Senior Director, Pharmacovigilance (PV) Process Lead 3316 Takeda Development Center AmericasSenior Director, Pharmacovigilance (PV) Process LeadCambridge, MassachusettsCultivates trusted, enterprise-wide relationships with key stakeholders across Takeda (e.g., Regulatory, Quality Assurance, Global Development Operations, Clinical Science, Medical Affairs, Commercial, Local Operating Companies, DD&T), demonstrating executive presence and strategic influence while serving as the central orchestrator to ensure strong PV oversight and performance , identifying risks, driving issue resolution, and promoting alignment and decision-making among cross-functional stakeholders. Champions technology and AI-enabled capabilities to drive continuous process improvement, operational excellence, and efficiency by streamlining the E2E processes, defining clear roles and responsibilities, and ensuring that they are in-line with regulatory requirements to maintain inspection readiness at all time.
Associate Director, Global Labeling Lead 3316 Takeda Development Center AmericasAssociate Director, Global Labeling LeadMassachusettsThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling and is: Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within PDT BU’s Global Labeling function, pertaining to pharmaceutical drug and device. In close collaboration with the Takeda R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance.
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, Enterprise Architecture Blue Cross and Blue Shield of Massachusetts IncDirector, Enterprise ArchitectureBoston, MA$202,050–$246,950 / yearAbout the Role: The Director of Enterprise Architecture is a senior technology leader responsible for defining and driving the overall technology strategy and architectural vision for Blue Cross Blue Shield of Massachusetts, with a focus on healthcare-specific systems, data, and regulatory requirements. An employee's pay position within the salary range will be based on several factors including, but limited to, relevant education, qualifications, certifications, experience, skills, performance, shift, travel requirements, sales or revenue-based metrics, and business or organizational needs and affordability.
Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product 3316 Takeda Development Center AmericasExecutive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination ProductBoston, MassachusettsAs Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance. Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances.
Senior Director, Clinical Pharmacology Amylyx Pharmaceuticals IncSenior Director, Clinical PharmacologyCambridge, MARemote$268,000–$302,000 / yearThe 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.
Senior Director, AI & Data Science - Claims & Fraud Liberty Mutual Holding Company IncSenior Director, AI & Data Science - Claims & FraudBoston, MAWe''re hiring a Senior Director to lead the data science and AI team supporting our Medical, SIU (Special Investigations Unit), and Programs (MSP) Claims organization and Central Fraud Hub, building the models, decisions, and tools that shape how we detect fraud, resolve claims, and serve customers at scale. You''ll set the AI strategy for the space, lead a team of 15 data scientists, and partner directly with senior claims and fraud leaders to turn AI capabilities into operational changes that move the numbers that matter.
Director, Pharmacovigilance Beam Therapeutics IncDirector, PharmacovigilanceCambridge, MA$210,000–$260,000 / yearWork closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents; leading cross functional teams to assess safety signals; preparing action and communication plans to mitigate/manage product risks; responding to safety related regulatory requests; developing and maintaining product risk management plans. The Director of Pharmacovigilance will contribute to a full range of pharmacovigilance activities including but not limited to the oversight and management of safety reports and safety data, signal management activities, PV organization and process development, inspection readiness, PV vendor management, and operational support for Beam products throughout the lifecycle.
Executive Director, Head of Strategic Market Insights Ionis Pharmaceuticals IncExecutive Director, Head of Strategic Market InsightsBoston, MARemote$230,000–$265,000 / yearWith multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. Lead, develop, and inspire a high performing market insights team of individual contributors and people leaders; attract, hire, and onboard new talent as appropriate, and build a team that is known for rigorous thinking, extreme attention to detail, pace, and the ability to see patterns and implications others may miss.
Director - Financial Due Diligence RSM US LLPDirector - Financial Due DiligenceBoston, MA$151,200–$304,200 / yearIf you are a recent U.S. college / university graduate possessing 1-2 years of progressive and relevant work experience in a same or similar role to the one for which you are applying, excluding internships, you may be eligible for hire as an experienced associate. The salary range (or starting rate for interns and associates) for this role represents numerous factors considered in the hiring decisions including, but not limited to, education, skills, work experience, certifications, location, etc.
Director of Regulatory Compliance & Validation Strategy LumafieldDirector of Regulatory Compliance & Validation StrategyCambridge, MA$160,000–$190,000 / yearLumafield's Quality Leader will own the Quality Management System across all of Lumafield: design and development planning, hardware manufacturing, software, cloud services, metrology and measurement, field service, and our customer-facing applications engineering and scan lab operations. Deliver approach for a validated solution: Advise on and provide leadership to Product and Engineering for Lumafield to provide fully validated solutions to our customers in regulated industries.
