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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. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Director, Quantitative Clinical Pharmacology (QCP) Lead in our Cambridge, MA office. Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences, and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each 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 Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project. • Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Has primary responsibility for dosage selection and generation of causality evidence., • Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure, and best practice initiatives., • Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines., • Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data and Quantitative Sciences (DQS) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications. ACCOUNTABILITIES: • Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams., • Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK)., • Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions., • Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions., • Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DQS and external partners., • Maintains a high standard for good clinical practice, compliance, and ethics., • Mentors junior staff to promote scientific excellence and individual achievement., • Participates as a member of Business Development due diligence, when requested., • Contributes to infrastructure initiatives and/ or cross-functional best practice initiatives., • Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education & Experience • Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD, • MS with 12+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD, • Preference will be given to candidates with experience in oncology drug development. Technical skills: • Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies., • Formulates and executes clinical pharmacology plans including integration of MIDD principles., • Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs., • Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA, EMA and others)., • Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making., • Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics., • Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy. Behavioral competencies: • Independently works by delivering, and prioritizing QCP activities across projects with minimal supervision., • Effectively drives and influences project teams towards objectives while enabling and making decisions., • Focuses on priorities and delivers on commitments., • Strong communication skills and ability to translate effectively across functional lines., • Possess collaborative mindset, inspire teamwork, and is effective at building alliance across functions., • Assess benefit/risk of options., • Develop understanding of business beyond QCP/Pharmacometrics. This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-JV2 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Cambridge, MA U.S. Base Salary Range: $174,500.00 - $274,230.00 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. Cambridge, MA Employee Regular 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. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Vice President , Global Clinical Lead - 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: Responsible for leading as the Global Clinical Lead a large solid tumor oncology franchise that encompass multiple late stage and early phase programs . Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate governance committees. Oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP). Responsible for review of synopses, other relevant clinical study documents and critical Study Results. Provide leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads. Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area. ACCOUNTABILITIES: • Clinical Development team participation and leadership, • Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies., • Consistent with the Takeda R&D Oncology Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regions, • Part of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group, • Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the 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: 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., • Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed., • Providing strategic input into global development strategies and plans for all compounds in OTAU., • Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities), • Primary interface with Medical Affairs team for strategy and to support of product commercial efforts, • Contributing to the creation and maintenance of regional KOL network, • Providing recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts, • Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation, • Synopsis / Protocol Development, Study Execution, & Study Interpretation, • Consistent with membership of the Clinical Review Board Committee, responsible for critical review of synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds., • Trial Medical Monitoring, • Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds., • External Interactions, • Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds., • Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment., • Proactive identification of challenges and development of contingency plans as appropriate., • Due Diligence, Business Development and Alliance Projects, • Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment., • Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities., • 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., • Assigns and manages clinical science staff who are involved in many of these activities., • Leadership, Task Force Participation, Upper Management Accountability, • Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area. Leads TGRD internal teams and global cross-functional teams. Works with functional leadership to prioritize projects within the therapeutic area., • 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: Experience • MD or combined MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including minimum 10 years late phase clinical development experience with a focus on medical oncology, • Clinical Training and Clinical Experience in Hematology/Oncology and/or Medical Oncology especially in solid tumor malignancies, • Strong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapies., • Experience in conducting and/ or leading multiple clinical trials involving immune based therapies, • Proven experience in successfully leading and supervising direct reports including several physicians, physician scientists, scientists within a clinical development team in a global matrix environment., • Demonstrated ability to foster a high-performance culture and build organizational capabilities., • Strong leadership commitment to diversity, equity and inclusion, with experience in creating an inclusive and collaborative team environment that leverages diverse perspectives., • Previous experience in successfully leading several clinical development team/matrix team with responsibility for Global studies in multiple regions. Clinical Development experience beyond US/EU, • Solid and Multiple experience in preparing and interacting with multiple regulatory agencies including FDA, EMA, and others, • Multiple NDA/MAA submission experience, • Proven ability to lead and manage highly trained medical, scientific, and technical professionals., • Superior communication, strategic, interpersonal and negotiating skills, • Enterprise level leadership with the ability to inspire, motivate and drive results, • Excellent communication both verbally and in writing 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 across multinational business cultures TRAVEL REQUIREMENTS: • Willingness to travel to various meetings or client sites, including overnight trips. Several international travels may be required., • Requires approximately 25-35 % 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 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 This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. #LI-JT1 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: $307,300.00 - $482,900.00 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. Boston, MA Employee Regular 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. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project. * Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Possesses primary responsibility for dosage selection and generation of causality evidence. * Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives. * Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines. * Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications. POSITION ACCOUNTABILITIES: * Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams. * Be charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum. * Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK). * Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions. * Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions. * Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DSI and external partners. * Maintains a high standard for good clinical practice, compliance, and ethics. * Mentors junior staff to promote scientific excellence and individual achievement. * Participates as a member of Business Development due diligence, when requested. * Contributes to infrastructure initiatives and/ or cross-functional best practice initiatives. * Has scientific influence outside QCP and Takeda through presentations and publications and active contribution to scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: * Pharm D. or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD * MS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD Technical Skills: * Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies. * Formulates and executes clinical pharmacology plans including integration of MIDD principles. * Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. * Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across different regions (ICH, FDA, EMA and others). * Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making. * Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics. * Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy. This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-JV2 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $153,600.00 - $241,340.00 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. Boston, MA Employee Regular 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.

Job Description Clinical Psychologist – Veteran Disability Assessments We are seeking a dedicated Clinical Psychologist to join our team in performing medical assessments for U.S. Veterans as part of the VA's disability benefits process. In performing Disability Assessments, you will review behavioral health records electronically through a secure Web Portal and perform a comprehensive assessment in-person on each Veteran. Key Responsibilities: • Conduct in-person disability assessments for U.S. Veterans., • Review and analyze electronic medical records via a secure web portal. Position Details: • Schedule: Part-Time (Monday-Wednesday 9AM-5PM)., • Location: In-person role., • Caseload: 4 Veterans per day on average., • Equipment Provided: Computer and all necessary tools for documentation. What We’re Looking For: • A compassionate Psychologist dedicated to supporting the Veteran community., • Strong analytical skills to review medical records and assessment data., • Excellent time management and ability to meet deadlines., • Proficient in electronic documentation and web-based portals., • A professional and empathetic demeanor when interacting with Veterans. Requirements: • Has a Ph.D. or Psy.D and has graduated from an APA Accredited program/school., • Holds an active & unrestricted Psychology license., • Comfortable using technology to review records and complete documentation. Compensation & Benefits: • Competitive salary (based on experience)., • Health insurance & 401K benefits available., • Malpractice Insurance covered by MRG., • Training and ongoing support provided., • Predictable schedule with no on-call duties. Is This Role Right for You? • Do you find it rewarding to serve and support Veterans?, • Are you looking for a structured role with no on-call shifts?

Inizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses. A successful candidate will be able to show documented success as a top producer while effectively managing their territory as a results-oriented salesperson, business partner and consultant. The incumbent will skillfully deal with the concepts and complexities associated with the product and must demonstrate an in-depth understanding of the clinical data. This is your opportunity to join Inizio Engage and represent a top biotechnology company! What’s in it for you? • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotion, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? • Meet or exceed all established territory sales plan and objectives, by developing and implementing strategies specific to the assigned territory., • Establish and maintain professional relationships with targeted opinion leaders and physicians, • Effectively plan workdays and sales calls to accomplish activity goals and objectives., • Develop and implement special programs within territory to maximize sales opportunities, i.e., speakers' bureau programs, symposia, etc., • Complete assigned administrative tasks in a timely, accurate, legible, and organized manner., • Communicate a current, effective, and accurate sales presentation to customers., • Present a professional sales image in all business matters., • Carry out duties and responsibilities in compliance with applicable regulations and Pharma guidelines and operate assigned sales territory within established sales and/or corporate policies, procedures, and standards., • Attend regional and national conferences throughout the year. What do you need for this position? • Bachelor's Degree required, • 2+ years business or customer service experience; sales preferred, • Pharmaceutical Sales highly preferred, • Men's Health preferred, • Proven time-management skills, • Strong interpersonal and relationship building skills, • Strong work ethic and drive to succeed in all situations, • Positive attitude and growth mindset, • A sense of resourcefulness and ability to overcome challenges/obstacles when working in a new territory, • Excellent communication skills, • Ability/willingness to travel extensively and stay at a location for an extended period of time. Local and potential overnight travel is required, • Valid driver’s license and clean driving record About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The Role The Medical Science Liaison (MSL/Sr. MSL) of US Medical Affairs Solid Tumor Head & Neck Cancers will report to the Regional Director MSLs, US Medical Affairs Solid Tumor Head & Neck Cancer. S/he will be a member of a field-based team within the Solid Tumor Head & Neck Cancer-focused organization. The MSL/Sr. MSL is responsible for developing and enhancing professional relationships with medical thought leaders to support both Genmab approved products and those in various phases of clinical development. S/he provides scientific and clinical information through fair-balanced scientific exchange and supports new product launch excellence. The MSL/Sr. MSL executes field medical activities, collaborating with cross-functional field team members to ensure differentiated customer experience and optimal patient outcomes. Domestic Travel of approximately 50% will be required. The territory will be Northeast (ME, VT, NH, MA, RI, CT, Eastern NY). Responsibilities * Identify key thought leaders and establish, foster, cultivate, and maintain relationships with healthcare providers (HCPs) in academic and community centers within assigned territory * Develop and execute territory plans in alignment with regional and national (US) Medical Affairs strategies * Provide insights/feedback on emerging scientific/clinical data that enhance the value and appropriate use of Genmab products as part of compliant collaboration with internal stakeholders * Present appropriate clinical and scientific information to healthcare providers in response to unsolicited requests (as appropriate) in a fair and balanced manner * Provide medical and scientific education related to disease state and Genmab products to healthcare providers * Support product launches through HCP education for safe use of our medicines * Act as the primary point of contact and facilitator for all aspects of investigator sponsored trials (ISTs), from submission, review and approval, through study activation/completion * Collaborate effectively and proactively establish working relationships with cross-functional teams * In collaboration with medical and clinical operations teams, drive engagement of HCPs involved in Genmab-sponsored trials * Maintain up-to-date knowledge of products, clinical treatment trends, clinical trials, and scientific activities within the focused areas of interest for the head and neck cancer team * Serve as a scientific resource to commercial partners, as appropriate, to support pre- peri-, and post-launch activities * Support the execution, organization, and planning of advisory boards * Professionally represent Genmab at select medical and scientific conferences and meetings Requirements * Advanced degree in health-related field (PharmD, PhD, or MD) strongly preferred. Candidates with clinical background (e.g., NP, PA, etc.) and extensive oncology MSL experience will be considered. * At least 2 years of MSL/Medical Affairs experience in Oncology/Solid Tumor focus preferred * Strong knowledge and/or experience of healthcare and access environments * Proven ability to work independently, as well as cross-functionally with numerous internal stakeholders in a highly matrixed environment * Preferred experience on product launches or demonstrated success as product or therapeutic point * Excellent interpersonal communication and presentation skills, strong personal integrity, teamwork abilities, and a customer focus are necessary * Must be able to organize, prioritize, and work effectively in a constantly changing environment * Strong compliance knowledge and adherence to corporate compliance policies * Current working knowledge of FDA, OIG, ICH, GCP, PhRMA Code, HIPAA and other compliance regulations and guidelines relevant to industry interactions with healthcare professionals * Demonstrated technical acumen including MS Office skills, ability to adopt and leverage multiple business applications For US based candidates, the proposed salary band for this position is as follows: $144,720.00---$217,080.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: * 401(k) Plan: 100% match on the first 6% of contributions * Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance * Voluntary Plans: Critical illness, accident, and hospital indemnity insurance * Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave * Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support * Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You * You are genuinely passionate about our purpose * You bring precision and excellence to all that you do * You believe in our rooted-in-science approach to problem-solving * You are a generous collaborator who can work in teams with a broad spectrum of backgrounds * You take pride in enabling the best work of others on the team * You can grapple with the unknown and be innovative * You have experience working in a fast-growing, dynamic company (or a strong desire to) * You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on ___ and ___. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website ___. Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Inizio Engage has a long-standing partnership with a leading biotechnology organization across Commercial, Patient Solutions and Medical Affairs businesses. We are seeking a Clinical Educator to deliver educational support to identified Healthcare Professionals and office staff within primary care and specialist facilities in the field of a designated disease state. The Clinical Educator will provide disease state education, related resources, and approved product education in accordance with program standards and compliance guidelines, while meeting all relevant expectations set by Inizio leadership. This is your opportunity to join Inizio Engage and represent a top biotechnology organization! What’s in it for you? • Competitive compensation, • Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions, • Employee discounts & exclusive promotions, • Recognition programs, contests, and company-wide awards, • Exceptional, collaborative culture, • Best Places to Work in BioPharma (2022, 2023, & 2024), • Certified Great Place to Work (2022, 2023, 2025) What will you be doing? • Provide disease state education, awareness, and approved resources to identified Healthcare Professionals and office staff as agreed by Inizio leadership, • Present educational programs, both live and virtual, tailored to the needs of each healthcare office, • Increase awareness of disease state through compliant education, • Educate office staff on diagnostic processes, disease state information, and approved product education including safety and adverse event information per label, • Develop and strengthen relationships with key healthcare professionals and office staff, • Identify and support referral pathways across multidisciplinary teams, • Facilitate the development and provision of services across multiple healthcare sectors, • Use only approved materials provided by Inizio. Materials may not be changed, copied, or distributed, • Complete all required training courses and competency assessments within specified timeframes, • Ensure accurate and timely documentation of all office interactions and required reporting activities, • Capture time and expenses through the designated Inizio systems, • Maintain professional registration and/or licensing as required by applicable state laws, • Attend local and national meetings and/or conferences to remain current on program developments and share best practices, • Maintain company equipment and materials in accordance with company instructions, • Comply with all Inizio policies and procedures and all applicable compliance standards, • Be contactable during working hours to respond to inquiries and perform responsibilities, • Possess a full, valid United States driver’s license at all times and notify Inizio immediately of any offenses or accumulation of penalty points, • Effectively manage assigned territory and travel as needed, including overnight travel, • Perform other duties as requested, • Clinical Educators do not provide nursing services, medical or treatment advice, and do not market or promote pharmacological products. What do you need for this position? • Qualified Healthcare Professional with current state license (Respiratory Therapist or Registered Nurse preferred), • Associate’s Degree, Bachelor’s Degree, BSN, or equivalent work-related experience, • Minimum of 3+ years’ experience working in a specific disease state or related field; respiratory experience preferred, • Previous experience in pharmaceutical or biotech industry as a clinical educator or in sales preferred, • Excellent professional communication and presentation skills, • Ability to present to physicians and various members of office staff, • Strong interpersonal and organizational skills, • Demonstrated ability to manage multiple responsibilities and territory priorities, • Self-starter with high personal motivation, • Evidence of continual professional development and commitment to maintaining clinical knowledge, • Willingness to travel up to 75%, including overnight stays, • Ability to lift and carry up to 25 pounds and operate standard office equipment About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Jeffrey Glassman Injury Lawyers is a leading personal injury law firm in Boston, committed to providing exceptional legal representation to our clients. We are dedicated to serving veterans and ensuring they receive the benefits they deserve. Our team is passionate about advocating for those who have served our country and need assistance navigating the complex VA claims process. Job Description: We are seeking a dedicated and compassionate Veterans Disability Attorney to join our team. The ideal candidate will have a strong commitment to serving veterans, excellent legal skills, and a thorough understanding of VA disability law. This role involves representing veterans in disability claims, providing legal advice, and ensuring our clients receive the maximum benefits they are entitled to. Key Responsibilities: • Represent veterans in disability claims before the Department of Veterans Affairs (VA)., • Assist clients in preparing and filing VA disability claims., • Review and analyze medical records and service documents., • Advocate for clients at VA hearings and appeals., • Provide legal advice and support to veterans and their families., • Stay current on VA laws, regulations, and procedures., • Collaborate with medical professionals and other experts to support claims., • Juris Doctor (JD) degree from an accredited law school., • Admitted to practice law and in good standing with the state bar of Massachusetts., • Minimum of 2 years of experience in veterans disability law or related field., • Strong understanding of VA disability benefits and claims process., • Excellent communication and interpersonal skills., • Ability to handle multiple cases and work in a fast-paced environment., • Compassionate and patient demeanor, with a commitment to serving veterans., • Competitive salary and benefits package., • Opportunities for professional growth and development., • Supportive and collaborative work environment., • The chance to make a meaningful impact on the lives of veterans and their families.

