Director, Global Regulatory Labeling Strategy 3316 Takeda Development Center AmericasDirector, Global Regulatory Labeling StrategyMassachusettsRemoteConducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.
Director of Health Economics & Outcomes Research (HEOR) WhoopDirector of Health Economics & Outcomes Research (HEOR)Boston, MassachusettsAt WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company’s long-term growth and success. Leverage WHOOP’s existing longitudinal member dataset to design and execute real-world evidence analyses demonstrating health impact, productivity gains, utilization reduction, or risk stratification value.
Associate Director, Clinical Data Management X4 Pharmaceuticals IncAssociate Director, Clinical Data ManagementBoston, MAThe Associate Director will oversee CRO partners and vendors, drive data quality and inspection readiness, support regulatory submissions, and ensure the timely delivery of high-quality clinical trial data. Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options?
Director, Clinical Data Management Stoke Therapeutics, Inc.Director, Clinical Data ManagementBedford, MA$225,000–$244,000 / yearRequired Skills & Experience: Bachelor's degree or higher in a scientific or healthcare discipline (advanced degree a plus), with 10+ years of progressive experience in data management within biotech, pharmaceutical, or CRO settings, including prior line-management / people leadership experience. In depth knowledge of clinical data management systems (eg: Medidata Rave Veeva Vault CDMS) required; working familiarity with data review, visualization, and analytics tools (e.g., SAS, R/Python, Spotfire, Power BI, J-Review, or elluminate).
Executive Director, Patient Advocacy & Engagement Stoke Therapeutics, Inc.Executive Director, Patient Advocacy & EngagementBedford, MA$296,000–$311,000 / yearDevelop and deliver on an annual plan aligned to corporate and department goals, including developing and tracking KPIs and metrics to measure the success of advocacy initiatives; continually innovate and elevate Stoke's approach to patient advocacy and engagement by continuously learning and staying current with best practices. Partner effectively with Product & Corporate Communications, Medical Affairs and Clinical Operations to ensure timely, consistent and compliant communication and responses to external patient inquiries about our programs, including clinical trials and access.
Senior Director, Clinical Pharmacology Amylyx PharmaceuticalsSenior Director, Clinical PharmacologyCambridge, MA - RemoteRemoteThe Senior Director, Clinical Pharmacology is a highly experienced clinical pharmacologist who will provide strategic scientific leadership across multiple development programs from Phase 1 through Phase 3. Reporting to the Vice President, Clinical Pharmacology, this individual will partner with cross-functional program teams to develop and execute clinical pharmacology strategies that support regulatory submissions and successful drug development. The successful candidate will work collaboratively with Clinical Development, Biometrics, Regulatory Affairs, Translational Medicine, Nonclinical, Medical Writing, and external partners to ensure robust clinical pharmacology strategies throughout development.
Director, Training Strategy & Process Enablement ModernaTXDirector, Training Strategy & Process EnablementCambridge, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. The Director will establish scalable frameworks for role-based learning, change management, training effectiveness, and knowledge management while driving innovation in learning methodologies, digital learning technologies, and organizational capability development.
Associate Director, SAP Internal Warehouse and Serialization ModernaTXAssociate Director, SAP Internal Warehouse and SerializationNorwood, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is seeking an Associate Director – SAP Internal Warehousing and Serialization to lead the strategy, roadmap, delivery, and support of the digital capabilities supporting internal warehousing and pharmaceutical serialization.
Director, Employee Relations & HR Compliance Multiple locations · Hybrid MooveDirector, Employee Relations & HR Compliance Multiple locations · HybridBoston, MABy partnering with industry leaders-including world-class OEMs, top tech providers, and key autonomous mobility pioneers like Waymo-we ensure that high-performance vehicle fleets are deployed with surgical precision, safety, and peak efficiency. Oversee global mobility and immigration compliance, managing visa sponsorship, work authorization verifications (e.g., Form I-9/E-Verify and statutory right-to-work checks), and vendor relationships with external immigration counsel.
Director, Customer Experience Operations Paperless PartsDirector, Customer Experience OperationsBoston, MABy pairing strong analytical capabilities with execution-focused leadership, you will turn operational data into actionable strategies that drive capacity, customer retention, and functional consistency across the entire CX organization. Resource & Capacity Planning: Lead workforce planning, utilization tracking, backlog management, and services forecasting by linking Sales pipelines to delivery capacity.
Director of Operations - Industrial Manufacturing Michael Page InternationalDirector of Operations - Industrial ManufacturingChelmsford, Massachusetts$170,000–$180,000 / yearFull timeExperience within Electronics Manufacturing Services (EMS), contract manufacturing, electronics assembly, aerospace & defense, medical device, or other regulated manufacturing sectors highly preferred. Serving a diverse customer base across complex manufacturing sectors, the organization has built a strong culture centered on collaboration, accountability, and continuous improvement.
