NewEngineering Manager: Verification Testing for Medical Devices MedtronicEngineering Manager: Verification Testing for Medical DevicesBoxborough, Massachusettswhich includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
NewExecutive Director, Clinical Pharmacology and Pharmacometrics Sumitomo Pharma America Holdings Inc (Inactive)Executive Director, Clinical Pharmacology and PharmacometricsMarlborough, MA$270,300–$337,900 / yearThey will influence oncology development strategy across the portfolio and provide senior Clinical Pharmacology expertise for business development, licensing, partnerships, and due diligence, including evaluation of external assets, PK/PD and exposure-response data, dose and regimen strategies, combinations, and development risks. The role requires deep expertise in clinical pharmacology, pharmacometrics, quantitative drug development, and oncology, combined with strong organizational leadership, scientific judgment, and cross-functional collaboration.
Product Quality Assurance Engineer ZOLL MedicalProduct Quality Assurance EngineerChelmsford, MassachusettsRemote$82,400–$90,000 / yearThis role partners with Engineering, Manufacturing, Regulatory, and Post-Market teams to support investigations, analyze product performance, and contribute to activities that improve product reliability, patient safety, and compliance for medical devices. Job Summary The Product Quality Assurance Engineer supports product quality throughout the product lifecycle, with a focus on complaint investigations, risk management support, and product quality monitoring.
Director/Senior Director, Nonclinical Safety Toxicology Nimbus Therapeutics LLCDirector/Senior Director, Nonclinical Safety ToxicologyBoston, MA$225,000–$285,000 / yearManage nonclinical safety studies conducted by CROs with efficient governance including contract execution, authorization of study amendments, schedule and budget variance management, progress reporting to stakeholders, review of data and draft study reports, completion of contract milestones, study close-out and alignment of nonclinical safety evaluations with drug development efforts and priorities. Collaborate with CMC, Program & Portfolio Management, Clinical, Medical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND/CTA filing, and clinical development of new small molecule drug entities.
Senior Director, Quality Assurance, Commercial Xenon PharmaceuticalsSenior Director, Quality Assurance, CommercialNeedham, MassachusettsOur Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. We are seeking a Senior Director, Quality Assurance, Commercial as an integral leader within the Quality GMP team as well as a key member of highly collaborative R&D Operations group comprised of Program Management, CMC, Regulatory Affairs, Supply Chain and Quality functions.
Senior Clinical Scientist WhoopSenior Clinical ScientistBoston, MassachusettsOperating with minimal oversight, you will translate clinical and product questions into rigorous research approaches, generate and interpret evidence from clinical, wearable, and real-world data, and communicate findings in a way that informs product decisions, regulatory strategy, and clinical evidence generation. Independently author and review clinical study reports, protocols, statistical analysis plans, literature reviews, clinical evidence summaries, regulatory submission sections, manuscripts, abstracts, and internal scientific memos.
CMC Dossier Leader SanofiCMC Dossier LeaderCambridge, MA$148.50–$214.50 / hourThe CMC Dossier Sciences department within Sanofi R&D Global CMC Development organization has critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company's product development through clinical phases to market authorization. Join our CMC dossier Sciences team as CMC dossier leader and you'll contribute to the CMC development of Sanofi components and products, while enjoying lots of opportunities to broaden your experience and hone your skills.
CMC dossier leader SanofiCMC dossier leaderFramingham, MA$148.50–$214.50 / hourThe CMC Dossier Sciences department within Sanofi R&D Global CMC Development organization has critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company's product development through clinical phases to market authorization. Core Competencies: Strategic planning, time management, and communication, digital transformation leadership within CMC community, innovative problem-solving for CMC dossier challenges, change management and process optimization.
Staff Clinical Scientist WhoopStaff Clinical ScientistBoston, MA$170,000–$220,000 / yearRaise the scientific bar across the Clinical organization by mentoring Clinical Scientists and Senior Clinical Scientists, identifying scientific risks and opportunities, and contributing to WHOOP's longer-term clinical research and evidence-generation roadmap. This role is ideal for an experienced clinical scientist who combines deep expertise in study design, statistics, clinical evidence generation, and scientific communication with the ability to influence strategy across a highly cross-functional organization.
Senior Director, Biostatistics Bicycle Therapeutics PlcSenior Director, BiostatisticsLexington, MA$235,000–$295,000 / yearThe company is evaluating nuzafatide pevedotin (formerly BT5528), a Bicycle Drug Conjugate (BDC) targeting EphA2, a historically undruggable target; a pipeline of Bicycle Radioconjugates (BRCs) and imaging agents; zelenectide pevedotin (formerly BT8009), a BDC targeting Nectin-4, a well-validated tumor antigen; and, through various partnerships, the use of Bicycle technology to develop therapies to treat diseases in a range of therapeutic areas. At Bicycle, we benefit from a hybrid style working arrangement, allowing our employees where possible the opportunity to collaborate and engage with their coworkers in person while also benefiting from the flexibility of home remote working.
