Senior Director, Analytical Development Generate BiomedicinesSenior Director, Analytical DevelopmentSomerville, MassachusettsReporting to the Vice President, Technical Operations, this leader will shape the future analytical operating model for Generate’s biologics portfolio, including analytical strategy, method lifecycle management, release and stability testing, specifications, comparability, external analytical operations, GMP readiness, and commercialization preparation across CDMO and contract testing partners. The Senior Director will serve as the senior analytical partner to CMC, Process Development, MS&T, Quality, Regulatory, Supply Chain, and external partners, ensuring protein therapeutics are supported by phase-appropriate, scientifically rigorous, inspection-ready analytical control strategies that advance key company objectives and enable late-stage development and commercialization readiness.
Director, Global Trade TA Instruments IncDirector, Global TradeMilford, MAWe collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Position Summary The Director, Global Trade Compliance & Trade Operations is a senior enterprise leader responsible for defining and advancing the company's global trade strategy, integrating regulatory compliance with world-class import/export operations.
Assistant Human Resources Officer (Senior Strategic Business Partner) U.S. Department of Veterans AffairsAssistant Human Resources Officer (Senior Strategic Business Partner)Bedford, MA$106,437–$163,514 / yearQualifying education for the GS-0201 series includes courses and programs in HR, HR development, HR management, business, business management/administration, industrial relations, labor relations, industrial psychology, organizational psychology, organizational development, management, organizational behavior, pre-law/law, legal studies, health care management/administration, public administration, public policy, human services, leadership and/or humanities. Examples of specialized experience would typically include, but are not limited to: Directing and reviewing Human Resources functional programs (position management, compensation, staffing, employee & labor relations, processing & records, personnel security); Serving as an expert advisor to top management on personnel laws, regulations, functions, policies, and procedures; Reviewing newly issued regulations/directives and interpreting for incorporation into local policy; Representing the facility at various hearings/arbitrations.
Director, Oncology Translational Medicine GSK plcDirector, Oncology Translational MedicineWaltham, 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. Supporting disease area strategies and translational objectives by defining biomarker priorities, areas of interest, and generating decision-enabling evidence packages informed by real-world datasets, internal and external data and partnerships (For e.g., research collaborations, KEE consultations).
Medical Education Manager AngioDynamics IncMedical Education ManagerBoston, MAAngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care. The role serves as a strategic partner to Medical Affairs, Clinical Affairs, Marketing, and Commercial leadership to translate clinical evidence into impactful educational initiatives that improve physician competency, confidence, and patient outcomes.
Director, Country Operations Management AstraZeneca PlcDirector, Country Operations ManagementBoston, MA$162,566.40–$243,849.60 / yearEnsuring cross-functional collaboration of team and PMCOs through proactive communication with global study team members (Global Study Directors, Global Study Associate Directors, Global Study Managers), and other local study team members (Study Start-up Managers, Site Contract Associate Directors, Site Alliance Lead, Site Solutions Manager, CRAs, and ADCOM) to raise and resolve study specific blockers quickly. The DCOM is a key contributor in the overall deliverables for the country, including early planning, feasibility, site selection, study start-up, enrollment, data deliverables, and close-out, and works in partnership with global study team, SDHCO, Dir SSU and Site Partnership, and RHCO to define those deliverables.
Evidence Generation Operations & Compliance Director 3316 Takeda Development Center AmericasEvidence Generation Operations & Compliance DirectorMassachusettsPartner closely with Global Evidence Generation Strategy & Operations and Clinical Science and Study Operations Group to identify opportunities to modernize evidence generation operations through emerging technologies, intelligent workflow design, advanced analytics and responsible AI solutions that improve compliance, efficiency, documentation quality, oversight effectiveness and user experience. Serves as the primary Medical Governance Office lead for evidence generation operations, ensuring consistent governance, oversight, quality, risk management and inspection readiness across Medical-led research activities while partnering with R&D Quality Assurance as the enterprise quality authority for applicable GxP research activities.