Associate Director, Clinical Scientist. Work within a matrix environment, collaborating with medical directors, regulatory affairs, translational medicine, clinical operations, statistics, and other departments to drive clinical development programs forward.

Marketing Cambridge, MA * ID: 26R-17 * Full-Time/Regular This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a flexible, "magnet not mandate" approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs. Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Position Summary: Akebia is seeking a high-impact, mission-driven and collaborative Product Manager to play a key role in executing engaging marketing initiatives that drive adoption and sustained growth of Vafseo. This role will work closely with marketing leaders and cross-functional partners to support HCP and/or patient-facing programs across personal and non-personal channels. The ideal candidate is highly collaborative, performance-driven, and thrives in a fast-paced, dynamic biotech environment. This role reports directly to the Director, Marketing. Job Summary: • Contribute to the development of the marketing plans for Vafseo across personal and non-personal marketing tactics, • Ensure alignment of marketing materials with approved brand campaign and messages, • Execute marketing materials to support HCP and patient communications across personal and non-personal communications (e.g. sales brochures, marketing CRM, etc.), • Execute marketing tactics at national and regional congresses in partnership with the personal promotion lead and meetings management, • Collaborate effectively with Promotional Review Committee (PRC) partners to ensure execution aligns with brand strategy and marketing timelines, • Support additional marketing initiatives and special projects as needed, including brand planning, budget tracking, and other ad hoc assignments to advance business objectives, • Develop and maintain strong relationships with areas outside the marketing team, including sales, commercial operations, medical affairs, regulatory, legal and compliance, • Effectively manage agencies to achieve high quality deliverables within time and budget scopes, • Support the brand team with assistance on process for contracts and procurement, • Contribute to a collaborative, mission-driven culture focused on delivering meaningful outcomes for patients Basic Qualifications • Bachelor's Degree required, • Minimum 3 years of experience in pharmaceutical, biotechnology or healthcare creative agency, • Minimum of 2 years of experience in marketing, communications or PR with experience working with HCP and/or patient marketing in personal or digital channels Preferred Qualifications: • Strong collaboration skills with cross-functional teams, • Proven project management skills and attention to detail including budget and time management, • Experience managing agencies and external vendors, • Strong written and communication skills, • Occasional travel to attend sales meetings and relevant medical congresses within the U.S. Compensation: Targeted Base: $109,547-$135,323 * *Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: ___ Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Director, Medical Affairs Capabilities & Training Location: Boston, MA (Hybrid) or Remote EPM Scientific is partnering with a global biopharmaceutical company dedicated to developing innovative oncology and neurology therapies for patients with high unmet needs, seeking an experienced Director of U.S. Medical Affairs Capabilities & Training. The Director will lead the design and implementation of a comprehensive scientific education curriculum, onboarding programs, and capabilities-based training for both Home-Office and Field-based Medical Affairs professionals. Responsibilities: • Develop and deliver onboarding programs for MSLs and in-house Medical Affairs personnel on relevant therapeutic areas, products, and core capabilities/skills., • Maintain a digital learning platform with self-paced e-learning modules and training resources., • Provide continuing education to the department on clinical data, publications, and competitive landscape., • Regularly align with Medical Affairs leadership on training content, priorities, and strategy., • Define and track performance metrics to assess the effectiveness of educational programs., • Contribute to departmental resource allocation, tactical planning, and long-term strategy., • Manage 1-2 direct reports. Qualifications: • Advanced medical/scientific degree (PhD, MD, PharmD), • 5+ years of experience in Medical Affairs training, learning and development, or capabilities position., • Expertise in oncology is strongly preferred., • Travel nationally/internationally as needed (up to 20-30%). Compensation and Benefits: • Base Salary of $240,000 - $260,000, • 25% annual bonus, • Annually vesting LTI program, • Flexible/unlimited PTO plan, • Generous company-matched 401K contributions, • Health, vision, dental, and short- and long-term disability insurance, • Company-wide winter and summer breaks

To apply: Please send a cover letter and resume to . Applicants who apply solely through LinkedIn will not be considered. About Grove Partners Grove Partners is a strategic campaign firm that helps organizations navigate complex reputational, regulatory, and growth challenges. We work at the intersection of business, government, media, and public opinion—running campaigns designed to win in high-stakes environments. Our clients range from leading universities and Fortune 500 companies to growth-stage startups and mission-driven organizations. Role Overview The Research Associate supports Grove Partners’ campaign and client work through rigorous research, high-quality writing, and day-to-day execution of strategic initiatives. This individual will work closely with senior leadership to translate strategy into action—producing written materials, monitoring policy developments, and supporting stakeholder and grassroots engagement across a diverse portfolio of campaigns. This is a hands-on, fast-paced role suited for a detail-oriented and intellectually curious professional who is eager to contribute meaningfully to high-impact public affairs, communications, and advocacy work. Key Responsibilities: Campaign Execution & Research Support • Support senior team members in executing and implementing campaign strategies and tactics across client engagements., • Monitor and track key policy developments, synthesizing complex information into clear and actionable insights., • Conduct background research to support messaging, stakeholder engagement, and campaign decision-making. Writing & Content Development • Assist in the creation and development of written materials including articles, blog posts, social media content, white papers, case studies, and data-driven reports., • Edit and proofread written materials to ensure accuracy, clarity, and consistency with Grove Partners’ standards., • Help translate complex policy, data, or technical concepts into accessible content for non-technical audiences. Collaboration & Stakeholder Support • Collaborate with internal team members to enhance written content with visuals such as infographics, charts, and design elements., • Support stakeholder and grassroots engagement efforts through research, content development, and follow-through., • Stay attuned to client needs, preferences, and challenges to ensure effective execution of assigned tactics. Required Qualifications • Bachelor’s degree in public policy, English, communications, or a related field., • Proven experience as a writer, researcher, content creator, or in a similar role., • Excellent writing, editing, and proofreading skills with strong attention to detail., • Strong organizational skills, follow-through, and ability to manage multiple priorities simultaneously. Preferred Qualifications • 1-2 years full time experience working on a political campaign or in a public affairs, advocacy, or communications environment., • Familiarity with grassroots engagement, campaign tactics, and storytelling techniques., • Demonstrated creativity and curiosity across a wide range of policy and industry topics. What We Offer • A collaborative, entrepreneurial team environment with direct access to senior leadership., • Base salary of $60,000-$65,000., • Comprehensive benefits package, including: medical and dental insurance, 401(k) retirement plan with employer contribution and vesting, paid time off and holidays., • Flexibility and trust paired with high expectations, accountability, and meaningful responsibility from day one.

