Senior Clinical Trial Manager Eight SleepSenior Clinical Trial ManagerBoston, MassachusettsThis is a hands-on, operationally intense position for someone who knows how to stand up a study from scratch, manage third-party clinical sites, write IRB and informed consent documents, oversee data management, and drive studies to completion on time and on budget. Collaborate cross-functionally with regulatory affairs, product, engineering, data science, and legal teams to ensure clinical strategies align with product development and submission timelines.
Head Of AI Clinical Excellence PfizerHead Of AI Clinical ExcellenceCambridge, MA$176,600–$294,300 / yearYou will partner closely with the Oncology Clinical Development, Clinical Operations, Biostatistics, Data Science, Medical Affairs, Regulatory Affairs, and Digital organizations to identify, develop, and scale AI-driven capabilities that improve trial design, data review, study execution, operational efficiency, decision-making, and regulatory readiness. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Medical Writer Integrated Resources, IncMedical WriterMassachusettsContractorPosition Title: Medical Writing Specialist Division: Strategic Medical Affairs Reports To: Medical Safety Project Manager Job Function Summary The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
Associate Director, Global Submission Management Vertex Pharmaceuticals, IncAssociate Director, Global Submission ManagementBoston, MA$163,200–$244,800 / yearThis role partners closely with Major Submission Leads, Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion functions to support coordinated submission planning, execution consistency, and steady‑state portfolio throughput. General Summary: The Associate Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs.
Paralegal and Legal & Compliance Operations Manager Genetix BiotherapeuticsParalegal and Legal & Compliance Operations ManagerSomerville, Massachusetts$120,000–$155,000 / yearDemonstrated experience in the pharmaceutical, biotechnology, or medical device industry, with working knowledge of the federal Anti-Kickback Statute, the False Claims Act, the Physician Payments Sunshine Act, the PhRMA Code, and Office of Inspector General compliance program guidance. Serve as day-to-day administrator of the contract lifecycle management system, including intake triage, routing, template selection, version control, execution through the electronic signature platform, and post-execution filing and obligation tracking.
Senior Medical Science Liaison - Pain (Georgia) Vertex PharmaceuticalsSenior Medical Science Liaison - Pain (Georgia)Boston, MassachusettsThe Sr MSL serves as a scientific liaison to the medical/academic community and is responsible for establishing and maintaining relationships with (Allied) Health Care Providers/Professionals (HCPs) and other key stakeholders involved in healthcare decision making to ensure the appropriate dissemination of clinical, scientific, and health economic data with respect to pain and Vertex’s compounds in a timely, ethical, and stakeholder-focused manner. Key Duties & Responsibilities . 1. Develops and fosters effective and trusting relationships with Thought Leaders and identifies and engages other appropriate (allied) HCPs and other stakeholders involved in clinical practice decision making with regards to managing conditions associated with pain, resulting in scientific engagement with a large network of stakeholders involved in affecting care of patients experiencing pain.
NewSenior Manager, Marketing Operations Deciphera Pharmaceuticals IncSenior Manager, Marketing OperationsWaltham, MA$130,000–$179,000 / yearROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera's platform in clinical studies, QINLOCK (ripretinib) is Deciphera's switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Director, Analytical Development and Validation, Tech Ops (Biologics) Oruka TherapeuticsDirector, Analytical Development and Validation, Tech Ops (Biologics)Waltham, MassachusettsThe ideal candidate is a hands-on leader with deep expertise in analytical method validation, device functional testing, regulatory expectations for late-stage biologics, and the ability to guide teams through complex technical and compliance-driven milestones. This role will lead method validation and comparability efforts in support of BLA/MAA submissions, process changes, and commercial readiness, while partnering closely with CMC, Quality, Regulatory Affairs, and external partners.
Director of Hardware Product Compliance WhoopDirector of Hardware Product ComplianceBoston, 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. Working closely with product, engineering, operations, and executive leadership, you’ll embed compliance into the product lifecycle from concept through commercialization – balancing innovation, speed, and regulatory rigor in a dynamic, growth-oriented environment.
Medical Communication Associate Integrated Resources, IncMedical Communication AssociateLexington, MassachusettsContractorMedical Information Manager-This position is for Global Medical Information (North America Region) Develop and communicate appropriate, quality and timely responses to requests for medical information in NA Develop and implement medical information support materials Report potential adverse events and product issues to appropriate teams Support management of medical information providers Responsibilities 70% of Time Job Function and Description Develop and communicate appropriate, quality and timely responses to Medical Information requests • Internally or in collaboration with Medical Communications and Global Medical Teams, develop and communicate timely, accurate responses to unique and escalated inquires • Develop medical information materials (e.g. Education and Experience Requirements A medical or scientific degree is required (PharmD, MD, or PhD preferred) 5-7 years of related work experience preferred 2 years of experience in the bio pharmaceutical industry, preferably within a matrix structure.