Sr Sterility Assurance Scientist Integra LifeSciences Holdings Corp.Sr Sterility Assurance ScientistMansfield, MA$71,000–$98,000 / yearThe Sterility Assurance Scientist is responsible for supporting activities that maintain compliance to the applicable regulations (FDA, Canadian Medical Device Regulations (CMDR), European Medical Device Regulation (EU MDR), ISO 13485, and ISO 9001) as they apply to sterilization. Collaborates with Subject Matter Experts from other departments (i.e. Design Quality Engineering) to ensure a comprehensive approach to bring new and changed product into production.
Sr Sterility Scientist Integra LifeSciences Holdings CorpSr Sterility ScientistBraintree, MA$71,000–$98,000 / yearThe Sterility Assurance Scientist is responsible for supporting activities that maintain compliance to the applicable regulations (FDA, Canadian Medical Device Regulations (CMDR), European Medical Device Regulation (EU MDR), ISO 13485, and ISO 9001) as they apply to sterilization. Collaborates with Subject Matter Experts from other departments (i.e. Design Quality Engineering) to ensure a comprehensive approach to bring new and changed product into production.
Sr. Sterility Assurance Scientist Integra LifeSciencesSr. Sterility Assurance ScientistMassachusettsThe Sterility Assurance Scientist is responsible for supporting activities that maintain compliance to the applicable regulations (FDA, Canadian Medical Device Regulations (CMDR), European Medical Device Regulation (EU MDR), ISO 13485, and ISO 9001) as they apply to sterilization. Collaborates with Subject Matter Experts from other departments (i.e. Design Quality Engineering) to ensure a comprehensive approach to bring new and changed product into production.
Medical Director, Clinical Development, Hepatology GSK plcMedical Director, Clinical Development, HepatologyWaltham, MA$222,750–$371,250 / yearThese responsibilities include some of the following: Contribute to project team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc) to support vital deliverables including the Target Product Profile (TPP), clinical development plan (CDP), study protocols, and integrated evidence strategy (IES) and planning. Act as clinical lead for a clinical study, taking a key role on the Study Leadership Team (SLT) and serve as clinical point of contact for a clinical study on the Clinical Matrix Team (CMT), across the internal matrix and a broad range of external experts (e.g., regulators, payors, CROs, consultants, investigators).
Clinical Scientist, Neuroimmunology & Specialty Care, PDT Takeda Pharmaceutical Co LtdClinical Scientist, Neuroimmunology & Specialty Care, PDTBoston, MA$116,000–$182,270 / yearThis role will work within the Neuroimmunology and Specialty Care team to support development of clinical assets across the United States, the European Union, and Japan, including protocol concept and protocol development, study start-up and execution, data cleaning, preparation of clinical study reports, and contributions to regulatory filings. Proven experience preparing clinical study protocols, Clinical Study Reports, integrated clinical statistical reports, and clinical sections for regulatory submissions across multiple regions, including Investigational New Drug and New Drug Application documentation.
NewAssociate Director, Data Architect Amylyx PharmaceuticalsAssociate Director, Data ArchitectCambridge, MARemoteThis individual will play a key role in building a scalable, modern data ecosystem centered on Snowflake, enabling trusted, high-quality data across Commercial, Medical Affairs, Patient Services, Finance, R&D, Quality, and Corporate functions. Design and oversee integration of key commercial data sources including: CRM, Specialty Pharmacy, Specialty Distributor, Patient Services, Claims and Prescription Data, Formulary and Market Access Data, Customer Master Data, etc.
Medical Affairs/Safety - Manager, PV Scientist TalentBurst, Inc.Medical Affairs/Safety - Manager, PV ScientistCambridge, MA$113.55 / hourCollaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
Principal Market Development Manager - Environmental and Materials Science Waters CorporationPrincipal Market Development Manager - Environmental and Materials ScienceMilford, MassachusettsRemotePartner with corporate marketing and field sales teams to implement regionally relevant marketing campaigns, demand generation initiatives (seminars, webinars, user meetings, customer visits) and strategic messaging. The role spans the Waters total portfolio including instruments, consumables and application-specific offerings with a focus on environmental and materials science testing, regulatory compliance, and sustainability-driven market trends.
