Director/Senior Director, Patient-Centered Outcomes LumanityDirector/Senior Director, Patient-Centered OutcomesBoston, MassachusettsRemoteDemonstrated ability to develop endpoint and regulatory strategy for assigned projects by applying regulatory guidance and precedent to evidence plans (e.g., study design), regulatory interaction support (e.g., correspondence, meeting materials), and regulatory documentation (e.g., briefing books, dossiers), escalating complex or novel issues as needed. Quality & Scientific Integrity: Conducts senior-level review of analyses, data interpretations, and client deliverables to ensure they meet scientific integrity, accuracy, and alignment to scope and intended use, and ensures projects are conducted in compliance with the PCO Quality Management System and applicable SOPs.
Senior Director, Manufacturing Engineering TransMedics Group, Inc.Senior Director, Manufacturing EngineeringAndover, MA$220,600–$314,050 / yearDirector of Manufacturing Engineering is a pivotal leadership role within TransMedics Supply Chain organization, leading Advanced Operations (New Product & Technology Introduction), Sustaining Engineering, Manufacturing (Process) Engineering, and Technical Field Service. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.
Director of Product, Life Sciences (Chemistry) Lila SciencesDirector of Product, Life Sciences (Chemistry)Cambridge, Massachusetts$184,000–$256,000 / year7+ years of product leadership (PM, Group PM, Product Lead) building and launching complex technical products: therapeutic platforms, scientific software or hardware, simulation and modeling platforms, data products, or ML-enabled systems. You will be deeply customer-facing, serving as a trusted technical and product voice with prospects and partners, shaping proposals, driving commercial conversations, and closing deals that bring Lila's therapeutics platform to market.
Associate Director, Engineering Projects Novo NordiskAssociate Director, Engineering ProjectsLexington, MA$175,000–$225,000 / yearThis role has direct reporting line to the Head of US R&D Operations and a dotted reporting line to Head of R&D Investments (CAPEX) and will have collaborative and cross-functional relationships/responsibilities with onsite Facilities and Lab Operations, Global R&D IPG, North America and NN Global teams. As a member of the US R&D Facilities Leadership Team, the Associate Director is accountable for capital strategy, operations engineering governance and project oversight ensuring projects progress from concept through approval, execution and close-out while meeting business, regulatory, quality and operational requirements.
Director, Supplier Quality, Inspection & Audit Centessa Pharmaceuticals, LLCDirector, Supplier Quality, Inspection & AuditBoston, MA$150,000–$210,000 / yearThe Director, Supplier Quality, Inspection & Audit role will provide strategic leadership and tactical support for supplier quality management, GxP supplier audit programs, inspection readiness, and supplier quality oversight across the portfolio. Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders.
Director, HEOR – Orexin Franchise Centessa Pharmaceuticals, LLCDirector, HEOR – Orexin FranchiseBoston, MA$180,000–$260,000 / yearReporting to the Executive Director, HEOR, the, you will partner extensively with Medical Affairs, Clinical Development, Market Access, Commercial, Legal, Regulatory, and external research partners to translate strategic objectives into actionable, well-governed research plans throughout the product lifecycle — from early pipeline evidence generation and launch readiness through post-launch value demonstration. Lead and manage HEOR studies, including retrospective and prospective observational studies, database analyses (claims, EHR, registries), and innovative designs such as external control arms to contextualize single-arm trial data.
Director, External Quality Control & Stability Centessa Pharmaceuticals, LLCDirector, External Quality Control & StabilityBoston, MA$150,000–$210,000 / yearCentessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. The Director, External Quality Control & Stability will provide leadership and oversight for analytical testing, stability programs, specification management, and quality control activities supporting clinical and commercial development.
Associate Director, Clinical Quality Assurance Centessa Pharmaceuticals, LLCAssociate Director, Clinical Quality AssuranceBoston, MA$140,000–$180,000 / yearCentessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.
Associate Director, Regulatory Project Management Centessa Pharmaceuticals, LLCAssociate Director, Regulatory Project ManagementBoston, MA$140,000–$200,000 / yearServing as the central hub for regulatory projects, the Regulatory Project Manager (RPM) is accountable for regulatory project timelines, ensuring effective planning, tracking, execution, and delivery of submissions to health authorities worldwide. Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders.
Senior Director, Regulatory CMC Centessa Pharmaceuticals, LLCSenior Director, Regulatory CMCBoston, MA$175,000–$260,000 / yearCentessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Reporting to the Executive Director, Regulatory CMC, you will lead Regulatory CMC initiatives, develop and execute global CMC regulatory strategies, partner with internal and external stakeholders, and oversee CMC regulatory submissions across our portfolio.
