Vice President, Head of Medical Affairs, Neuroscience Ipsen SAVice President, Head of Medical Affairs, NeuroscienceCambridge, MA$382,000–$425,000 / yearJob Description: The Vice President, Head of Medical Affairs, Neuroscience, will be a strategic partner for the assets under his/her responsibility, and will lead a dynamic US-based group overseeing the medical strategy and operational execution of all the multiple functions and therapeutic indications for all marketed products, products in development and provide expertise in business development, as required. Proven leadership in Medical Affairs, including experience developing medical plan strategies, managing cross-functional teams across global Medical, R&D, Commercial, and Regulatory functions, and providing effective oversight of Medical Affairs teams representing multiple functional areas.
Senior Director, Bioanalytical and Biomarker Development Editas Medicine IncSenior Director, Bioanalytical and Biomarker DevelopmentCambridge, MAThis highly visible role will be accountable for the preclinical bioanalytical strategy, biomarker strategy, data quality, and regulatory readiness, ensuring successful EDIT-401 IND submission and Clinical Trial execution. Characterizing Your Impact: As the Senior Director, Bioanalytical and Biomarker Development, you will: Lead assay development, qualification, validation, and execution for measuring drug product components, immunogenicity, biomarkers, and other analytes in biological matrices.
Senior Manager, Data Management Xenon PharmaceuticalsSenior Manager, Data ManagementNeedham, MassachusettsIn collaboration with Clinical Sciences, Biostatistics, Clinical Operations, and other key Development functions, responsible for the design of clinical trial databases, which includes, but not limited to, CRF Development, Database Validation, and Data Review tools in accordance with ICH/GCP guidelines and current regulatory requirements. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Senior Director, Regulatory Affairs Bicara TherapeuticsSenior Director, Regulatory AffairsBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Principal ADS Program Lead GenentechPrincipal ADS Program LeadBoston, Massachusetts$136,400–$253,200 / yearIn addition to overseeing day-to-day delivery, the Analytical Data Science Program Lead is accountable for a broad range of analytical outputs including but not limited to: exploratory analyses, application development and dynamic visualization to enable ongoing data review and scientific insights generation. This role leads a team of highly skilled programmers and junior leaders, ensuring the delivery of high-quality, regulatory-compliant analytical outputs that support key development milestones and health authority submissions.
Clinical Scientist 2 or 3, Clinical Development Xenon PharmaceuticalsClinical Scientist 2 or 3, Clinical DevelopmentNeedham, MassachusettsThe clinical scientist will provide scientific leadership at the study level, contribute meaningfully to program strategy, and serve as a key partner to cross-functional teams to ensure that clinical development plans, study designs, and data packages are scientifically rigorous, operationally feasible, and aligned with evolving regulatory expectations. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Sr. Director, Regulatory Affairs Third Rock VenturesSr. Director, Regulatory AffairsCambridge, MA$245,000–$300,000 / yearThis individual will serve as a key cross-functional leader and regulatory expert, partnering closely with Program Leadership & Management, Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, CMC, Nonclinical, Quality, and Executive Leadership to advance innovative therapeutics through development and key regulatory milestones. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity.
Medical Device Complaint Trending Expert (Any Facility) Integra LifeSciences Holdings Corp.Medical Device Complaint Trending Expert (Any Facility)Mansfield, MA$81,650–$112,700 / yearThe individual partners cross functionally with Quality, Regulatory Affairs, Risk Management, R&D, Manufacturing, and Medical Safety to translate complex complaint data into actionable insights that support corrective and preventive actions (CAPA), regulatory submissions, and risk management decisions. The Medical Device Complaint Trending Expert is responsible for the end-to-end development, execution, and oversight of complaint data trending and signal detection activities to ensure timely identification of product quality, safety, and compliance risks.
Head of Statistical Programming Alexion Pharmaceuticals IncHead of Statistical ProgrammingBoston, MA$257,140–$385,711 / yearIn addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Accountabilities: Programming Strategy and Direction: Set the strategic direction for statistical programming within Quantitative Sciences, aligning therapy areas and enterprise priorities to deliver consistent, submission-ready outputs.
NewAssociate Director - Value, Access, Insights, and Solutions Takeda Pharmaceutical Co LtdAssociate Director - Value, Access, Insights, and SolutionsLexington, MA$169,400–$266,200 / yearDevelops and maintains a broad network of mutually supportive relationships with internal Takeda colleagues (Medical Product Teams, Medical Communications, VEG, Marketing, Managed Markets, Market Access Channel Strategy, Government External Affairs, Account Management and other affiliates) to ensure US Medical scientific and outcomes research and external affairs strategies are integrated across groups. How you will contribute: The Associate Director of Value Access Insights & Solutions is an integral member of the Marketing Content Enablement & Customer Engagement group and is responsible for: Serving as a partner to Product Medical Units, Medical Communications, Medical leads, Field Medical Leaders, Brand Teams, Market Access and Channel Strategy, Public Affairs and other Global and US internal stakeholders to ensure strategic alignment on cross-functional imperatives and initiatives.
