successful, too. Around the office, our culture is driven by some pretty fundamental values that we're proud of: • We love innovation and solving tough challenges;, • We are "high standards people" who combine passion and pride with hard work and rewards of all kinds-- in an ethic that is consistent across the company;, • We're team-focused with a flat hierarchy-- we work in small teams on well-defined projects that directly impact the success of the business;, • We play to the strengths and experience of each person while each of us also works along a continuum of roles adjacent to our focus area. This presents the challenge of maintaining a broad set of skills as well as an opportunity to learn and contribute in many ways; We offer highly competitive salaries and real bonuses that are achievable and that you can impact. Our benefits package is also very competitive, including medical insurance, a 401 (k) Plan with matching, flexible vacation, and flexible work schedules. Yes Energy encourages and funds investment in both formal and informal professional development. At Yes Energy, we are dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role but your experience doesn't perfectly align with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles. In accordance with Colorado law, the range provided is Yes Energy's reasonable estimate of the base compensation for this role. The actual amount may be higher or lower based on non-discriminatory factors such as location, experience, knowledge, skills, and abilities. Yes Energy provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Yes Energy complies with applicable state and local laws governing nondiscrimination in employment in every location where the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. #LI-Hybrid

Job Description Job description: Business Development - Mandarin Speaking About HungryPanda Founded in 2017, HungryPanda is currently the largest overseas Asian food delivery platform. Starting in Nottingham, U.K., HungryPanda has expanded to more than 80 cities in 10 countries: the U.K., France, Italy, the U.S., Canada, Australia, New Zealand, Japan, South Korea and Singapore. Currently, HungryPanda works with over 80,000 riders, 100,000 merchants and serves over 6 million users worldwide. Main Duties and Responsibilities • Identify and recruit potential merchants (restaurants, stores, etc.) to join our platform, presenting our product offerings and services to drive onboarding and successful partnerships., • Conduct frequent in-person visits to merchants in target areas to pitch cooperation, negotiate partnership agreements, and complete onboarding procedures., • Maintain and strengthen long-term merchant relationships by providing regular business support, conducting routine visits, and addressing operational or service-related concerns., • Work closely with each onboarded merchant to develop customized platform strategies, help optimize their performance, and grow order volume and Gross Merchandise Volume (GMV)., • Propose and coordinate promotional campaigns or value-added services in collaboration with the Marketing team to increase merchant exposure and transaction frequency., • Continuously manage and update merchant backend data and settings to ensure smooth operations, accurate information, and performance tracking., • Fluency in Mandarin Chinese is required; proficiency in English is a plus., • Previous experience in B2B sales, merchant acquisition, or offline business development is highly desirable., • Familiarity with the food delivery industry, local retail, or internet platform operations is a strong advantage., • Strong interpersonal and negotiation skills; confident communicating and building trust with business owners., • Ability to work independently, manage field visits efficiently, and close deals under pressure., • Highly organized with solid time management, project coordination, and problem-solving abilities., • 寻找并招募潜在的商户（如餐厅、门店等）入驻平台，向其介绍公司的产品和服务，促成合作关系的建立；, • 频繁前往目标区域的商户进行面对面洽谈，推动合作意向，谈判合作协议，并完成入驻流程；, • 通过定期拜访、日常支持和问题解决，与商户建立并维护长期稳定的合作关系；, • 针对已入驻商户制定个性化平台运营策略，协助其优化平台表现，提升订单量和销售额（GMV）；, • 与市场团队协作，为商户策划推广活动或增值服务，提升品牌曝光与交易频次；, • 持续更新和管理商户后台设置，确保操作顺畅、信息准确，并可追踪业绩表现；, • 中文流利，能基本使用英文沟通者优先；, • 有B2B销售、商户拓展或线下BD相关经验者优先；, • 熟悉本地生活服务、餐饮外卖、电商平台运营者优先考虑；, • 具备出色的人际交往和谈判能力，擅长与商户建立信任关系；, • 能独立工作，高效完成拜访及签约任务，并能承受一定工作压力；, • 具备良好的时间管理、项目协调和问题解决能力； Pay: $40,000.00 - $60,000.00 per year Powered by JazzHR G2H6pca7p7