Executive Medical Director- Nephrology Vertex PharmaceuticalsExecutive Medical Director- NephrologyBoston, Massachusetts$320,000–$480,000 / yearThe Executive Medical Director, Clinical Development will provide high-level input on clinical development strategies to povetacicept renal programs, in conjunction with other relevant functional area leaders in Medical Affairs, Regulatory, Global Patient Safety, Clinical Operations, Exploratory Development, Commercial, Pharmaceutical Development, Research, Business Development, and Marketing. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Sr Manager, Fp&A - Global Operations (Boston Based) Haemonetics Corp.Sr Manager, Fp&A - Global Operations (Boston Based)Boston, MA$124,300–$211,700 / yearThe successful candidate will bring a passion and proven capabilities in: (1) designing and managing financial reporting, planning and analytics processes, (2) developing trusted business partner relationships ideally within a global manufacturing & supply chain function, and (3) partnering with technical teams to translate complex financial reporting and analytics requirements into technology requirements for efficient solution delivery. Reporting to the VP, Global Operations Finance, the Senior Manager will act as the leader and central point of contact for all core financial planning and analysis processes and communications supporting the COO-lead organizations (Global Manufacturing & Supply Chain, R&D, Quality and Regulatory Affairs).
Principal Software Applications Engineer Onsite in Burlington MA Glaukos CorpPrincipal Software Applications Engineer Onsite in Burlington MABurlington, MAReporting to the Director of Software Development, the Principal Software Development Engineer works side-by-side with software, electrical, mechanical engineers, and scientists to design and create software code within our products to achieve design goals. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Sr Manager, FP&A - Global Operations (Boston based) Haemonetics CorpSr Manager, FP&A - Global Operations (Boston based)Boston, MA$124,300–$211,700 / yearThe successful candidate will bring a passion and proven capabilities in: (1) designing and managing financial reporting, planning and analytics processes, (2) developing trusted business partner relationships ideally within a global manufacturing & supply chain function, and (3) partnering with technical teams to translate complex financial reporting and analytics requirements into technology requirements for efficient solution delivery. Reporting to the VP, Global Operations Finance, the Senior Manager will act as the leader and central point of contact for all core financial planning and analysis processes and communications supporting the COO-lead organizations (Global Manufacturing & Supply Chain, R&D, Quality and Regulatory Affairs).
Partner Engineer II, GSI, Google Cloud Google LLCPartner Engineer II, GSI, Google CloudCambridge, MAOwn the technical relationship with partners, empowering them to drive a successful pilot or proof of concept; support partners drive toward customer acceptance of the technical proposal, leading to an agreement; and work with partners during the migration phase to assure they have all the tools necessary to deliver a successful deployment. Once educational institutions, government agencies, and other businesses sign on to use Google Cloud products, you come in to facilitate making their work more productive, mobile, and collaborative.
Director or Senior Director, CMC Program Management Kymera Therapeutics IncDirector or Senior Director, CMC Program ManagementWatertown, MA$195,000–$330,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. How you'll make an impact: Drive end-to-end CMC program management for mid to late-stage programs, including timeline development, critical path identification, risk assessment, and execution tracking.
Senior Director, Patient Team Operations & Chief Of Staff To The Chief Patient Officer Stoke Therapeutics, Inc.Senior Director, Patient Team Operations & Chief Of Staff To The Chief Patient OfficerBedford, MA$269,000–$299,000 / yearPosition Summary: The Senior Director, Patient Team Operations & Chief of Staff to the Chief Patient Officer (CPO) serves as a strategic and operational leader supporting the execution of enterprise patient strategy across Commercial, Medical Affairs and Manufacturing functions. The Senior Director will serve as a key liaison between the Patient Organization and cross-functional program teams to ensure integrated planning, decision-making, and operational follow-through across development and commercialization activities.
Head of Benefit-Risk and Pharmacoepidemiology SanofiHead of Benefit-Risk and PharmacoepidemiologyCambridge, MA$293,250–$423,583.33 / yearThe mission of Epidemiology and Benefit-Risk (Epi & BR) Head is to (1) lead the generation of Epi and BR data required by Regulatory authorities and for Sanofi internal teams to characterize product risks and inform decision at BRAC and the benefit/risk for product in development and marketed products across all GBUs, (2) lead innovations in new methods and tools for safety signal and risk assessment using RWE data, and (3) shape the external policy and guidance in these fields. The Benefit-Risk and Pharmacoepidemiology (BR & PVEpi) team is an international group of experts in process, method and technology experts dedicated to supporting Patient Safety and Pharmacovigilance supporting safety signal management and monitoring of product benefit-risk throughout the product lifecycle.
Head Of Benefit-Risk And Pharmacoepidemiology SanofiHead Of Benefit-Risk And PharmacoepidemiologyCambridge, MA$293,250–$423,583.33 / yearThe mission of Epidemiology and Benefit-Risk (Epi & BR) Head is to (1) lead the generation of Epi and BR data required by Regulatory authorities and for Sanofi internal teams to characterize product risks and inform decision at BRAC and the benefit/risk for product in development and marketed products across all GBUs, (2) lead innovations in new methods and tools for safety signal and risk assessment using RWE data, and (3) shape the external policy and guidance in these fields. The Benefit-Risk and Pharmacoepidemiology (BR & PVEpi) team is an international group of experts in process, method and technology experts dedicated to supporting Patient Safety and Pharmacovigilance supporting safety signal management and monitoring of product benefit-risk throughout the product lifecycle.
Product Manager, On Market Hemostasis Systems WerfenProduct Manager, On Market Hemostasis SystemsBedford, Massachusetts$125,000–$150,000 / yearFull timeWorking closely with cross-functional teams including R&D, Clinical Affairs, Regulatory Affairs, Quality, Operations, Technical Services, and Marketing Management, the Product Manager will support market adoption and optimize portfolio performance throughout the product lifecycle. The ideal candidate brings expertise in the management of capital equipment, especially in the diagnostic or life sciences sector, coupled with a proven track record in regional product marketing, commercial strategy, and sales.