Associate Director, Specialty Pharmacy Operations Madrigal Pharmaceuticals IncAssociate Director, Specialty Pharmacy OperationsWaltham, MARemote$180,000–$221,000 / yearMadrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Director Business Development Haverhill Behavioral HealthDirector Business DevelopmentHaverhill, Massachusetts$70,000–$90,000 / yearWork collaboratively with all levels of facility and division sales leadership to support the organizations mission and revenue goals by selling of service line attributes, processes and outcomes to consumer, physician and market facility groups/individuals. Work closely with hospital discharge planners, social workers, case managers, physicians, management, inpatient unit and education staff to generate referral sources.
Director, Contracts Counsel MBX BiosciencesDirector, Contracts CounselBurlington, MAAdditional more detailed summary of responsibilities include: Draft, review, and negotiate a wide variety of agreements, including but not limited to: clinical trial agreements (CTAs), master service agreements (MSAs) and statements of work with CROs and clinical sites, confidentiality/non-disclosure agreements, material transfer agreements (MTAs), consulting and advisory agreements, manufacturing and supply agreements, quality agreements, licensing and collaboration agreements, and vendor/procurement contracts. Our pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism, currently preparing for Phase 3 development, and a growing obesity portfolio that includes MBX 4291 in Phase 1 development, MBX 5765, a next-generation amycretin prodrug designed for once-monthly-dosing, as well as MBX 6180, a GLP/GIP/GCGR triple agonist prodrug for once monthly dosing; all of which optimize our PEP platform.
NewDirector, IT Business Partner Commercial ReplimuneDirector, IT Business Partner CommercialWoburn, Massachusetts$208,000–$270,000 / yearThe RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. · Oversee the support and integration of various marketing tools and platforms with the CRM (Salesforce/Veeva) system to enhance marketing automation and customer interaction and manage third party support providers.
Senior Director, Biomarker Development, Strategy and Operations Zenas BioPharma (USA) LLCSenior Director, Biomarker Development, Strategy and OperationsWaltham, MA$227,000–$283,785 / yearZenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases.
Senior Director, Clinical Translational Scientist Kiniksa Pharmaceuticals CorpSenior Director, Clinical Translational ScientistLexington, MA$279,450–$302,220 / yearKiniksa is seeking an accomplished and strategic Senior Director, Clinical Translational Scientist reporting to GVP, Research & Non-Clinical Development to play a critical leadership role in advancing clinical-stage development programs from early clinical development through proof-of-concept and registrational studies. This individual will serve as a key scientific leader across multidisciplinary teams, integrating insights from Research, Clinical Development, Clinical Pharmacology, Bioanalysis, Biostatistics, Regulatory Affairs, and Medical Affairs to maximize the probability of technical and regulatory success across the portfolio.
Senior Director, Healthcare Compliance Kiniksa Pharmaceuticals CorpSenior Director, Healthcare ComplianceLexington, MA$250,000–$280,000 / yearProvide clear, actionable guidance on complex topics, including: Engagements with Healthcare Professionals (HCPs), sponsorships, grants, and charitable contributions, patient support programs, patient advocacy group interactions, market access and emerging commercialization models. We are seeking a strategic, enterprise-minded Senior Director, Healthcare Compliance reporting to VP, Head of Compliance to serve as the primary Compliance & Ethics business partner to our Commercial organization and key external-facing functions (Medical Affairs, Patient Services, and Patient Advocacy).
Director, Global Compliance Zenas BioPharma (USA) LLCDirector, Global ComplianceWaltham, MA$180,000–$226,051 / yearZenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases.
Senior Manager / Associate Director, HCP Marketing (US) Scholar Rock Holding CorpSenior Manager / Associate Director, HCP Marketing (US)Cambridge, MA$155,000–$225,000 / yearScholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases.
Associate Director, R&D Quality Engineering Boston Dynamics IncAssociate Director, R&D Quality EngineeringWaltham, MA$155,000–$195,000 / yearThe Associate Director, R&D Quality Engineering is a senior leadership role responsible for the quality engineering function across Prototype Operations - spanning prototype builds, low-volume production, supplier quality, and the failure investigation discipline that turns hardware problems into design and process improvements. Define and execute a quality strategy fit for prototype-to-production reality: right-sized controls that scale with build rate and design maturity, applied deliberately rather than inherited from mass-production dogma.