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.
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.
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.
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).
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.
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.
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.
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.
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.
Clinical Trials Project Manager CareerscapeClinical Trials Project ManagerBoston, MA$95,000–$125,000 / yearContractorOur client, a biopharmaceutical company based in Boston, is seeking a Clinical Trials Project Manager to oversee the execution of Phase II and Phase III clinical studies. This is a hybrid contract role based in Boston, with on-site presence required for study team meetings, site initiation visits, and sponsor audits.
Principal Quality Engineer Katalyst Healthcares & Life SciencesPrincipal Quality EngineerCambridge, MAThe ideal candidate will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance while partnering with cross-functional teams to drive operational excellence. We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product development processes.
Senior Engineer II, Device Development BiogenSenior Engineer II, Device DevelopmentCambridge, MassachusettsBachelor’s degree in biomedical, electrical, mechanical, or related engineering discipline with at least 6 years of experience in device and/or combination product development, including 3+ years of experience with drug delivery and combination products such as autoinjectors, pre-filled syringes, wearable injectors, pen injectors, or drug reconstitution devices. This role will support both new product development and sustaining engineering for marketed products by applying rigorous science and engineering, evaluating emerging technologies, and partnering with internal and external stakeholders to advance optimized delivery systems for Biogen’s pipeline.
Clinical Trial Manager/Senior Clinical Trial Manager Oruka Therapeutics IncClinical Trial Manager/Senior Clinical Trial ManagerWaltham, MA$146,000–$161,000 / yearOruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Key Responsibilities: Clinical Trial Management: Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.
Pharmaceutical Territory Sales Specialist Inizio EngagePharmaceutical Territory Sales SpecialistBoston, MassachusettsOur passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. As part of our commitment to a fair and equitable hiring process, candidates are expected to complete all interview activities without the use of artificial intelligence tools or external assistance unless such assistance is authorized in advance by Inizio Engage or otherwise required in accordance with applicable law.
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.
Senior Medical Director, Psychiatry Rapport Therapeutics IncSenior Medical Director, PsychiatryBoston, MA$285,000–$350,000 / yearProven clinical development strategist with hands-on experience of designing, implementing, and conducting clinical trials in neurology, Phase 2a - Phase 3. Working knowledge of psychiatry indications is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports. Working closely with functional partners (Clinical Operations, Data Management, Biostatistics, Regulatory, Medical Affairs) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocols.
Director, Global Quality Control Scholar RockDirector, Global Quality ControlCambridge, MAThis role provides technical and operational leadership for commercial release and stability testing, specification lifecycle management, analytical method lifecycle activities, external laboratory oversight, and QC support for post-approval changes, regulatory commitments, and global market supply. Lead and manage key elements of Scholar Rock’s commercial QC function across a fully outsourced model, with direct oversight of external QC laboratories, CMOs, and contract partners supporting commercial drug substance, drug product, raw material, in-process, release, and stability testing.
Associate Director Drug Product Technical Operations Vor BioPharma IncAssociate Director Drug Product Technical OperationsBoston, MA$170,000–$195,000 / yearDrug Product and Combination Product Integration: Partner closely with the Combination Product Development Lead to ensure alignment between drug product characteristics, primary container systems, prefilled syringes, needle safety devices, autoinjectors, fill-finish processes, device performance, and product presentation requirements. This role will have end-to-end accountability for drug product manufacturing from late-stage development through commercialization, including manufacturing strategy, technology transfer, aseptic fill-finish, process validation, lifecycle management, commercial readiness, and Drug Product Module 3 content.
Clinical Development Medical Director-Nephrology Vertex Pharmaceuticals IncClinical Development Medical Director-NephrologyBoston, MA$204,000–$306,000 / yearParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. Provides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports.