Assistant Director of Sterile Processing and Clinical Support Operations - School of Dental Medicine Tufts UniversityAssistant Director of Sterile Processing and Clinical Support Operations - School of Dental MedicineBoston, MassachusettsSterile Processing and Clinical Support Operations Leadership Oversees the daily operations of the Central Sterilization Facility and provides senior operational leadership for sterile processing functions and associated clinical support workflows across the dental school. What You'll Do: The Assistant Director of Sterile Processing and Clinical Support Operations provides strategic and operational leadership for the Central Sterilization Facility and related clinical support workflows within Tufts University School of Dental Medicine.
Senior Director, AIRx Medicinal Chemistry 3316 Takeda Development Center AmericasSenior Director, AIRx Medicinal ChemistryBoston, Massachusetts$212,000–$333,190 / yearThe 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. Takeda Research is constructing the Discovery Automation & Robotics (DAR) group built on AI, automation, new ways of working, and talent with the singular vision of delivering differentiated medicines to the clinic at speed and cost.
Associate Director, Clinical Quality Compliance Stoke Therapeutics, Inc.Associate Director, Clinical Quality ComplianceBedford, MA$192,000–$215,000 / yearThis person will support Stoke's clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all Stoke clinical and bioanalytical studies. This person will be responsible for establishing Stokes inspections management program for GCP inspections and expected to be influential towards maturing Stoke's quality culture and help reach a sustained state of inspection readiness.
Director Of Global Customer Operations & Fulfillment Boston Dynamics, inc.Director Of Global Customer Operations & FulfillmentWaltham, MA$195,000–$255,000 / yearServing as the "Direct Responsible Individual (DRI) of Fleet Stability," you will lead our end-to-end technical support (Tiers 1-3), mobile field support engineers, brick-and-mortar depot repair operations, RMA pipelines, serviceability/quality engineering liaison, and global 3PL/4PL customer logistics fulfillment network. You will optimize internal workflows to resolve customer issues rapidly, drive down the overall cost-to-serve, build dynamic parts availability, and ensure engineering teams design future robots to be easily serviced and maintained.
Director, Clinical Monitoring Strategy and Oversight ModernaTXDirector, Clinical Monitoring Strategy and OversightCambridge, MassachusettsThe Director serves as the functional leader for monitoring strategy, integrating risk-based monitoring (RBM), centralized monitoring, remote monitoring, and emerging digital capabilities into a scalable oversight framework for both insourced and outsourced monitoring strategies. We 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.
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, Head of PV Operations Oversight 3316 Takeda Development Center AmericasExecutive Director, Head of PV Operations OversightBoston, MassachusettsThis role is accountable for the operational performance of global case processing, Individual Case Safety Report (ICSR) management, regulatory reporting, tracking of market research / patient support programs (MR / PSP), performing PV review and approval of digital assets and social media programs before launch, and oversight of pharmacovigilance service providers. Oversee pharmacovigilance activities related to case intake, case processing, medical coding, triage, quality review, Individual Case Safety Reports (ICSRs), regulatory reporting, market research programs, patient support programs, and Takeda-sponsored digital assets and social media initiatives.
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.
Director, (Alpha-1 Antitrypsin Deficiency) Aatd Patient Support Services Strategy And Operations SanofiDirector, (Alpha-1 Antitrypsin Deficiency) Aatd Patient Support Services Strategy And OperationsCambridge, MA$178,500–$257,833.33 / yearThe role encompasses strategic design of the AATD patient services model, launch readiness, and ongoing operational performance - partnering closely with the Head of Rare Disease PSS on development and performance of the PSS strategy and Field Education and Case Management teams. Lead vendor strategy, performance, and quality oversight (financial assistance, copay, access technology, market research, etc.) in partnership with Centers of Excellence, identifying partners and ensuring delivery against contracted SLAs.
Director Of Brand Strategy & Commercial Integration - Patient Support Services, Rare Hem And Oncology SanofiDirector Of Brand Strategy & Commercial Integration - Patient Support Services, Rare Hem And OncologyCambridge, MA$178,500–$257,833.33 / yearThis individual serves as the primary point of contact to Brand Leadership, owns the annual brand planning cycle for patient support programs, leads commercial messaging strategy across all touchpoints, and drives Plan of Action (POA) planning to ensure cross-functional alignment. Partners with content operations & asset management leads on messaging execution and HemAssist and CareAssist content development - this role owns messaging strategy; content operations & asset management leads owns content execution and pull-through.