Job DescriptionCompany Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description Statistical Science Director provide highly experienced statistical, scientific and strategic support to the clinical and regulatory strategies across all phases of drug development, in-licensing opportunities, pre-clinical development, marketing activities, other specialized areas and/or line functions (e.g. drug safety, clinical pharm) to maximize the benefit-risk of Sobi products. The Statistical Science Director is typically taking the role as the Product Statistician. The Product Statistician: • is accountable for the overall quality and the timely delivery of the statistical analyses for the assigned products, • is accountable for all statistical aspects within assigned products providing statistical, scientific and strategic expertise to quantify the benefit-risk value and uncertainty of the emerging product profile throughout all phases of the drug development process in compliance with Sobi SOPs and regulatory requirements/guidelines., • is accountable for leading the statistical thinking and contributions to the creation and development of TPP/TPC, Target Label and Clinical Development Plans as well as to the Regulatory and Commercial Strategies for Sobi products., • provides leadership and project coordination to all statisticians working in the project, including in-house consultants and statisticians at CROs, • is accountable for the statistical content in the CSP and CSR The Statistical Science Director is qualified for membership of the Study Document Review Forum (SDRF) and may also participate in in-licensing projects or work in other roles as appropriate. The Statistical Science Director is responsible for coaching and developing less experienced statisticians. • Provide leadership and project coordination to all statisticians working in the project, including in-house consultants and statisticians at CRO, • Provide statistical and strategic input into the establishment of a focused, aligned and achievable Target Product Profile (TPP) and Target Labels, • Provide statistical and strategic input into the design and preparation of the Clinical Development Plan (CDP) ensuring alignment with the TPPs and Target Label, • Provide statistical and strategic input to relevant documents in regulatory submissions, e.g. eCTD, • Take a pro-active role in designing innovative studies and programs, including Go/No Go criterion and associated risk levels, to meet project objectives and regulatory requirements, • Approve and sign CSPs, including the statistical content, • Approve Statistical Analysis Plans for studies and regulatory submissions, • Approve and sign CSRs, including the statistical analysis and clinical interpretation of study data, • Participate in preparing responses to regulatory questions, • Provide statistical and strategic input into other regulatory documentation, e.g. CSP, CSR, IB, PSUR and RMP, • Participate in developing the publication strategy as a member of the publication team, • Contribute to the writing of publications and abstracts, in accordance with the publication strategy for the project, as applicable, • Ensure high quality statistical support for projects through the evaluation of CRO suppliers, and provide input into outsourcing strategy and processes, • Collaborate with internal statisticians to drive best practices and implement new initiatives, • Stay informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings., • Contribute to the development of SOPs as relevant Qualifications Education/Learning Experience Required: Bachelor of Science (BSc) in mathematical statistics, statistics or equivalent. Desired: Master of Science (MSc) or PhD in mathematical statistics, statistics or equivalent Work Experience Required: • 8 years of experience as a statistician in the pharmaceutical industry, • Previous leadership experience from project and/or line management, • Extensive experience working in phase II, III and IV programs and/or studies, • Extensive experience of clinical program and study design and data analysis in using a variety of designs and complex statistical techniques, with different types of data and issues, • Experience of major regulatory submissions and/or previous attendance at meetings with regulatory authorities Desired: • Experience working in all phases of clinical development, • Extensive experience of regulatory submissions and previous attendance at meetings with regulatory authorities in more than one region, e.g. Europe, US, Japan, and China, • Experience of collaboration with statisticians and other functions at CROs around out-sourced clinical studies Skills/Knowledge Required: • Comprehensive knowledge of clinical and pharmaceutical drug development, • Sound knowledge of theoretical and applied statistics, • Ability to find innovative approaches to trial design and analysis, • Sound understanding of the regulatory environment within clinical development, • Ability to be the statistical representative from the company at regulatory interactions, • Ability to coach less experienced statisticians in all aspects of their role. Personal Attributes Required: • Excellent written and oral communication skills, • Strategic thinking and influencing skills, • Ability to communicate statistical information to non-statisticians, • Strong ability to collaborate and contribute in global cross-functional teams, • Leadership skills Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: • A competitive 401(k) match to support your financial future., • Tuition and wellness reimbursements to invest in your personal and professional growth., • A comprehensive medical, dental, and vision package to prioritize your health and well-being. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to Know Your Rights