Vice President, Clinical Development Small Biotech | Immuno-Oncology | Late-Phase Leadership I’m partnering with an innovative, well-backed small biotech seeking a VP, Clinical Development to lead strategy and execution across a late-stage immuno-oncology portfolio. This is a highly visible executive role with the opportunity to shape overall clinical direction, influence corporate strategy, and work closely with the C-suite and Board. Key Responsibilities: • Define and lead global clinical development strategy across late-phase programs, • Provide executive oversight of Phase II/III trials, including design, execution, and data interpretation, • Drive regulatory strategy and represent the company in health authority interactions, • Partner cross-functionally across regulatory, translational sciences, biometrics, commercial, and medical affairs, • Serve as a key external ambassador with KOLs, investigators, partners, and investors Ideal Profile: • MD required, board-certification in oncology strongly preferred, • Deep immuno-oncology expertise, • HCC (hepatocellular carcinoma) experience strongly preferred, • Proven late-phase (Ph II/III) leadership experience, • Strong track record of regulatory engagement and filings, • Strategic thinker who is equally comfortable being hands-on in a lean biotech environment This is a rare opportunity to step into a true leadership seat where you will directly impact pipeline strategy and patient outcomes in a dynamic, entrepreneurial setting. For a confidential discussion, please reach out:

Job Description Objective / Purpose: Expected to engage others by inspiring commitment. Collaborate by influencing through relationships, mobilize high performance, anticipate the group’s future needs and help develop capabilities aligned with those needs. Champion change and be a role model for junior staff not only in technical expertise but across Takeda competencies. • Independently leads development of strategy and plans for multiple, complex programs, • Regularly leads and influences functional/divisional strategy, operations and innovation, • Functional thought leader and mentor, • Impactful contributor to divisional initiatives and may contribute to corporate, cross-divisional, and global initiatives Accountabilities: Program Leadership: • Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require scientific depth and overall product development acumen for successful execution, • Identifies, mitigates and communicates project or program risks to relevant stakeholders. This person is expected to advance not only the program teams they lead but also other teams that are facing unique challenges., • Lead/participates as functional expert in divisional and cross-divisional initiatives., • Represents CMC on cross-divisional governance and development teams while providing strategy and accountability for CMC deliverables. Technical Acumen: • Provides scientific leadership and innovation in pharmaceutical research and development. Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives., • Mentors other members of the department to develop their abilities to lead and advance their individual skills of pharmaceutical product development. Demonstrates humility and approachability in encouraging others to challenge ideas and openly raise issues., • Acts as an internal consultant to the Pharmaceutical Sciences staff for any scientific advice that may be needed on a project basis., • Develops the capabilities of the department by identifying opportunities and anticipating changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business., • Represents Pharmaceutical Sciences in cross divisional, corporate and global initiatives. Cultivates a broad network of relationships throughout Takeda, with affiliates and alliance partners, in the industry and area of expertise., • Inspires commitment through a wide range of communication channels (meetings, writing, and presentations)., • Develops and communicates convincing business cases for department strategies that motivate stakeholders to take action., • Ensures that technical and scientific standards within the function meet state-of-the-art industry expectations., • Identifies, evaluates, develops, recommends and/or negotiates novel solutions to meet critical project needs., • Critically reviews technical and scientific reports from external sources and coordinates Takeda-sponsored work. Education & Competencies (Technical and Behavioral): Education / Experience: • BS + 18 years of experience; MS + 16 years of experience; PhD + 10 years of experience Technical Skills/Competencies: • Ability to propose and influence development to result in a commercially viable product., • Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions., • Experience must be in a scientific discipline with expert knowledge of pharmaceutical development, including an understanding of current laboratory techniques, instrumentation, problem solving techniques, process engineering and manufacturing development, and statistics used in experimental work. Regularly contributes functional expertise to external industry and advocacy groups., • Must demonstrate knowledge of several allied fields, such as chemical engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs. Advanced understanding in DMPK, Pharmacology and Toxicology., • Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies., • Must have experience in global regulatory submission requirements and processes. Program Leadership Skills/Competencies: Experience with the application of project leadership knowledge, skills, tools, and techniques for complex multidisciplinary programs and initiatives. • Leadership - develops and uses knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program, divisional and corporate goals and objectives; adapts well to different personalities and manages others on the team in a respectful manner., • Risk Management - ability to identify/solve technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies. Ability to identify gaps in CMC technology/trends and influence change/improvements to affected areas/processes., • Communication - ability to expresses one’s self clearly and concisely to key stakeholders; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience. Can represent CMC viewpoint at corporate and industry level., • Resource Management - ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital). 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: $174,500.00 - $274,230.00 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.

Senior Director – Clinical Scientist We are partnering with an exciting early-stage biotech developing innovative therapies in cardiology and renal diseases. This is a strategic leadership role offering above-market compensation and the chance to shape clinical programs from the ground up. Key Responsibilities: • Lead clinical science strategy for early-stage programs, collaborating closely with R&D, translational medicine, and Medical Affairs., • Design and oversee clinical studies, protocol development, and scientific documentation., • Engage with KOLs, academic collaborators, and external experts to guide program direction., • Translate scientific insights into actionable strategies for clinical development., • Advanced degree (MD, PhD, PharmD) with strong clinical or research experience in cardiology or nephrology., • Experience in early-stage biotech or translational research is highly preferred., • Proven leadership in clinical strategy, medical affairs, or clinical operations., • Direct impact on developing breakthrough therapies from early stages., • Strategic leadership role in a nimble, innovative biotech environment., • Competitive, above-market compensation and growth potential. Next Steps: If you’re an experienced clinical scientist eager to shape early-stage programs, share your availability to discuss this opportunity.

Director, Global HEOR [ RETAINED SEARCH ] • Top Boston Commercial-Stage Pharma, • focus on high-profile, clinical-stage, rare disease biologic with multiple indications Cornerstone Search Group’s HEOR/Market Access Practice is pleased to be retained once again by a leading Boston-area pharmaceutical company renowned for operating at the forefront of scientific innovation, successfully launching multiple breakthrough medicines, and having top-notch talent. They are seeking a technically strong HEOR professional with very good communication skills for a newly created and critical Global HEOR position that will focus on a high-profile, first-in-class potential, clinical-stage biologic asset projected to be a multi-blockbuster with multiple and diverse immunology-related rare disease indications. 5 Highly Attractive Features: • High-Profile Impact: This newly created, highly visible role focuses on a clinical-stage biologic that is potentially first-in-class, has multiple and diverse rare disease indication approval potential, and is anticipated to be a multi-blockbuster., • Stable and Growing Company: In an era of instability and staff cutbacks by companies of all sizes, our client’s scientific and strategic acumen has led to continued growth, providing organizational stability and demonstrated career progression for multiple HEOR professionals., • Strong HEOR Leadership: Our client’s HEOR department has steady, proven, high-EQ leadership whom we know quite well., • Attractive to Directors: Our client offers highly competitive compensation, LTI, relocation, and sign-on bonus programs along with a highly regarded department leader and a demonstrated history of internal career growth. This position can thus be very attractive to experienced HEOR Directors., • Opportunity to Gain Global Experience: Our client is willing to consider a high-potential individual who does not yet have strong global experience as the hiring manager has such experience and is a willing mentor. Key Accountabilities: • Develop HEOR strategy for multiple immunology / auto-immune indications ranging from early development through product lifecycle., • Work with cross-functional and cross-regional teams to align strategic plans., • Gather and synthesize insights from Payers and KOLs., • Plan, design, and execute HEOR evidence generation including observational studies (prospective and retroactive), CEA and BIM, ITCs, meta-analyses and systematic reviews, and COA/PRO., • Supports the integration of HEOR evidence in HTA submissions., • Collaborates cross-functionally on publication strategy and HEOR evidence dissemination., • Partner closely with your global pricing and global market access colleagues to support production of global value dossier. Location: Boston Metro Area - 3 days per week on-site is required Relocation: Full relocation assistance is available. Compensation: Highly competitive base and bonus along with aggressive LTI program, generous PTO, and excellent benefits. Desired Skills/ Qualifications / Experiences / Behaviors: • MA/MS, MPH, PharmD, PhD, or MD, • 5+ years of relevant experience, • Strategic and analytical thinker who can connect clinical-stage evidence generation activities to business and clinical priorities. A hands-on project leader with strong execution skills and attention to detail., • A track record of formulating and leading creative and scientifically rigorous research projects., • Technical strengths in data analytics, database research, RWE, and outcomes research., • Experience preparing publications and presenting scientific findings., • Our client does not require therapeutic areas of experience., • High EQ (emotional intelligence) coupled with persuasive communication, presentation, and influencing skills across internal and external stakeholders. CONTACT: Rita Boyle | Partner 973.656.0220 x735 or Corey S. Ackerman, JD | Senior Partner 973.656.0220 x716 CORNERSTONE SEARCH GROUP - Life Sciences Executive Search 1200 Morris Turnpike, Suite 3005 | Short Hills, NJ (USA) Cornerstone Search Group, recognized by Forbes as one of the "Top 100 Executive Search Firms" and by Hunt Scanlon as one of the "Top 50 Healthcare & Life Sciences Executive Search Firms", is a Life Sciences Executive Search firm that helps companies based around the world, ranging from startup biotechs to Top 10 pharma, to find, attract, and hire talent for their US and globally based leadership positions (CxO and xVP levels) as well as their critical Director-level roles. Representative Retained Search Assignments: • CEO | specialty pharma start-up, • CEO | regenerative medicine start-up, • US CEO | established European small pharma, • President/US Commercial Head | Generics Pharma, • CMO | late-stage public biotech, • CMO | mid-size pharma, • CSO | mid-size global biotech, • SVP, Head of Global Medical Affairs | mid-size oncology company, • SVP, Head of Global Clinical Development | multi-TA mid-size pharma, • SVP, Head of Global Regulatory Affairs | late-stage Israeli biotech, • Global Head, Oncology R&D | mid-size European pharma, • Group VP, Global Commercial Head | API Business Unit | Indian pharma, • VP, Data Science RWE | Top 5 Pharma, • VP, Head of Regulatory Affairs | Boston Biotech, • VP, US Head of Regulatory Affairs | Top 20 Pharma, • VP, Head of R&D Operations | Boston biotech, • VP, Head of HEOR (Health Economics & Outcomes Research | Top CNS specialty pharma, • VP, Head of US HEOR & RWE | Top 5 Pharma, • VP, Head of Real-World Evidence | Top 5 pharma, • VP, Head of US HEOR | Top Oncology Pharma, • ED, Head of HEOR | Top West Coast Pharma, • VP, Head of Global Market Access | Top Oncology Specialty Pharma, • VP, Head of US Market Access | High-profile late-stage biotech, • VP, Head of US Market Access | West Coast Late-Stage Public Biotech, • VP, Head of Heme/Onc Clinical Research | Public oncology biotech, • VP, Head of Clinical Development | late-stage anti-infectives UK pharma, • VP, Head of Global Drug Safety & PV | Chinese oncology biotech, • ED, Head of Clinical Operations | British VC-backed biotech, • ED, Global Commercial Strategy Franchise Head | Top rare disease Boston pharma, • ED, Head of Global Clinical Pharmacology | Public oncology biotech, • ED, Head of Global HEOR | Large US Pharma, • Head, Patient Advocacy | European commercial-stage rare disease biotech, • Medical Directors (Director/SD/ED levels) in Translational Medicine / Clinical Development / Medical Affairs / Drug Safety: 75+ retained assignments, • HEOR/RWE/Market Access (AD/Director/SD/ED levels): 100+ retained assignments Cornerstone’s Privacy Policy: Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not be shared with any parties outside of Cornerstone Search Group without your prior permission. Keywords: GHEOR “Health Economics” “Real-World Evidence” RWE ITC “indirect treatment comparison” “rare disease” HEOR GHE HE&OR “HE & OR” “Health Outcomes”

• The Medical Grants and Sponsorship Specialist provides operational support for the review, coordination, and administration of educational grants and sponsorship programs. This role helps manage grant submissions, coordinate communications with applicants and internal stakeholders, track agreements and payments, and support reporting and operational analysis., • The Manager will also assist in developing medical education and external sponsorship strategies and goals in close collaboration with the Therapeutic Area (TA) medical strategy team, including Medical Directors, the External Engagement Lead, and Ethics & Compliance. Minimum Requirements/Qualifications • Bachelor’s degree in a health science–related field required., • Experience with corporate giving, educational grants, or sponsorship programs., • 2+ years of experience in Medical Affairs, medical education, educational granting, or related pharmaceutical industry functions., • Knowledge of legal and regulatory guidelines related to independent medical education, pharmaceutical industry standards, and publication guidelines., • Experience tracking and managing budgets.

Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio. This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. • Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects., • Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations., • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy., • Participates in cross-functional initiatives within Global Regulatory Affairs and Takeda R&D. How you will contribute: • The Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible., • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner., • Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions., • Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs., • Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed., • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products., • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope., • Participates with influence in departmental and cross-functional task-forces and initiatives., • Lead regulatory reviewer in due diligence for licensing opportunities., • Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable., • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner., • Responsible for demonstrating Takeda leadership behaviors Minimum Requirements/Qualifications: • BSc Degree, preferred. BA accepted., • 10+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience., • Preferred experience in reviewing, authoring, or managing components of regulatory submissions., • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus., • Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy., • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy., • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability., • Demonstrates 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 creative solutions and strategies, including risk mitigation strategies., • Must work well with others and within global teams., • 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-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: $174,500.00 - $274,230.00 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.

Overview Our client is a clinical-stage biotechnology company developing innovative therapies across multiple therapeutic areas, including cardiometabolic and hepatology indications. They are seeking a Director, Clinical Development to provide clinical leadership across programs from early development through regulatory approval. Position Summary The Director, Clinical Development will lead the design, planning, and execution of clinical programs while ensuring scientific integrity and medical oversight across all phases of development. This individual will collaborate cross-functionally with Clinical Operations, Regulatory, Pharmacovigilance, Biostatistics, Medical Affairs, and other key stakeholders to drive program strategy and execution. Key Responsibilities • Provide clinical leadership for assigned development programs, • Design and oversee clinical studies across all phases of development, • Serve as medical monitor and subject matter expert as needed, • Collaborate cross-functionally to ensure aligned strategy and execution, • Review and interpret clinical data and contribute to study reports and publications, • Support regulatory interactions and submissions (e.g., IND, NDA/BLA), • Present data at scientific meetings and regulatory forums, • Build relationships with investigators, KOLs, and external partners, • Support clinical strategy, budgeting, and program planning, • Ensure compliance with regulatory requirements and GCP standards Qualifications • MD required (Board certification preferred), • 5+ years of industry or combined academic/industry experience, • Experience across all phases of clinical development, • Strong cross-functional leadership and communication skills, • Knowledge of FDA regulations, ICH/GCP, and clinical trial operations, • Experience in cardiometabolic and/or hepatology preferred Key Skills • Strong scientific and clinical background, • Strategic thinking and problem-solving abilities, • Project leadership and stakeholder management, • Excellent communication and presentation skills, • Familiarity with clinical pharmacology, biostatistics, and regulatory requirements

Pride Health is seeking an Regulatory Affairs Consultant for a biotechnology company specializing in the discovery, development, and delivery of the treatment of neurological diseases to patients worldwide. Job Title: Regulatory Affairs CMC Consultant Location: Remote or hybrid (Cambridge, MA or RTP) Job Type: Contract Duration: 6-Months Hours: 40 hours/wk, 8 hours/day Pay Rate: $70.00 - $83.00 per hour Description: • This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products., • Responsibilities include preparation and compilation of submission/documentation for specific projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as delegated., • Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early stage development programs or working with the Regulatory CMC Lead for late stage development or commercial programs., • The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities, as delegated., • Providing strategic and operational Regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives., • Preparation and delivery of CMC Regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (including IND/IMPD/CTAs/MAAs), • Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities., • Writing and / or Review of regional and global CMC submission documents and responses to Health Authority questions, • Managing CMC aspects of routine and non-routine Health Authority interactions including issue resolution and negotiation of approvals, as delegated., • Monitoring changes in the Regulatory CMC environment to support and advise key stakeholders and teams., • Providing input into Regulatory CMC risks assessment and mitigation plans and ensuring that it remains in line with the overall global Regulatory CMC strategy., • Coordinating and completing regulatory assessments of CMC changes in the designated systems, • Responsible for assuming responsibilities from the Team Lead or Global Regulatory CMC lead, as agreed and delegated and maintaining open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions., • Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of Regulatory CMC on cross functional work streams, • Responsible for leading or assisting in delivery of Regulatory CMC initiatives and the development of Regulatory CMC standards and SOPs, as assigned., • Ensure that appropriate records are maintained in the designated system for submission in assigned regions Additional Job Details: Regulatory skills • At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field., • Successful authoring and contribution to delivering CMC submission documents of development and/or marketed products (biological, oligonucleotide, and/or chemical entities), • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and/or post-approval products, • Experience of direct communication and negotiation with regulatory agencies on CMC matters, • Knowledge of GMP requirements and standard systems (e.g. change management systems), • Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure Leadership/Management Skills, • Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones., • Ability to influence cross-functional stakeholders to ensure execution of optimal RegCMC strategy, • Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities., • Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively., • Demonstrated competency in operations, planning, project management and tracking projects of high complexity and risk with clearly defined critical paths., • Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures., • Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties. Benefits that Pride Health offers: Pride Health offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors. Apply Today! If you are interested in the position, please email your resume to for immediate consideration.

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 Patient Advocacy & Government Affairs Intern will support Ardelyx's corporate presence and relationshipbuilding efforts by helping to plan and execute a policy roundtable event that brings together state policymakers and advocates in addition to assisting with advocacy campaigns with internal and external stakeholders to elevate the voice of patients with IBS-C and CKD Reporting to the Patient Advocacy and Government Affairs team in Waltham, the intern will work on communications, event logistics, and stakeholder engagement activities that are central to the company's government affairs and patient advocacy strategies. Key Responsibilities: • Draft invitations, outreach emails, and other communication materials for policymakers, staff, and advocacy organizations and internal stakeholders., • Develop talking points and key messages for internal leaders and speakers participating in the roundtable., • Assist with scheduling and attending meetings with state legislators, staff, and advocates to discuss event objectives and logistics., • Help secure and coordinate meeting space (either at Ardelyx or an external venue), including room setup needs and on-site logistics., • Draft social media messaging and internal communications to promote the event and highlight Ardelyx's engagement., • Manage event materials, including briefing documents, agendas, handouts, and any leave behind resources., • Track RSVPs, maintain attendee lists, and support day of event execution (check in, logistics, troubleshooting)., • Assist with post event follow up, including thank you communications and basic summary notes or readouts., • Meet with internal and external stakeholders, including patients, caregivers, patient organizations and community members to better understand the impact of CKD and IBS-C on quality of life, mental wellbeing, and daily management., • Draft campaign plans for IBS-C awareness project in IBS-C and assist with logistics of project, including participant tracking, email blasts, platform set up and communications., • Successful planning and execution of a roundtable that brings together policymakers and advocates and strengthens Ardelyx's visibility., • Clear, professional communication materials (invitations, talking points, social posts, and event collateral) that support Patient Advocacy & Government Affairs objectives., • Successful planning and execution of a virtual GI awareness project with internal and external stakeholders that elevates the voice of patients and highlights the dedication of Ardelyx to patients and their families., • Stronger relationships and a more robust community of advocates to support Ardelyx's long term government affairs strategy.Qualifications:, • Currently pursuing a degree in Public Policy, Political Science, Public Health, Communications, or a related field., • Strong written and verbal communication skills, with the ability to draft professional outreach and talking points., • Interest in patient advocacy, health policy, and/or government affairs., • Highly organized, detail oriented, and comfortable managing multiple tasks and deadlines., • Desire to learn, open to constructive mentoring and feedback. Good sense of humor and desire to serve others.Preferred Skills:, • Prior experience with event planning, advocacy, or community engagement is a plus., • Familiarity with state government or legislative processes is helpful but not required., • Hands on experience in patient advocacy and government affairs within a biopharmaceutical context., • Direct exposure to relationship building with policymakers and advocates, including observing and participating in meetings and events., • Practical skills in event planning, stakeholder communications, and policy focused messaging that can be applied to future roles in advocacy, policy, or public affairs.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.

Inizio Engage has partnered with Tonix Pharmaceuticals and are seeking performance-driven, competitive, highly entrepreneurial, and analytical Regional Sales Manager who are willing to put forth discretionary effort to ensure their region meets and exceeds expectations. This is a highly innovative role requiring you to lead by example to drive district performance, think outside of the box, and continually challenge your team to go the extra mile. This is your opportunity to join Inizio Engage and be part of an exciting opportunity to represent a leading biotechnology company preparing for an upcoming launch in the fibromyalgia space! What’s in it for you? * Competitive compensation * Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, paid maternity and paternity leave benefits, employee discounts/promotions * Employee discounts & exclusive promotions * Recognition programs, contests, and company-wide awards * Exceptional, collaborative culture * Best Places to Work in BioPharma (2022, 2023, & 2024) * Certified Great Place to Work (2022, 2023, 2025) What will you be doing? * Ensure that the given geography meets or exceeds all sales targets and goals * Recruit, hire, manage, and develop/coach a high performing team * Create and drive region strategy and short-term tactics to achieve business goals in a timely manner * Execute Consistent and Frequent Performance Management with Sales Team * Work in the field with sales representatives to coach and counsel on improvement of selling skills, product knowledge, and capabilities needed for successful representative development and maximum goal achievement * Monitor data analytics information (sales trends, activity, market share) continuously to ensure full utilization of available resources and tools for maximum impact on prescribing providers while constantly looking for opportunities to improve * Set a positive tone and high standard for the regional team in terms of work ethic, culture, expectations, business ethics * Assess competitive threats, best practices and field learnings and share as appropriate. * Aid in the design of business plans, employee development plans, monthly reports as required * Organize, participate in employee training, conferences, and regional meetings * Collaborate with Market Access and Patient Access on a regular basis. * Collaborate with Medical Affairs as appropriate * Drive call plan adherence and execution * Communicate with Tonix key sales leadership regularly (written and verbal) * Maintain compliance standards What do you need for this position? * Bachelor’s degree in business, science, or related field or equivalent work experience * Ability to influence team member activities * At least 3 years of sales management experience within the Pharmaceutical, Biotechnology or Healthcare Industry is required with proven ability to develop and motivate others, lead through change, and deliver on set objectives. * Product launch experience highly preferred * Rheumatology and/or CNS experience preferred * CSO field management experience plus * Ability to recruit, retain, and develop a high-quality team * A deep understanding of the pharmaceutical and healthcare industries * Greater than 50% travel including overnights with be required About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company; however, only qualified candidates will be considered.

Boston Based Director of Medical Affairs Blackfield Associates are supporting a mid-sized global pharmaceutical company on the hire of a Director of Medical Affairs. This opportunity will be ideal for an experienced MSL to transition into their first head office medical affairs role. You will be tasked with identifying US Key Opinion Leaders and to nurture the relationships through credible scientific engagement. Supporting medical training to commercial colleagues will also play a significant role in this opportunity. For more information, please apply or email