Manager, Medical Information Sequel Med TechManager, Medical InformationManchester, New HampshireEnvironmental/Safety/Physical Work Conditions Ensures environmental consciousness and safe practices are exhibited in decisions Use of computer and telephone equipment and other related office accessories/devices to complete assignments May work extended hours during peak business cycles Physical requirements such as lifting specific weights Some travelling is expected Data Interpretation & Statistical Literacy: Ability to interpret clinical and real-world data—including study endpoints, confidence intervals, and effect sizes—and communicate findings accurately to scientific and lay audiences.
Patient Safety Medical Director Vertex PharmaceuticalsPatient Safety Medical DirectorBoston, Massachusetts$276,000–$414,000 / yearDirectly and/or via oversight of direct reports, the role will lead pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The Senior Medical Director, Patient Safety, Disease Area Safety Head (DASH) will lead all safety and benefit-risk related activities for products within the role's Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization.
Director of Quality Systems ElucidDirector of Quality SystemsBoston, MARemoteFull timeDeep hands-on experience guiding software development lifecycle activities in an agile environment with monthly releases (testing strategy, design transfer, release processes, etc.), working with Product and Engineering teams to maintain compliance and champion a culture of quality. We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs.
Director, Medical Information Amylyx PharmaceuticalsDirector, Medical InformationCambridge, MARemote$211,000–$237,000 / yearPartner cross-functionally with Medical Affairs, Field Medical, Scientific Communications, Clinical Development, Pharmacovigilance/Drug Safety, Quality, Commercial, Market Access, Patient Support, and other teams to support compliant scientific exchange, launch readiness, operational excellence, and appropriate escalation of inquiries, adverse events, and product quality complaints. The role will partner closely with Medical Affairs, Field Medical, Scientific Communications, Clinical Development, Pharmacovigilance/Drug Safety, Quality, Commercial, Market Access, Patient Support, and other functions to support compliant scientific exchange and launch readiness.
Senior Clinical Research Director SanofiSenior Clinical Research DirectorCambridge, MA$236,250–$393,750 / yearCollaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. Collaborate with other CRDs within the project, ensure leadership, buildsconsensus, coordinate action plans with stakeholders to resolve project-related study issues, anticipate potential issues (sharing lessons learned) across the project or study teams.
Clinical Development Medical Director - Cardiovascular GSK plcClinical Development Medical Director - CardiovascularWaltham, MA$222,750–$371,250 / yearIn addition to providing clinical and scientific leadership to clinical and translational studies or programs for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion, and innovative clinical development opportunities. Serve as the primary Clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators and with the relevant internal review boards (e.g., Technical Review or Governance) and/or Protocol Review Board.
Medical Director Clinical Development- Respiratory GSK plcMedical Director Clinical Development- RespiratoryWaltham, MA$222,750–$371,250 / yearIn addition to providing clinical and scientific leadership to clinical and translational studies or programs for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion, and innovative clinical development opportunities. Serve as the primary Clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators and with the relevant internal review boards (e.g., Technical Review or Governance) and/or Protocol Review Board.
Director Of Financial Aid Benjamin Franklin Cummings Institute of TechnologyDirector Of Financial AidBoston, MA$85,000–$105,000 / yearThe Director also provides strategic oversight of the College's outsourced financial aid partner (FA Solutions), establishing performance expectations, monitoring service delivery, ensuring contractual compliance, and fostering a collaborative partnership that supports institutional goals and an exceptional student experience. As a key member of the Enrollment Services leadership team, the Director collaborates closely with Admissions, Student Accounts, the Registrar, Student Affairs, Finance, Information Technology, Academic Affairs, and external agencies to remove financial barriers and advance the College's enrollment and student success goals.
Senior Engineer/Manager, Process Validation Stoke Therapeutics, Inc.Senior Engineer/Manager, Process ValidationBedford, MA$140,000–$161,000 / yearCollaborate with internal and external partners to develop and define key product lifecycle documentation, including quality attribute and process risk assessments (FMEAs), process control strategy documents, continued process verification control plans, etc. Using Stoke's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels.
Scientist, Analytical Sciences and Technology ModernaTXScientist, Analytical Sciences and TechnologyNorwood, 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 Candidate will serve as a key technical resource across the analytical network, collaborating with Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing Sciences, and Contract Manufacturing Organizations (CMOs) to ensure robust analytical performance, compliance, and inspection readiness.