Director, Global Regulatory Affairs Stoke Therapeutics, Inc.Director, Global Regulatory AffairsBedford, MA$248,000–$280,000 / yearPosition Purpose: The Director, Global Regulatory Strategy will be responsible for developing and delivering global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and in alignment with the corporate strategy for Stoke's portfolio. Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.
Human Factors And Usability Engineering Director SanofiHuman Factors And Usability Engineering DirectorCambridge, MA$178,500–$257,833.33 / yearThe Director owns significant responsibilities across the full product lifecycle from early-stage user needs through Lifecycle Management (LCM) and is highly relied upon to lead the most complex, high-stakes programs while advancing HF/UE as a strategic differentiator across the organization, strengthening how user-centered thinking shapes decisions from early concept through launch. Deep expertise in the full HF/UE lifecycle: user needs, use requirements, context of use, Known Use Problems (KUPs), Use-Related Risk Analysis (URRA), generative/formative/summative study design and execution, Usability Engineering File (UEF)/Design History File (DHF) documentation, and regulatory submission strategy.
Senior Director, Regulatory Affairs Strategy - Cell Therapy AstraZeneca PlcSenior Director, Regulatory Affairs Strategy - Cell TherapyBoston, MA$218,058–$327,087 / yearGlobal Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.
Executive Director Clinical Operations, Program Management (Cell Therapy) AstraZeneca PlcExecutive Director Clinical Operations, Program Management (Cell Therapy)Cambridge, MA$270,188.80–$405,283.20 / yearAccountabilities: Franchise Leadership: Clinical Operations Strategy: Define and implement short- and long-term clinical operations strategies across franchises, including therapeutic operating models, country footprint and site strategies, and consistent, deliverable operational clinical development plans. Cross-Functional Integration: Build deep partnerships with shared functions (Data Management, Vendor Management, Lab Management groups, Logistics, Manufacturing) to co-create and execute fit-for-purpose cell therapy strategies.
Director, IT R&D And Quality Applications Amylyx PharmaceuticalsDirector, IT R&D And Quality ApplicationsCambridge, MARemote$206,000–$232,000 / yearAdditional responsibilities will include a range of activities within the information technology organization including project management, development, and maintaining procedures to ensure Amylyx has a stable, robust, and scalable set of applications to support the changing business needs and support. If outside of the New England region, you will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation.
NewDirector/Sr. Director, US Regulatory Advertising and Promotion Genetix BiotherapeuticsDirector/Sr. Director, US Regulatory Advertising and PromotionSomerville, Massachusetts$185,000–$285,000 / yearThe Director serves as a key regulatory partner to Medical Affairs, Commercial, Marketing, and Legal, and plays a central role in promotional material review in a highly regulated environment, for cell and gene therapy products. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
Cell Therapy Strategy and Commercial Executive Director AstraZeneca PlcCell Therapy Strategy and Commercial Executive DirectorCambridge, MA$267,914–$401,870 / yearYou will lead global commercial and strategic initiatives within the Cell Therapy Enterprise CTU)-including business development and competitive intelligence-partnering with Therapeutic Areas on clinical strategy, collaborating with in-market commercial and medical affairs on launch readiness, and aligning with global pricing and brand teams. The Strategy and Commercial Executive Director, Cell Therapy Strategy and Commercial (CTSC), is a high-impact leadership role accountable for shaping and driving the end-to-end strategy for a defined indication or disease area within Cell Therapy.
Director, Oncology Translational Medicine Project Manager GSK plcDirector, Oncology Translational Medicine Project ManagerWaltham, MA$189,750–$316,250 / yearAnalytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations. The Director, Oncology Translational Medicine Project Manager, will provide high-quality project management support to the delivery of OTM strategic initiatives, and to the OTM Leadership Team, including the Clinical & Translational Biomarkers, Precision Diagnostics, and Clinical Pharmacology Modelling and Simulation (CPMS) divisions.
Director, R&D AI & Technology Adoption GSK plcDirector, R&D AI & Technology AdoptionWaltham, MA$170,775–$284,625 / yearAI Adoption, Behavior Management, Change Management, Change Process Management, Communication, Cross-Departmental Collaboration, Decision Making, Financial Acumen, Innovation, Leadership, Management of Change, Portfolio Management, Project Management, Project Management Governance, Risk Management, Stakeholder Engagement, Stakeholder Management, Strategic Leadership, Technology Transformation, Visionary Thinking. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.