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. Summary: Apellis Safety & Benefit-Risk (SaBR) is responsible for all aspects of patient safety, including single case and aggregate safety monitoring, safety reporting, benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and compliance with global regulatory requirements. Reporting to the Head of SaBR, the Senior Director, Medical Safety Science serves as a senior leader accountable for the strategic direction, operational excellence, and organizational leadership of the Medical Safety Science (MSS) function. This individual will lead a team of Safety Physicians and PV Scientists and serve as a key decision-maker across the company's pipeline and marketed products. The ideal candidate brings deep clinical knowledge, broad pharmacovigilance expertise, and strong executive presence, and will play a critical role in shaping the company's safety strategy at the highest levels, global regulatory interactions, portfolio governance, and long-term planning. Roles and Responsibilities: Enterprise Safety Leadership * Define and execute the vision, strategy, and roadmap for MSS across all therapeutic areas and lifecycle stages. * Serve as the MSS expert and advisor to R&D, Regulatory, Medical Affairs, Commercial, Legal, and senior leadership. * Chair internal safety governance forums and represent Apellis in external stakeholder meetings, regulatory interactions, and industry collaborations. Strategic Portfolio Oversight * Oversee benefit-risk strategies and signal management activities across the global portfolio, including early development, pivotal studies, post-marketing, and real-world evidence. * Ensure effective integration of safety insights into clinical development plans, regulatory submissions, labeling, and life-cycle management decisions. Regulatory Strategy and Inspection Readiness * Provide global safety input to the Head of SaBR during interactions with health authorities, including FDA, EMA, and PMDA. * Serve as a company representative in regulatory negotiations and safety-related inspections. * Ensure all MSS deliverables meet regulatory standards and support Apellis' reputation for excellence and compliance. Organizational Leadership & Development * Build, mentor, and lead a high-performing organization, including physicians, PV scientists, and cross-functional collaborators. * Drive talent development, succession planning, and organizational design to support future growth and complexity. * Champion a culture of scientific rigor, cross-functional collaboration, accountability, and innovation. Operational Excellence & Innovation * Oversee the development and execution of safety processes, standards, and technologies to improve efficiency, scalability, and scientific quality. * Advance the use of digital tools, AI, and predictive analytics in signal detection and benefit-risk management. Business Development & Growth Strategy * Provide MSS input into due diligence and risk assessment in partnership with Business Development, Corporate Strategy, and Legal. * Play a key role in integrating safety strategy into M&A, licensing, and external partnerships. Qualifications/Experience * MD/DO/Equivalent required; specialty training or board certification preferred * An MPH or equivalent training in epidemiology is preferred * 12+ years of progressive experience in drug safety and pharmacovigilance, including both clinical development and post-marketing surveillance. * 5+ years in a senior leadership or executive role within a global pharmaceutical or biotechnology environment. * Proven experience in leading high-impact global safety teams and shaping portfolio-wide safety strategies. * Demonstrated success in regulatory interactions, product labeling negotiations, and cross-functional leadership at the executive level. * Strong understanding of global PV regulations, benefit-risk assessment methodologies, and regulatory trends. * Therapeutic experience in nephrology or ophthalmology preferred. * Executive-level communication and influencing skills; proven ability to operate effectively with executive teams and external stakeholders. Travel Requirements: Up to 15% travel expected Education: MD Pay Information: Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies. The targeted base salary range for this position is $244,700-$367,000. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions. Work Arrangement: Hybrid Benefits and Perks: Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit ___ to learn more. Company Background: Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit . EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law. For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Experienced Clinical Research Associate - Full-Service - Ophthalmology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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

< Overview Alnylam is the world's leading RNA interference (RNAi) company, dedicated to transforming the lives of patients through innovative medicines. As Alnylam continues to expand its global development and regulatory footprint, Regulatory Sciences supports increasing portfolio complexity, global regulatory engagement, and heightened expectations for data quality, compliance, and operational efficiency. The Director, Regulatory Sciences Technology will play a critical role in shaping and executing the technology strategy supporting Regulatory Affairs, Safety, and Medical Writing. This role serves as the primary technology leader and business partner for Regulatory Sciences, ensuring that systems, data, and digital capabilities enable compliant, efficient, and insightdriven regulatory operations across the product lifecycle. Success in this role requires a combination of strong Regulatory Sciences business acumen and deep technical fluency across regulated platforms, data integration, and documentcentric workflows, enabling the organization to operate at global scale while meeting evolving regulatory expectations. Key Responsibilities • Serve as the primary technology leader and business partner for Regulatory Sciences, building strong relationships with leadership across Regulatory Affairs, Safety, and Medical Writing to understand objectives, priorities, and technology needs., • Develop deep expertise in Regulatory Sciences business processes, proactively identifying opportunities where technology, data, and automation can improve compliance, efficiency, and submission quality., • Lead the delivery, support, and continuous improvement of Regulatory Sciences technology platforms (e.g., regulatory information management, safety systems, document and submission platforms), providing hands-on technical leadership and architectural guidance to ensure solutions are scalable, compliant, and audit-ready., • Drive adoption of the technology operating model within Regulatory Sciences, emphasizing centralized governance, in-house leadership, and close alignment with enterprise Technology, Data, and Quality teams., • Oversee the lifecycle of Regulatory Sciences technology solutions, including requirements gathering, vendor management, implementation, and ongoing support, with a focus on architecture integrity, data consistency, and inspection readiness., • Establish and enforce technology governance, standards, and best practices, including data privacy, security, validation, and compliance with global regulatory requirements. Regulatory Data, Content & Architecture Leadership • Provide technical leadership in the design and evolution of Regulatory Sciences data and content architectures, including structured regulatory data, submission metadata, safety case data, and document management workflows., • Partner with Data and Analytics teams to enable cross-system linkage and reporting across regulatory, safety, and clinical domains, while maintaining clear data ownership and compliance boundaries., • Enable technology capabilities that support regulatory intelligence, submission planning, inspection readiness, and lifecycle management., • Translate complex technical and compliance considerations into clear guidance for Regulatory Sciences leadership and operational teams. Cross-Functional & Lifecycle Collaboration • Collaborate closely with Clinical, Medical Affairs, Quality, and Commercial Technology teams to ensure Regulatory Sciences systems integrate effectively across the product lifecycle., • Support global regulatory operations by enabling technology solutions that scale across regions, health authorities, and submission types., • Partner with Quality, Security, and Validation teams to ensure technology solutions meet internal and external compliance expectations. Vendor, Platform & Operational Leadership • Collaborate with external vendors and internal technology teams to deliver Regulatory Sciences platform integrations and enhancements., • Support and guide Application Support teams and external partners, bringing sufficient technical depth to challenge solution designs, assess architectural and data tradeoffs, and ensure vendor-delivered capabilities meet Alnylam's compliance, scalability, and integration standards., • Proactively identify functional and technical gaps in Regulatory Sciences systems and recommend improvements., • Use root cause analysis and troubleshooting skills to resolve complex functional and technical issues., • Act as an escalation point for critical technology issues impacting Regulatory Sciences operations. Qualifications • Degree in Information Technology, Computer Science, Data Science, or related field, with experience in regulated life sciences environments., • Proven business analysis skills with strong analytical and problem-solving abilities., • Effective prioritization and project management skills., • Significant experience delivering and supporting GxP-regulated technology platforms in healthcare or biopharma., • Demonstrated ability to operate at both strategic and technical depth, including evaluating architecture options, validation approaches, and data integration strategies., • Experience supporting Regulatory Affairs, Safety, Medical Writing, or adjacent development functions preferred., • Familiarity with regulatory systems (e.g., RIM, safety databases, document/submission platforms) and enterprise data ecosystems., • Strong team player with the ability to maintain effective relationships at all levels., • Ability to anticipate, understand, and address changing regulatory and business needs., • Excellent communication skills, both oral and written., • Leadership and/or supervisory experience. #LI-LN1 U.S. Pay Range $187,400.00 - $253,600.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

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.

Explore opportunities at Atrius Health, part of the Optum family of businesses. We're an innovative health care leader and multi-specialty group practice, delivering an effective, connected system of care for adult and pediatric patients at 28 practice locations in eastern Massachusetts. Our entire team of providers (physicians, AP/NPs and ancillary clinicians) works collaboratively with a value-based philosophy within our group practice as well as with hospitals, rehab and nursing facilities. Be part of our vision to transform care and improve lives by building trust, understanding and shared decision-making with every patient. Join us and discover the meaning behind Caring. Connecting. Growing together. As a Internist in this role, you'll take full responsibility for delivering comprehensive medical services to your patient panel in an ambulatory care setting. You'll work within a collaborative team that places the patient at the center, fostering continuity and trust through evidence-based care. You'll also provide leadership and mentorship to a multidisciplinary team. Primary Responsibilities: • Lead the comprehensive clinical and administrative coordination of care for a dedicated patient panel, ensuring continuity and quality across all touchpoints, • Conduct thorough health assessments, diagnose and treat acute and chronic conditions, and oversee individualized care plans in collaboration with a multidisciplinary team, • Partner with patients and families to manage care plans, demonstrating empathy and clear communication throughout the care journey, • Actively engage in population health initiatives, practice management activities, and mentorship of new clinicians, contributing to departmental effectiveness You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. Required Qualifications: • Graduate of an accredited Medical School or School of Osteopathic Medicine, • Board Certified or Bord Certified Eligible, • Unrestricted licensure in the state of Massachusetts or ability to obtain prior to start, • Active DEA License, • Master's degree in healthcare or business administration is strongly preferred (e.g., MBA, MHA, or MPH), • Board Certification in primary care specialty preferred, • Proven leadership experience is essential and some formal leadership training, • Extensive experience as a practicing physician with skills and experience acquired through 3+ years of significant managerial experience including demonstrated high level of proficiency with professional affairs, mentoring and staff development, • Experience in an ambulatory care setting and understanding of how ambulatory care functions. Compensation for this specialty generally ranges from $229,500 - $378,000. Total cash compensation includes base pay and bonus and is based on several factors including but not limited to local labor markets, education, work experience and may increase over time based on productivity and performance in the role. We comply with all minimum wage laws as applicable. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. OptumCare is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. OptumCare is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.

Job Description This is a Hybrid position with some days required to work on site. Designated School Official (DSO) • Responsibilities: • Maintain and update SEVIS records for international students, ensuring compliance with federal regulations. This includes verifying full-time enrollment, updating address and contact information, tracking CSI programs, employment status, school transfers, leaves of absence, program extensions, and program completions., • Register students' records in SEVIS at the beginning of each academic quarter, ensuring timely and accurate updates., • Review students’ files. Issue and sign Form I-20 for F-1 students and dependents, ensuring that all information is accurate, up-to-date, and compliant with federal regulations., • Provide guidance on maintaining students’ visa status and employment regulations for CPT and OPT, traveling, and re-entering the US processes., • Assist students in applying for work authorization, including issuing Curricular Practical Training (CPT) authorization in SEVIS and supporting Optional Practical Training (OPT) applications., • Advise students on a wide range of issues related to their F-1 status, such as obtaining new visas, work permits, reinstatements, changes of status, medical leaves, employment, and reduced course load authorizations. Also, provide guidance on personal, financial, enrollment, and travel matters., • Report changes to SEVIS such as student transfers, changes in the student’s program, and failure to comply with F1 requirements., • Analyze and resolve complex immigration issues to support students' statuses while studying in the United States., • Contact the SEVIS Help Desk for corrections/questions., • Function as liaison with external agencies, including the Social Security Administration, Department of Motor Vehicle, and transfer institutions., • Collaborate with internal departments, such as Admissions, Registrar, Business Office, Student Affairs, and Academics, to provide holistic support for international students., • Participate in new student orientations, and conduct immigration-related workshops for students., • Possess and maintain an understanding of changes in immigration laws and policies., • Participate in professional development opportunities. • Qualifications: • Bachelor’s degree in related field is preferred., • At least 1 year of DSO experience is preferred., • Proficiency in Microsoft Word, PowerPoint, Excel and in the use of Zoom technology is required., • Ability to communicate effectively within a diverse population of students, faculty and staff., • Successful applicants must possess organizational skills and have the ability multi task and prioritize tasks assigned. • Benefits Offered: • Health Insurance., • Dental Insurance, • Vision Insurance, • 401K, • Life Insurance, • Paid Time Off (Vacation & Earned Sick Time), • Employee Discount ProgramCompany DescriptionOur school is focused on helping students get the skills and support they need to reach their goals. Whether you are looking to improve your professional skills or to pursue further academic study, CSI can help!Our school is focused on helping students get the skills and support they need to reach their goals. Whether you are looking to improve your professional skills or to pursue further academic study, CSI can help!