Director of Revenue Cycle VITRA HealthDirector of Revenue CycleBoston, MAPartner with the Compliance function on all billing-related matters, ensuring that MassHealth Adult Foster Care (AFC) and Group Adult Foster Care (GAFC) billing practices adhere to 130 CMR 408.000 and 130 CMR 450.000, including conditions for payment, prior authorization, non-covered days, medical and nonmedical leave-of-absence limits, and supporting documentation requirements, and engage Compliance in the review of billing policies, void and adjustment activity, and any identified billing irregularities. Requires lifting and carrying equipment and supplies weighing up to 35 pounds; requires pushing and pulling equipment and supplies weighing up to 35 pounds; requires walking and standing; requires frequent sitting more than 75% of the workday; requires the ability to negotiate stairs; requires visual acuity and manual dexterity to operate equipment.
Associate Director, Environmental Health & Safety Terrestrial Bio IncAssociate Director, Environmental Health & SafetyWoburn, MA$140,000–$170,000 / yearCommunication & Judgment: Strong writing and training delivery, comfort moving between program strategy and hands-on execution, and the ability to work across two Greater Boston sites. Risk, Incident & Emergency Response: Formalize risk assessment, job hazard analysis, incident investigation, root cause analysis, and near-miss reporting under a just-culture framework; own fire, spill, and evacuation planning.
Associate Director, Omnichannel Brand Partner Swedish Orphan Biovitrum ABAssociate Director, Omnichannel Brand PartnerWaltham, MA$150,000–$190,000 / yearThis individual will collaborate closely with marketing, agency partners, analytics, and a broad range of other stakeholders to support the design and delivery of digital and omnichannel experiences, digital media, and digital analytics, including dedicated support for two upcoming Immunology launch brands. The team member will have the opportunity to influence omnichannel activity aligned with the broader vision of enhancing customer experience (CX) across patients, caregivers, and HCPs, bringing deep knowledge of the customer journey and a sharp eye for identifying the moments that matter most.
Executive Director, Oncology Translational Medicine, Clinical Pharmacology Modeling and Simulation GSK plcExecutive Director, Oncology Translational Medicine, Clinical Pharmacology Modeling and SimulationWaltham, MAWe have an exciting opportunity at GSK for a highly motivated and experienced Executive Director to join our team supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. This role focuses on delivering CPMS excellence to research and development programs, helping to accelerate the development of innovative oncology therapies by ensuring they reach the right patients, at the right dose, and at the right time.
Director, Clinical Research Operations WhoopDirector, Clinical Research OperationsBoston, Massachusetts$210,000–$230,000 / yearLead operational oversight of CROs, technology vendors, recruitment partners, and other external service providers, establishing scalable governance frameworks, performance metrics, and escalation pathways to ensure high-quality delivery and accountability. Oversee Clinical Data Management and clinical trial technologies, ensuring high-quality, timely, and compliant data collection, management, and delivery across systems including EDC, CTMS, eConsent, ePRO, eTMF, and remote study platforms.
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).
Director US Advertising And Promotion Global Regulatory Affairs SanofiDirector US Advertising And Promotion Global Regulatory AffairsCambridge, MA$178,500–$257,833.33 / yearThe Director is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs. About the job: As the Director, US Advertising and Promotion, Global Regulatory Affairs within our GRA Advertising and Promo Team, you will be responsible for decisions, providing strategic direction and oversight for the day-to-day activities for assigned products.
Sr. Director, Regulatory Strategy Genetix BiotherapeuticsSr. Director, Regulatory StrategySomerville, Massachusetts$265,000–$331,000 / yearThe successful candidate must have strong written and oral communication skills and have experience writing regulatory briefing documents, leading meetings with health authorities, and partnering with regulatory agencies to advance complex therapies (experience with cell or gene therapies is preferred.) An additional key responsibility will be working to develop and execute the regulatory roadmap to support future European Union submissions for existing products, including regulatory gap assessments, EU engagement strategy, pediatric planning, and preparation for Marketing Authorization Applications (MAAs).
Director Market Development SanofiDirector Market DevelopmentCambridge, MA$178,500–$257,833.33 / yearDemonstrated ability to work effectively with cross-functional groups which may include Marketing, Global Marketing, Sales, Research & Development, Medical Affairs, Business Development, Market Research, Life Cycle Management and Finance. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases andblood disorders, cancers, and neurological disorders.