Director of Clinical Affairs SonioDirector of Clinical AffairsBoston, Massachusetts$180,000–$200,000 / yearYour main missions are: Own clinical strategy end-to-end — translate Excom priorities into a roadmap of studies, claims, KOLs and communication, in partnership with the CSO; arbitrate clinical priorities across DS, RAQA, Marketing and Ops. Resulting from 5 years of collaboration between world-renowned experts from Necker Hospital and Ecole Polytechnique, Sonio uses artificial intelligence to improve prenatal screening and diagnosis.
Vice President, Quality Remix TherapeuticsVice President, QualityWatertown, MA$293,000–$358,000 / year469777815":"hybridmultilevel"}" data-aria-posinset="10" data-aria-level="1">Partner with Drug Safety/Pharmacovigilance to provide quality oversight of PV activities, including SAE reconciliation, SUSAR reporting, PBRER/DSUR quality review, and inspection readiness for safety databases and processes. ","469777815":"hybridmultilevel"}" data-aria-posinset="4" data-aria-level="1">Build and lead Remix's quality organization from the ground up; hire and develop a small, high-impact team while establishing the infrastructure, processes, and culture to scale alongside the pipeline.
Associate Director, Clinical Scientist Zenas BioPharmaAssociate Director, Clinical ScientistWaltham, MA$161,700–$202,200 / yearThis position works closely with Medical Directors to support medical monitoring activities, while partnering cross-functionally with Clinical Operations, Data Management, Biostatistics, Translational Sciences, Medical Affairs, and Regulatory Affairs to translate clinical strategy into operational deliverables and ensure rigorous ongoing review of trial data for quality, safety, and protocol compliance. Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody.
Senior Medical Director, Clinical Development DynamiCure BiotechnologySenior Medical Director, Clinical DevelopmentWaltham, MAYou will serve as an internal and external clinical leader, including interactions with key academic advisors, principal investigators, patient groups, regulatory authorities, academic and industry collaborators as well as DynamiCure’s senior management and Board of Directors. As a key contributor you will be a thought partner with the VP of Clinical Development for innovative oncology development strategies, as well as a collaborator with discovery, preclinical and translational researchers focused on development of novel vascular normalization and TME modulators.
Senior Director, Bioanalytical And Biomarker Development Editas MedicineSenior Director, Bioanalytical And Biomarker DevelopmentCambridge, MA$270,000–$300,000 / yearThis highly visible role will be accountable for the preclinical bioanalytical strategy, biomarker strategy, data quality, and regulatory readiness, ensuring successful EDIT-401 IND submission and Clinical Trial execution. As the Senior Director, Bioanalytical and Biomarker Development, you will: Lead assay development, qualification, validation, and execution for measuring drug product components, immunogenicity, biomarkers, and other analytes in biological matrices.
Bioinformatician / Bioinformatics Sanegene Bio USA IncBioinformatician / BioinformaticsWoburn, MAThis role will play a critical part in enabling data-driven decision-making through analysis, automation, pipeline development, data management, and cross-functional support for biology and platform teams. We are seeking a highly motivated Bioinformatician / Bioinformatics Scientist to support bioinformatics and operational workflows across discovery and translational research programs.
Director, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology)Boston, MAThis role is responsible for establishing and executing global safety strategy across early- and mid-stage clinical programs, with particular focus on immune-mediated toxicities, oncology risk management, and complex benefit-risk assessment. The Director of Drug Safety & Pharmacovigilance provides strategic and hands-on leadership for pharmacovigilance activities supporting a clinical-stage biotech pipeline in inflammatory and oncology diseases.
Clinical Trial Manager Centessa Pharmaceuticals PlcClinical Trial ManagerBoston, MA$120,000–$150,000 / yearDrive critical study milestones, including site activation, enrollment progress, patient retention, data cleaning, and database lock, proactively addressing operational challenges common to CNS trials. Lead day‑to‑day clinical trial operations, coordinating cross‑functional partners (Clinical Development, Data Management, Biostatistics, Regulatory, Safety) to ensure efficient trial execution and alignment to program objectives.
Executive Director, Clinical Development Centessa Pharmaceuticals PlcExecutive Director, Clinical DevelopmentBoston, MA$300,000–$375,000 / yearReporting directly to the Senior Vice President, Clinical Development, this leader will assume primary responsibility for the strategic and operational execution of the company's late-stage Orexin Receptor 2 Agonist Program (Program 750), which targets narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Strong knowledge in clinical development strategy, clinical trial design, regulatory pathways, biostatistics methodologies, and ability to analyze and interpret translational medicine, clinical, and research data as it relates to an asset, patients, etc.
Study Design Statistician (US) MMSStudy Design Statistician (US)Boston, MAFull timeWorking alongside innovative statisticians you will be responsible for leading the full life-cycle of KerusCloud support and statistical services, from: Assisting customers with their study design with a particular focus on simulation with KerusCloud to ensure they are aligned with the study objectives. As part of our Strategic Statistical Services Arm, this is a full-time role with emphasis on being an internal and external SME for clinical trial design, together with providing consultation to advise clients on a range of broader statistical issues, and will have an internal job title of Strategic Statistician .