Description: JOB SUMMARY: Novocure provides cancer patients with a novel treatment for aggressive cancers using Tumor Treating Fields (TTFields). The Senior Manager, Product Management will lead cross-functional strategy and readiness for consumable equipment and accessories (both sterile and non-sterile) that are integral to Novocure's medical device systems. The ideal candidate will have direct experience with Class II and/or Class III medical devices and their consumables, operating within highly regulated development environments under FDA and EU MDR frameworks. This includes responsibility from concept through end-of-life for consumables supporting device performance, patient usability, and regulatory compliance. This is a full-time, exempt position located in our Portsmouth, NH office. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Act as the product owner for all consumables and accessories (e.g., transducer arrays, bags, and related components) associated with the Optune device, • Partner with R&D and Quality to define user needs, design inputs, and risk mitigation for consumables and accessories, ensuring compliance with relevant standards and regulations (ISO 13485, ISO 14971), • Collaborate with cross-functional teams to provide engineering and other teams with guidance on new product requirements and improvements, • Support development, validation, and manufacturing transfer of consumables (sterile and non-sterile) for Class II/III medical devices, • Ensure that Novocure products meet patient and market needs through coordinated launches and lifecycle management activities, • Generate and coordinate target product profiles upfront in the product cycle, defining value propositions and clinical/commercial benefits, • Collaborate with Regulatory Affairs to ensure appropriate classification, labeling, and submission documentation for consumable products, • Develop and maintain methods for capturing and analyzing patient feedback, product costs/tradeoffs, and market opportunities to guide roadmap decisions, • Lead efforts to incorporate metrics into launches focused on improving user experience, safety, and performance at scale, • Strongly collaborate with project managers, development teams, and commercial teams throughout the development cycle to lead all aspects of productization, • Act as the connecting link between Product Development and Commercial/Medical teams to ensure alignment from design to market deployment QUALIFICATIONS/KNOWLEDGE: • Degree in engineering, biomedical engineering, or related field; MBA preferred, • Minimum 8 years of experience in product management or development within the medical device industry, with demonstrated involvement in consumable or disposable product lines (sterile and/or non-sterile), • Experience with wearable medical devices strongly preferred, • Hands-on experience with Class II or Class III medical devices in a regulated environment (FDA QSR, EU MDR), • Knowledge of design control (21 CFR 820.30), risk management (ISO 14971), sterility validation, and ISO 13485 quality systems, • Proven ability to collaborate with cross-functional and global teams including R&D, Quality, Regulatory, Manufacturing, and Supply Chain, • Prior experience leading or supporting 510(k), PMA, or CE-Mark submissions involving consumable components is highly beneficial, • Strong product knowledge combined with good acumen related to clinical and commercial value propositions, • Experience with globally dispersed teams and managing external development or manufacturing partners OTHER: • Following Novocure's values and code of conduct, • Following Novocure's values and code of conduct, • Acting always in line with Novocure's confidentiality policies and procedures, • Completion of assigned trainings in due time, • Assure compliance with applicable standards, regulations, laws, and guidelines relevant to the position, • Conduct additional tasks in the course of ongoing improvement initiatives or projects as advised by management, • Ability to lift up to 20 pounds, • Up to 30% (domestic and international) travel may be required. Novocure is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veteran and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Novocure is committed to providing an interview process that is inclusive of our applicant's needs. If you are an individual with a disability and would like to request an accommodation, please email ___ ABOUT NOVOCURE: Our vision Patient-forward: aspiring to make a difference in cancer. Our patient-forward mission Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy. Our patient-forward values • innovation, • focus, • drive, • courage, • trust, • empathy #LI-RJ1

Marketing Cambridge, MA * ID: 26R-18 * Full-Time/Regular This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a flexible, "magnet not mandate" approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs. Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary: Position Summary Akebia is seeking an experienced, mission-oriented and collaborate Director, Marketing to play a pivotal role in driving adoption and sustained growth of Vafseo. This position will be responsible for developing and executing the US brand strategy for HCPs, patients and payer/population health decision makers for Vafseo (vadadustat). This individual is accountable for translating brand strategy into highly impactful execution across HCP and consumer channels including personal promotion, non-personal promotion and peer-to-peer engagement. The role requires a strategic thinker who is also highly execution-oriented and can operate in a fast-moving organization where adaptability, strong communication, and cross-functional leadership are critical to success. This individual will partner closely with Sales, Market Access, Commercial Operations, Medical, Legal and Regulatory teams to ensure strategic execution and performance. This role reports to the Vice President, Marketing and will manage a team of three individuals. Summary of Key Responsibilities • Lead development of overall Vafseo brand strategy and message, • Manage day-to-day brand operations, ensuring timely execution of campaigns and materials across integrated promotional programs (personal promotion, non-personal promotion, peer-to-peer programs and Key Medical Expert engagement), • Partner with Commercial Analytics to generate customer and performance insights and lead the translation of those insights and field feedback into clear strategic priorities and actionable marketing programs, • Partner with key stakeholders across Medical Affairs, Market Access, Sales, Regulatory, Legal and Compliance to deliver high-quality, compliant promotional and educational content, • Effectively lead agencies to achieve high quality deliverables within time and budget scopes, • Champion strategic project initiatives to drive future brand growth and operational efficiencies, including AI-enabled solutions, • Define KPIs to measure marketing performance, ROI, brand impact and contribution to prescription growth; regularly report outcomes and optimization recommendations to leadership., • Manage budget to corporate targets, • Contribute to a collaborative, mission-driven culture focused on delivering meaningful outcomes for patients, • Bachelor's Degree required, MBA is a plus, • Minimum of 10 years in the pharmaceutical or biotech industry and 8+ years of proven experience in brand marketing, • Experience in nephrology is a plus, • Experience in developing and executing personal, non-personal and peer-to-peer marketing, • Proven ability to influence without authority and partner with cross-functional teams in the development and delivery of brand strategic imperatives, • Proven project and vendor management skills including budget management, planning, prioritization, objective setting, and logistics execution, • Strong written and presentation skills Targeted Base: *$213,977-$264,325 *Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: ___ Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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 Director, Pharmaceutics will be responsible for leading Drug Product (DP) activities across a portfolio of programs at Ardelyx. Reporting to the Senior Director, Pharmaceutics, this role will partner closely with CMC, Supply Chain, Quality Assurance, Regulatory Affairs and various functions to direct activities associated with product development and/or manufacturing in alignment with business objectives.Responsibilities: • Manage all Drug Product (DP) efforts, including formulation development (adult and pediatric), process development, tech transfer, and the manufacture of DP for clinical and commercial purposes, • Manage phase-appropriate DP project plans; develop outsourcing strategies, prepare RFPs, and manage the successful execution of plans consistent with corporate objectives and compliant with cGMP requirements, • Provide assistance on the preparation of the DP section of various regulatory documents (IND, NDA, etc.), • Represent the DP function, and when needed the broader Tech Ops function, on various cross-functional teams including internal project teams as well as external steering and operating teams with contract manufacturing and/or corporate partners, • Integrate DP activities with those of sister CMC functions, Supply Chain, Quality Assurance, and Regulatory Affairs, • Work with Supply Chain to ensure a continuous and uninterrupted supply of CTM to clinical sites and commercial materials to marketPlease note: this position is a hybrid based out of our Waltham, MA office and requires presence on-site 2-3 days per week.Qualifications:, • B.S. degree in Pharmaceutics, Pharmaceutical Sciences or Chemical Engineering with 10+ years of industry experience or equivalent experience, • Experience in the areas of formulation development, DP process development, tech transfer, and manufacturing, • Experience working in close collaboration with technical, regulatory, quality, project management, legal, finance, and supply chain functions, in a cGMP operational environment, • Experience in managing outsourced development, tech transfer, and manufacturing efforts as well as associated operating budgets, • Experience in preparing and defending regulatory documents including briefing books for regulatory meetings, INDs, and NDAs, • Desire to work "hands on", setting priorities, meeting timelines, motivating others, and managing departmental budgets, • Excellent communication skills and the ability to shape, frame, and present to diverse internal and external audiences are requisite, • Periodic travel to manufacturing and other partner sites is required (approximately 10 - 20% of time)The 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.

Who is BlueRock? BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson's disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives. The Head of Medical Writing will provide strategic and operational leadership for all Medical Writing activities to support BlueRock's portfolio, from early development through product registration. This role is accountable for establishing and overseeing a cohesive, scalable Medical Writing function that delivers high-quality regulatory documents that are aligned with BlueRock's global strategy, development timelines, and corporate priorities. The Head of Medical Writing will develop and lead an internal medical writing team, oversee vendor partnerships, and serve as a key strategic partner to Regulatory Affairs, Pharmacovigilance, Clinical Development, Clinical Operations, Biometrics, Translational Science, and Technical Operations. This role will also help shape future-state capabilities, including AI-enabled medical writing, platform-based content reuse, and collaboration models with Bayer colleagues. • Define and own a Medical Writing strategy and roadmap that is aligned with BlueRock's pipeline, regulatory milestones, and long-term growth., • Establish standards, processes, and governance to ensure consistency, quality, and inspection readiness across all Medical Writing deliverables., • Partner with Regulatory Affairs leadership to ensure that Medical Writing is fully integrated into regulatory strategy, Regulatory Agency engagement, and submission planning., • Drive a platform-based approach to document development, enabling efficiencies and reuse of content across programs where appropriate., • Represent Medical Writing in cross-company forums as needed., • Provide oversight and accountability for all Medical Writing deliverables across BlueRock's portfolio, including clinical study protocols, IBs, INDs/CTAs, briefing books, Agency responses, DSURs/annual reports, CSRs, integrated summaries, and BLA/MAA modules., • Ensure delivery of documents that are on time, of high quality, and aligned with evolving global regulatory expectations., • Identify opportunities to improve speed, quality, and scalability of document development., • Lead resource planning (internal FTEs and external medical writing vendors) to support current and future program needs., • Oversee and manage vendors and consultants to ensure consistent value, quality, and alignment., • Serve as escalation point for complex document development challenges., • Build, lead, and develop a high-performing internal Medical Writing team, including Associate Directors and/or Principal Medical Writers., • Provide coaching, mentoring, and performance management to support professional growth and retention., • Foster a culture of accountability, collaboration, and continuous improvement, • Lead initiatives to modernize Medical Writing activities, including evaluation and pilot implementation of:, • AI-enabled authoring, QC reviews, and content reuse tools, • Digital workflows and submission efficiencies, • Define and manage collaboration models with Bayer, including potential shared services and/or AI-enabled pilots., • PhD, PharmD, MD, or other advanced degree in a scientific/medical discipline preferred; Bachelor's degree required., • 10+ years of medical writing experience within the biopharma industry; experience with cell and/or gene therapies strongly preferred., • Demonstrated leadership of global regulatory writing programs, including INDs/CTAs and marketing applications (BLAs/MAAs)., • Deep understanding of drug and biologics development, CTD structure, ICH and GxP guidelines, regulatory interactions, and submission processes., • Proven leadership, including building and managing teams., • Strong strategic thinking combined with hands-on execution capability., • Excellent written and verbal communication skills., • Experience working cross-functionally in fast-paced, matrixed organizations., • Familiarity with document management systems and authoring tools (eg, Veeva, SharePoint, StartingPoint)., • Ability to travel within US/Canada (and limited EU travel, potentially) up to 20%.

Explore opportunities at Atrius Health, part of the Optum family of businesses. We're an innovative health care leader and multi-specialty group practice, delivering an effective, connected system of care for adult and pediatric patients at 28 practice locations in eastern Massachusetts. Our entire team of providers (physicians, AP/NPs and ancillary clinicians) works collaboratively with a value-based philosophy within our group practice as well as with hospitals, rehab and nursing facilities. Be part of our vision to transform care and improve lives by building trust, understanding and shared decision-making with every patient. Join us and discover the meaning behind Caring. Connecting. Growing together. As a Internist in this role, you'll take full responsibility for delivering comprehensive medical services to your patient panel in an ambulatory care setting. You'll work within a collaborative team that places the patient at the center, fostering continuity and trust through evidence-based care. You'll also provide leadership and mentorship to a multidisciplinary team. Primary Responsibilities: • Lead the comprehensive clinical and administrative coordination of care for a dedicated patient panel, ensuring continuity and quality across all touchpoints, • Conduct thorough health assessments, diagnose and treat acute and chronic conditions, and oversee individualized care plans in collaboration with a multidisciplinary team, • Partner with patients and families to manage care plans, demonstrating empathy and clear communication throughout the care journey, • Actively engage in population health initiatives, practice management activities, and mentorship of new clinicians, contributing to departmental effectiveness You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. Required Qualifications: • Graduate of an accredited Medical School or School of Osteopathic Medicine, • Board Certified or Bord Certified Eligible, • Unrestricted licensure in the state of Massachusetts or ability to obtain prior to start, • Active DEA License, • Master's degree in healthcare or business administration is strongly preferred (e.g., MBA, MHA, or MPH), • Board Certification in primary care specialty preferred, • Proven leadership experience is essential and some formal leadership training, • Extensive experience as a practicing physician with skills and experience acquired through 3+ years of significant managerial experience including demonstrated high level of proficiency with professional affairs, mentoring and staff development, • Experience in an ambulatory care setting and understanding of how ambulatory care functions. Compensation for this specialty generally ranges from $229,500 - $378,000. Total cash compensation includes base pay and bonus and is based on several factors including but not limited to local labor markets, education, work experience and may increase over time based on productivity and performance in the role. We comply with all minimum wage laws as applicable. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. OptumCare is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. OptumCare is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.