Director, Hospital Operations – Spine 6029-MEDICAL DEVICE BUSINESS SERVICES Legal EntityDirector, Hospital Operations – SpineRaynham, MassachusettsAs a key member of the commercial operations leadership team, the Director will partner closely with Sales, Marketing, Supply Chain, Finance, and Global Operations leaders to drive strategic initiatives, enhance business performance, and build scalable operational capabilities. Business Alignment, Coaching, Collaboration, Consulting, Efficiency Analysis, Marketing Integration, Market Savvy, Process Optimization, Project Management, Sales Enablement, Sales Support, Sales Training, Solutions Selling, Tactical Planning, Technical Credibility
Sr. Director, Clinical Outsourcing and Vendor Management City TherapeuticsSr. Director, Clinical Outsourcing and Vendor ManagementCambridge, MassachusettsReporting to the Vice President of Clinical Operations, this individual will serve as the primary business owner for key clinical vendors, including CROs, central laboratories, imaging providers, eCOA/ePRO vendors, IRT providers, and specialty service partners. The successful candidate will establish scalable vendor governance processes, ensure operational excellence, and drive accountability across external partnerships while supporting the execution of City's clinical development programs.
Associate Director, Quantitative Systems Pharmacology GSK plcAssociate Director, Quantitative Systems PharmacologyWaltham, MA$151,500–$252,500 / yearAs an Associate Director of Quantitative Systems Pharmacology (QSP) Expert, you will develop and apply QSP models to guide clinical study designs and mechanistic interpretation of study results in support of development of treatments and combination of treatments for a variety of diseases and therapeutic areas. This role requires a highly motivated individual to develop and apply QSP models to guide clinical study designs and mechanistic interpretation of study results in support of development of treatments and combination of treatments for a variety of diseases and therapeutic areas.
Assistant Director, Sales & Operations Execution Planning Ionis Pharmaceuticals IncAssistant Director, Sales & Operations Execution PlanningBoston, MA$97,090–$141,725 / 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. This role acts as the primary operational liaison between internal stakeholders and external manufacturing and supply partners, driving execution excellence across supply planning, vendor management, material flow, and issue resolution.
Associate Director, Market Development SanofiAssociate Director, Market DevelopmentCambridge, MA$148,500–$214,500 / yearThe Associate Director, Market Development for the Frexalimab Global Franchise supports and executes integrated market development and disease education strategies to support best-in-class commercialization of frexalimab in Multiple Sclerosis, with potential for future expansion across additional indications. Partner with Global Market Development Lead MS, Global Brand Lead, Global Cross indication lead, Global Medical, Training, and Regional Marketing to deliver unbranded peer-to-peer education and speaker programs, ensuring consistent non-promotional narratives across all HCP touchpoints.
Regulatory Affairs Strategy Director AstraZeneca PlcRegulatory Affairs Strategy DirectorBoston, MA$186,232.80–$279,349.20 / yearCompetitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
Associate Director, MFG Training, Compliance and OpEx EyePoint IncAssociate Director, MFG Training, Compliance and OpExnorthbridge, MA$150,380–$190,207 / yearThe Associate Director, MFG Training, Compliance and OpEx will report to the VP Manufacturing and Operational Excellence and will lead the strategic design, implementation, and continuous improvement of manufacturing training programs, regulatory compliance frameworks, and Operational Excellence (Opex) initiatives. Primary skills and knowledge required include, but are not limited to the following: Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority.
Director, Clinical Pharmacology Modelling and Simulation (CPMS) Oncology GSK plcDirector, Clinical Pharmacology Modelling and Simulation (CPMS) OncologyWaltham, MA$188,100–$313,500 / yearWe are seeking professionals with the following required skills and qualifications to help us achieve our goals: PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modeling/simulation to solve practical problems in industry or academia. 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.
Associate Director, Manufacturing Operations EyePoint IncAssociate Director, Manufacturing OperationsNorthbridge, MA$150,000–$190,207 / yearThe Associate Director serves as a key member of the Operations leadership team and partners closely with Quality, Engineering, Supply Chain, Regulatory, and Product Development functions to drive operational excellence, maintain inspection readiness, and support company growth objectives. The Associate Director, Manufacturing is responsible for the leadership, strategic planning, and operational execution of manufacturing activities supporting the production of GMP-regulated combination products.
Senior Director, Pharmacokinetics, Dynamics, Metabolism and Bioanalysis, Protein Therapeutics Merck & Co IncSenior Director, Pharmacokinetics, Dynamics, Metabolism and Bioanalysis, Protein TherapeuticsBoston, MA$194,100–$305,600 / yearRequired Skills: ADME, Assay Development, Bioanalysis, Bioanalytical Assays, Bispecific Antibodies, Communication, Cross-Cultural Awareness, Drug Discovery Development, Drug Metabolism, Fast-Paced Environments, Immunology, Immunotherapy, Innovation, Ligand Binding Assay, Modeling Simulations, Monoclonal Antibodies, Oncology, People Leadership, Pharmacokinetics, PKPD Modeling, Protein Engineering, Results-Oriented, Scientific Leadership, Strategic Thinking, Therapeutic Proteins. The successful candidate will lead a group of principal investigators and subject matter experts and will be expected to collaborate cross-functionally with discovery biologics, nonclinical drug safety, translational medicine and therapeutic area colleagues to ensure robust program strategies from early discovery through to IND submission and beyond.