Asst General Counsel II Fresenius Medical CareAsst General Counsel IIWaltham, MassachusettsExperience drafting, reviewing and negotiating complicated commercial contracts and dealing with the rules and regulations applicable to health care companies, including, but not limited to, HIPAA, data security matters, telemedicine, corporate practice of medicine, and fraud and abuse. Conduct legal research and interpret laws, rules, and regulations on a wide range of healthcare topics, including HIPAA, telehealth, professional licensure/oversight and provide practical guidance to internal stakeholders with Interwell’s goals and values in mind.
Executive Director, Clinical Development Lead Kiniksa PharmaceuticalExecutive Director, Clinical Development LeadLexington, MAResponsibilities (including, but not limited to): Serve as the clinical lead on cross-functional development program teams to develop and execute the overall clinical development strategy for assigned programs, in collaboration with key stakeholders and leadership, while providing scientific and medical input into target product profiles, development plans, and lifecycle strategies. Ensure internal study teams, investigators and site personnel, and external vendors are trained on clinical trial design and rationale, and provide support for data management activities, including development of case report forms, review of protocol deviations, and resolution issues.
Senior Director, Chief Privacy Lead ZOLL MedicalSenior Director, Chief Privacy LeadChelmsford, MassachusettsRemoteThis leader partners closely with senior executives and cross-functional stakeholders across Legal, Regulatory Affairs, IT, Cybersecurity, R&D, Clinical, Quality, Commercial, Human Resources, and Operations to embed privacy-by-design and data protection principles into products, software-enabled medical technologies, connected devices, business processes, and enterprise systems. The CPL is responsible for leading and continuously evolving a comprehensive global privacy governance framework to ensure compliance with international, federal, and state privacy and data protection laws and regulations, including GDPR, HIPAA, consumer health privacy laws, cross-border data transfer requirements, and emerging digital health and AI-related regulatory frameworks.
Global Head, Science Partnerships And Funding (Spf), Vaccines R&D SanofiGlobal Head, Science Partnerships And Funding (Spf), Vaccines R&DWaltham, MA$232,500–$335,833.33 / yearDevelop and implement the Sanofi Vaccines global external partnership strategy across the entire value chain (Research to Industrialization): Engage effectively key internal stakeholders (from various organizations such as R&D, Vaccine Manufacturing & Supply, Vaccine Portfolio Strategy, Vaccines GBU Executive Committee members) in order to articulate and validate the priority gaps and needs for external partnerships and external financing and to define unambiguously the metrics of success of such partnerships. Develop and execute robust processes and stakeholder engagement for partnership submission and administration: For grant submissions, oversee the responses to Request-For-Proposals (RFPs) from external funding agencies by mobilizing and collaborating with multiple Sanofi partners (Business Development, Intellectual/Legal, R&D functions, Global Project Heads, Manufacturing & Supply, Finance, etc) to deliver high-quality proposals and budgets.
NewAcademic Success Advisor University of Massachusetts AmherstAcademic Success AdvisorAmherst, MAUnder the general supervision of the Director of Advising and Academic Success in the School of Public Health & Health Sciences (SPHHS), this school level position provides comprehensive advising for university undeclared and exploratory track students; implements and coordinates programs and services to promote the academic success of undergraduate at-risk students; works closely with departmental advisors with particular emphasis on first-year and at-risk students; provides 4+1 advising for undergraduate students moving into graduate study; and is responsive to the needs of a large number of highly diverse students. Work with campus departments to keep up to date with various policy/procedural changes relevant to advising, campus-wide initiatives affecting student services and advising and informing new school and campus policies to (department) advisors and providing training and support when necessary.