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 Vice President , Global Clinical Lead - 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: Responsible for leading as the Global Clinical Lead a large solid tumor oncology franchise that encompass multiple late stage and early phase programs . Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate governance committees. Oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP). Responsible for review of synopses, other relevant clinical study documents and critical Study Results. Provide leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads. Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area. ACCOUNTABILITIES: - Clinical Development team participation and leadership - Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies. - Consistent with the Takeda R&D Oncology Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regions - Part of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group - Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the 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: 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. - Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed. - Providing strategic input into global development strategies and plans for all compounds in OTAU. - Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities) - Primary interface with Medical Affairs team for strategy and to support of product commercial efforts - Contributing to the creation and maintenance of regional KOL network - Providing recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts - Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation - Synopsis / Protocol Development, Study Execution, & Study Interpretation - Consistent with membership of the Clinical Review Board Committee, responsible for critical review of synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds. - Trial Medical Monitoring - Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. - External Interactions - Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. - Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment. - Proactive identification of challenges and development of contingency plans as appropriate. - Due Diligence, Business Development and Alliance Projects - Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment. - Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities. - 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. - Assigns and manages clinical science staff who are involved in many of these activities. - Leadership, Task Force Participation, Upper Management Accountability - Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area. Leads TGRD internal teams and global cross-functional teams. Works with functional leadership to prioritize projects within the therapeutic area. - 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: Experience - MD or combined MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including minimum 10 years late phase clinical development experience with a focus on medical oncology - Clinical Training and Clinical Experience in Hematology/Oncology and/or Medical Oncology especially in solid tumor malignancies - Strong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapies. - Experience in conducting and/ or leading multiple clinical trials involving immune based therapies - Proven experience in successfully leading and supervising direct reports including several physicians, physician scientists, scientists within a clinical development team in a global matrix environment. - Demonstrated ability to foster a high-performance culture and build organizational capabilities. - Strong leadership commitment to diversity, equity and inclusion, with experience in creating an inclusive and collaborative team environment that leverages diverse perspectives. - Previous experience in successfully leading several clinical development team/matrix team with responsibility for Global studies in multiple regions. Clinical Development experience beyond US/EU - Solid and Multiple experience in preparing and interacting with multiple regulatory agencies including FDA, EMA, and others - Multiple NDA/MAA submission experience - Proven ability to lead and manage highly trained medical, scientific, and technical professionals. - Superior communication, strategic, interpersonal and negotiating skills - Enterprise level leadership with the ability to inspire, motivate and drive results - Excellent communication both verbally and in writing 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 across multinational business cultures TRAVEL REQUIREMENTS: - Willingness to travel to various meetings or client sites, including overnight trips. Several international travels may be required. - Requires approximately 25-35 % 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 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 This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. #LI-JT1 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: $307,300.00 - $482,900.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

< Overview We are looking for a Thought Leader Liaison to support the promotion of AMVUTTRA (vutrisiran). The Thought Leader Liaison (TLL) is a commercial, field-based, customer facing role primarily focused on the identification and development of enduring relationships with both current and emerging key opinion leaders (KOLs). S/he will focus on engaging KOLs to solicit insights and develop advocacy aligned to commercial and marketing strategy and messaging. As integral strategic partners to Alnylam's internal and field-based teams, TLLs support cross functional, commercial opportunities and engagements with KOLs including marketing education initiatives, advisory boards, speakers bureau strategy, congress strategy, and consulting opportunities. Additionally, the TLL helps to inform commercial and marketing strategy, messaging, and resources through the sharing of insights and connecting KOLs with Alnylam cross functional partners. The TLL role will work closely and collaboratively with internal partners including marketing, medical affairs, sales, legal, and compliance to maintain KOL coordination but also to manage appropriate distinction of roles and boundaries among the expertise areas. Our team is at the forefront of commercializing an industry-leading TTR franchise, focused on advancing AMVUTTRA (vutrisiran) across ATTR cardiomyopathy (ATTR-CM) and hereditary ATTR polyneuropathy (hATTR-PN). Following a successful launch in ATTR-CM, AMVUTTRA is positioned to play a leading role in a rapidly growing market with ongoing unmet need for patients living with transthyretin amyloidosis. Key Responsibilities • Creates and executes objective-based, KOL engagement plans to include the identification and curation of relationships with current and emerging KOLs in the academic and community setting to support insight generation and development of advocacy in a dynamic market., • Assist Sr. Director, TLL Lead, with ongoing evaluation and creation of TLL strategy including focus, priorities, and tactical execution., • Solicits pre-determined disease and brand insights through field-based, 1v1 KOL interactions and utilizes these insights to identify market gaps and/or market opportunities to support the development of commercial and marketing strategy, initiatives, and resources., • Proactive collaboration with cross-functional field colleagues to ensure a One Alnylam approach to customer engagement., • Partners with cross functional colleagues to engage with professional societies., • Engages in field-based, 1v1 interactions with KOLs using approved TLL resources to generate insights and align KOL beliefs to ATTR-CM and hATTR-PN amyloidosis and AMVUTTRA (vutrisiran) disease and brand messaging to support advocacy development., • Identify KOLs for approved Alnylam consulting engagements including the speaker's bureau, congress and regional symposiums, advisory boards, review of marketing materials, and KOL videos, etc., • Support the execution of US marketing advisory boards including insights for creation of content and selection of advisors., • Serve as a participant in cross functional, commercial planning and execution through leadership and support of quarterly business and account reviews., • Be an active contributor of TLL strategy, process, and congress identification by assisting the Sr Director team lead in the following: development of processes and tools to capture, assess, and communicate performance of TLL KOL engagement strategy., • Develop strategies for the acquisition of relevant market insights, interpretation of insights, and approved sharing of insights with internal stakeholders., • Support identification of opportunities for participation at congresses and regional conferences and develop and execute on the TLL strategy for these meetings., • Collaborate with legal, regulatory, and compliance stakeholders to ensure compliant development and execution of TLL strategy and tactics., • Owns, develops, and executes on KOL engagement strategies for Alnylam's participation at key, national congresses within the amyloidosis community., • Develops opportunities to communicate execution and commercial impact of the TLL role with internal partners and maintains proactive communication plans with cross functional partners to coordinate activity and ensure role clarity., • Operates to the highest standard in alignment with Alnylam's code of ethics and compliance SOPs, ensuring all interactions with KOLs are on-label and consistent with commercial, regulatory, and legal guidelines. Qualifications • BS/BA degree (science degree preferred), • 8+ years of experience in one or more of the following: Field Sales, Product Marketing, and / or Medical Affairs within the pharmaceutical or biotech industry., • Experience and proven success in working with and interacting with HCPs (Healthcare Providers), KOLs (Key Opinion Leaders), and COEs (Centers of Excellence), • A track record of executing strategic and tactical plans that have delivered strong commercial results., • Candidates with demonstrated TLL experience or marketing experience are highly encouraged to apply., • Deep experience in Neurology and Cardiology is preferred. Experience in high science areas and diseases is desirable., • Proven ability to influence without authority and work with cross-functional teams in the development and delivery of brand strategic imperatives., • Thrives in a highly entrepreneurial biotech environment and embraces Alnylam's culture of science, passion, and urgency., • Maintains a growth mindset and uses curiosity to uncover opportunities for continuous development and improvement., • Excellent interpersonal and communication skills., • Valid driver's license., • Ability to travel 60-70% as necessary. Act compliantly and with highest integrity. Clear Alignment with Alnylam Core Values: • Commitment to People, • Innovation and Discovery, • Sense of Urgency, • Open Culture $191,300.00 - $258,700.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

< Overview: We seek aPatient Education Liaison (PEL)to supportAMVUTTRA (vutrisiran). The U.S. Food and Drug Administration (FDA) recently approved the supplemental New Drug Application (sNDA) for AMVUTTRA (vutrisiran).The approval expands theindicationfor AMVUTTRA, which now becomes the first and only therapeutic approved by the FDA for the treatment of ATTR-CM and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.The PELis a criticalcomponentof the product brand commercial strategy and works in close coordination with Field Sales, Field Reimbursement, Patient Services, Advocacy, and Marketing teams to support Alnylam's patient-focused vision of harnessing a revolution in biology for human health. The Patient Education Liaison is responsible for educating patients, caregivers, families, nurses, medical assistants, office staff, professional nursing organizations, and pertinent community groups on disease state and Alnylam's RNAi treatments for all Alnylam brands. Using approved materials, the Patient Education Liaison will educate on the disease state, Alnylam treatments, and Alnylam's services, through phone-based, in-person, and virtual meetings. Central to this role is the ability to work with regional, field-based and internal colleagues to identify barriers to patient access and work to resolve them. The successful candidate must be passionate about science and deeply motivated by the quest of delivering education to patients and their families with the long-term success of the company in mind. The ideal candidate will be a self-motivated, self-starter with an innovative, entrepreneurial spirit. Key Responsibilities: * Actively collaborates with Field Sales, Patient Services, Medical Affairs, Marketing,Advocacyand other critical internal teams to increase disease-state awareness and early diagnosis * Leads regional effort to provide disease-state education, treatmenteducationand support to patients their families/caregivers, nurses, medical assistants, office staff, nursing organizations, and community groups * Maintains disease-state and productexpertisethrough continuing medical education and attendance at relevant symposia,conferencesand other educational opportunities * Provides comprehensive updates on activity toPELLeadandregional colleagues, ensuring that the regional team appropriately works as one entity to support patients in early diagnosis and access to treatment * Accountable for executing on targeted workplan * Completes required work in CRM system tofacilitatetracking of critical launch metrics * Ensures compliance with all corporate and industry policies with training provided by Alnylam Commercial, Legal, Regulatory and Compliance Officers Qualifications: * Bachelor of Science in Nursing, Registered Nurse(required) * 2+yrs. Pharmaceutical/biotech experience in a similar role * Experience supporting and providing education to patients, family members, nurses, medical assistants, office staff, nursing organizations, and community groups * Strong presentation skills * Cardiology experience preferred * Exceptional interpersonal skills, professional communications, problem-solving,compassionand the ability to navigate difficult conversations * Ability to translate scientific/medical information into patient-friendly language * Ability to work well and lead within cross-functional groups and in a matrix organization * Desire to innovate and work in a fast-paced, energetic environment * Self-starter who is highly passionate about Alnylam's core values:Commitment to People, Fiercely Innovative, Open Culture, Passion for Excellence, and Purposeful Urgency. * This position requires frequent travel within the region and at times nationally. Includesovernight travel and weekends. * Must be able to travel up to 75% * Valid Driver's License #LI-ST1 #LI-Remote U.S. Pay Range $136,000.00 - $184,000.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

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

< Overview The Global TTR Marketing Associate Director will play a crucial role in shaping launch strategy and driving pre-launch market readiness for nucresiran, Alnylam's third-generation RNAi therapeutic under investigation for the treatment of ATTR amyloidosis. In this role, the Associate Director will lead global market development efforts for hATTR-PN, incorporating regional and local insights to inform positioning, messaging, and launch readiness across markets. The role will work closely with cross-functional team members, including Medical, Access, Regulatory, and regional Commercial teams, to ensure coordinated planning and execution. In addition, the Associate Director will partner closely with the AMVUTTRA Global Brand Team to align nucresiran launch planning with overall TTR franchise strategy and portfolio priorities, ensuring a cohesive and forward-looking approach across the lifecycle. This role reports to Senior Director, Nucresiran Global Brand Lead and is a hybrid role based in Cambridge, MA, with 2-3 days/week onsite. Key Responsibilities • Lead global market development strategy for hATTR-PN to prepare the market for nucresiran entry, including campaign concepting, market research, and development of global assets, • Develop a compelling and differentiated global narrative and messaging that reflects customer needs and beliefs and remains resilient to evolving market conditions, • Translate global strategy into clear and actionable messaging frameworks and toolkits that enable consistent and effective local market activation, • Collaborate closely with the AMVUTTRA Global Brand Team to align nucresiran strategy with overall TTR franchise priorities and incorporate portfolio learnings into launch planning, • Partner with Medical Affairs, Market Access, Competitive Intelligence, Clinical Research, Clinical Operations, Regulatory, Legal, and regional marketing teams as an active member of the Nucresiran Global Brand Team to ensure aligned and compliant pre-launch planning, • Shape key opinion leader engagement and congress strategy with a focus on neurology and hATTR-PN to support executive engagements and disease education, • Work with cross-functional partners to integrate commercial and customer insights into the Integrated Evidence Plan early and proactively, • Contribute to cross-functional diagnostic innovation workstreams to support earlier and more accurate patient identification, • Collaborate with market research and analytics teams to monitor market dynamics and generate actionable insights, and provide strategic guidance at both global and regional levels as needed to maximize launch readiness and impact Qualifications • BS or BA degree, preferably in science or business, with a minimum of seven years of experience in the pharmaceutical or biotechnology industry, • At least five years of experience in marketing and/or brand launch planning, including experience with in-line brand management in competitive therapeutic areas, • Global product launch experience within an established therapeutic-area franchise, including portfolio positioning and lifecycle coordination, strongly preferred, • Experience working across global and regional teams to align strategy and execution within a matrixed organization, • Ability to adapt quickly to changes in clinical data, competitive dynamics, and market conditions, • Strong collaboration skills and comfort operating in fast-paced, high-pressure environments, • Strong project and program management skills, with the ability to lead initiatives from planning through execution, • Excellent written and verbal communication skills, • Experience managing external agencies and vendors #LI-ST1 U.S. Pay Range $168,800.00 - $228,500.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Experienced Clinical Research Associate - Full-Service Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

< Overview: The Director, Process Sciences will be responsible for downstream process development, optimization, and process characterization of antibody oligonucleotide conjugates for platform delivery of oligonucleotide APIs. The candidate will work closely with cross-functional teams and contract manufacturing organizations (CDMOs) on process development, process transfer, and oversight of manufacturing processes. This position is onsite and will be located at our Kendall Square offices in Cambridge, MA. Responsibilities: • Oversee downstream process development and contract manufacturing of antibody and antibody-oligonucleotide conjugates., • Contribute to the development of long-term strategy for platform delivery programs and provide recommendations to the leadership team., • Author and review technical documentation supporting API manufacture and process characterization activities., • Accountable for the preparation of the Quality section for regulatory filings and interaction with regulatory authorities., • Contribute to strategic technical discussions and present progress at internal and external meetings., • Represent Process Development on cross-functional teams including internal cross-functional program teams and externally with contract manufacturing and/or corporate partners., • Effectively integrate Process Development activities with other CMC functions in Drug Substance Development & Manufacturing, Analytical Development, Quality Assurance, and Regulatory Affairs., • Periodic travel to manufacturing and other partner sites is required. Qualifications: • Ph.D. in chemistry, chemical engineering, or biochemical engineering with at least 10 years of process research and development experience in the manufacture of antibody and antibody-drug conjugates., • Extensive experience in downstream process development including purification and characterization of ADCs including mAbs., • Experience in process transfer and management of contract manufacturing at CDMOs., • Hands-on experience with analytical methods for process and product characterization as well as conjugation is a strong plus., • Excellent organizational and communication skills., • Demonstrated strong operational execution and problem-solving skills., • Desire to work in a fast-paced, deadline-driven environment. U.S. Pay Range $197,100.00 - $266,700.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

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: Medical Director, Pharmacovigilance (PV) leads product safety strategy, overseeing risk management, signal detection, and regulatory compliance from clinical development through post-market, serving as the medical safety expert, managing PV operations, guiding safety document authoring, and collaborating cross-functionally to ensure safe and effective product use. Responsibilities: • Serve as Global Safety Lead (GSL) and the safety expert for assigned pharmaceutical products, accountable for the safety strategy and major safety deliverables for each assigned product, • Lead the Safety Management Team (SMT) for assigned compounds and products and represents the cross functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders, • Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature for assessment of benefit-risk profile and updating of the benefit-risk documents, e.g., RMPs, for assigned compounds and products, • Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products, • Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees, • Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, and CTAs) in collaboration with cross-functional colleagues, • Provide patient safety input to the clinical development program for assigned products and development compounds, and represent PV on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents as applicable, • Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Biometrics, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal, • Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents, • Up to 10% of domestic travel to attend meetings Qualifications:, • Doctor of Medicine (M.D.) with 8+ years of pharmacovigilance, drug safety, or related experience or equivalent experience, • Extensive experience in evaluating signal detection activities and analyzing safety data, identify trends, and detect new or emerging safety signals, • Ability to analyze using statistical methodologies (e.g., disproportionality analysis) to assess potential safety concerns and evaluate the frequency and severity of adverse events, • Proven strategic mindset to analyze information to strategize, recommend, and develop risk management plans, • Advanced analytical skills to evaluate and develop periodic safety reports, including Periodic Benefit Risk Evaluation Reports (PBRER), Developmental Safety Update Reports (DSURs), and Periodic Adverse Drug Experience Reports, • Proven ability to utilize MedDRA and assign appropriate MedDRA terms to describe adverse events and WHO DD dictionary coding to accurately capture and standardize information related to medicinal products

Marketing Cambridge, MA * ID: 26R-16 * Full-Time/Regular This position is currently based in our Cambridge, MA office. Please note that our offices will be relocating to Waltham, MA later this year, and this role will transition accordingly. We follow a flexible, "magnet not mandate" approach to in-office work, encouraging collaboration and onsite engagement while supporting hybrid flexibility based on role and business needs. Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Associate Director, Marketing Job Summary: Akebia is seeking an experienced, mission-oriented and collaborative Associate Director to play a pivotal role in driving adoption and sustained growth of Vafseo. This position will focus on executing brand strategies, optimizing business performance and deepening engagement with key nephrology stakeholders. The ideal candidate is a hands-on, data-driven marketer who excels at translating insights into compelling value stories, brings a mix of strategic thinking and tactical agility and has experience or interest in AI technologies. Akebia has a strong cross-functional team, and this position will serve as an integral member to advance the strategic and tactical plans for Vafseo. The Associate Director will partner closely with Field Sales, Sales Training, Commercial Analytics, Legal, Regulatory and Medical Affairs colleagues in order to successfully develop and execute marketing programs and initiatives. This role reports directly to the Director, Marketing. Specific Job Responsibilities • Lead personal promotion and peer-to-peer strategy and execution for Vafseo including creation of all assets and content for HCPs and patients, • Ensure alignment across brand messaging, promotional materials and customer engagement initiatives, • Lead advisory boards to strengthen scientific and brand credibility, • Partner with speaker program operations to optimize engagement and pull through of promotional speaker programs, • Partner with medical and meetings management to develop conference strategy and lead congress promotion efforts to maximize brand presence, • Partner closely with field sales, market access and sales training to ensure effective implementation of brand messaging and key marketing initiatives, • Effectively manage agencies to achieve high quality deliverables within time and budget scopes, • Collaborate effectively with Promotional Review Committee (PRC) partners to ensure execution aligns with brand strategy and marketing timelines., • Support additional marketing initiatives and special projects as needed, including brand planning, budget tracking, and other ad hoc assignments to advance business objectives, • Measure and optimize personal promotion and peer-to-peer tactic effectiveness, • Support strategic project initiatives to drive future brand growth and operational efficiencies, including AI-enabled solutions, • Manage budget to corporate targets, • Contribute to a collaborative, mission-driven culture focused on delivering meaningful outcomes for patients Basic Qualifications • Bachelor's Degree required, MBA is a plus, • 7+ years of proven experience in brand marketing with a minimum of 3 years of HCP or patient product management experience Preferred Qualifications • Experience in nephrology is a plus, • Proven project and vendor management skills, • Proven ability to influence without authority and partner with cross-functional teams, • Proven project and vendor management skills including budget management, planning, prioritization, objective setting, and logistics execution, • Strong written and presentation skills, • Up to 15% travel to attend sales meetings, customer visits, and relevant medical meetings/congresses within the U.S. Compensation: Targeted Base: $177,175 -$218,863* *Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: ___ Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

< Overview The Scientific Director, Global Medical Affairs - ATTR serves as a global scientific subject matter expert supporting the ATTR franchise, with a primary focus on scientific content generation and written scientific outputs. This role reports to the VP, Medical Affairs, TTR and works in close partnership with Global Medical Leads across ATTR assets (e.g., Vutrisiran, Nucresiran). The role will contribute deep scientific expertise to publications strategy, investigatorinitiated studies (IIS), research collaborations, posthoc analyses, Phase 4 activities, and business development due diligence, with a strong emphasis on handson writing, protocol development, and scientific review. The role supports increasing demand for highquality scientific content and evidence generation across the ATTR franchise and will function as a core internal SME supporting crossfunctional teams. Key Responsibilities Scientific Content Development & Publications • Serve as a scientific SME contributing to global publication strategy, planning, and execution., • Draft, review, and critically edit scientific manuscripts, abstracts, posters, slide decks, and congress materials., • Provide scientific leadership on data interpretation and scientific storytelling, ensuring accuracy, clarity, and alignment with the overall evidence strategy. Evidence Generation • Support development, review, and execution of the integrated evidence generation plan across the ATTR franchise., • Support IIS, Research Collaboration, Phase 4, post-marketing, post-hoc analyses, real-world evidence activities, including scientific review, study and analyses design, feasibility assessment, data interpretation, and ongoing oversight., • Lead protocol development and review across evidence generation activities, with a focus on scientific rigor and relevance. CrossFunctional Scientific Partnership • Collaborate closely with Global Medical Leads, Publications and Scientific Communications, Clinical Research, Regulatory, HEOR, and Commercial partners to ensure alignment and scientific integrity., • Support crossfunctional deep dives led by Value Evidence Strategy teams, synthesizing scientific and clinical data into clear, written outputs., • Provide scientific input into business development and licensing (BD&L) due diligence, including literature reviews, data gap assessments, and scientific risk evaluation., • Contribute to internal briefing documents, scientific summaries, and strategic analyses to inform senior leadership decisionmaking., • Serve as a trusted internal scientific reviewer for medical materials, protocols, and externalfacing scientific content., • Ensure all activities adhere to medical governance, compliance, and ethical standards. Qualifications • PharmD, PhD or MD, • 3-5+ years of relevant experience within the pharmaceutical or biotechnology industry., • Experience in cardiovascular, renal, metabolic, or ATTR disease areas strongly preferred., • Demonstrated primary authorship and substantial contribution to peerreviewed publications., • Strong experience in medical, scientific, and grant writing (e.g., research proposals, manuscripts) and reviewing or developing clinical or postmarketing study protocols., • Prior exposure to BD due diligence or structured scientific evaluations strongly preferred., • Deep interest in and aptitude for written scientific work; this role emphasizes writing over presenting., • Ability to critically analyze data and translate complex science into clear written narratives. U.S. Pay Range $238,800.00 - $323,000.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ___ AboutAlnylam We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client., • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings., • Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget., • Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed., • Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format., • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs., • Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables., • Performs online clinical literature searches and complies with copyright requirements., • Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities., • Mentors and leads less experienced medical writers on complex projects, as necessary., • Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing., • Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership., • Completes required administrative tasks within the specified timeframes., • Performs other work-related duties as assigned., • Minimal travel may be required (less than 25%). At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $80,600.00 - $145,000.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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