NewAssociate Director, Labeling and Disclosures Sarepta Therapeutics IncAssociate Director, Labeling and DisclosuresCambridge, MA$160,800–$201,000 / yearPrimary Responsibilities Include: Leads cross-functional labeling teams to develop and maintain US Full Prescribing Information and associated local labeling documents, Company Core Data Sheets (CCDS), and Target Product Labeling (TPL) for marketed and development products. The Associate Director is responsible for effectively partnering and engaging with internal (e.g., cross-functional study teams, senior management) and external key stakeholders (e.g., vendors, business partners) to ensure business needs and regulatory requirements are met, prioritized, and communicated.
Director Purification Development Emerging Modalities Alnylam Pharmaceuticals IncDirector Purification Development Emerging ModalitiesMA$191,700–$259,300 / yearOverview: The Director, Purification Development, Emerging Modalities will provide technical leadership for purification development across novel modalities, with primary responsibility for antibody purification and close partnership with internal teams supporting antibody-oligonucleotide conjugate (AOC) programs. Provide technical leadership on purification challenges associated with complex and conjugated molecules, including removal of residual species, aggregates, unconjugated components, process-related impurities, and other modality-specific quality risks.
Sr. Director, Biostatistics Atavistik BioSr. Director, BiostatisticsCambridge, MAAtavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, Lux Capital, Regeneron Ventures, and RA Capital Management. Oversee and lead the vendor/CRO biostatistics and programming teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks.
Medical Director - PACE NeighborHealth CorporationMedical Director - PACERevere, MAFull timePartner with NeighborHealth’s CMO and senior leadership to align clinical strategies, ensuring the PACE program’s localized care model meets broader enterprise objectives. Whether you're a nurse or physician providing direct care, a manager leading dedicated teams, or part of the essential support staff who keep our operations running smoothly — every role at NeighborHealth is vital.
Senior Manager/Associate Director, Enterprise Integration & Data Engineering Xenon PharmaceuticalsSenior Manager/Associate Director, Enterprise Integration & Data EngineeringNeedham, MassachusettsA bachelor’s degree or advanced degree in Information Systems, Computer Science, Data Engineering, Engineering, Business Administration, with a minimum of 7-10 year’s prior experience with enterprise integration, data engineering, middleware, cloud data platform, analytics platform, or enterprise applications experience; Experience in a corporate IT environment is preferred. Manage the implementation and maturation of Xenon’s enterprise integration and data engineering capabilities, including middleware/iPaaS, API-based integration, event/message-based integration, file-based ingestion, and ELT/data pipeline patterns.
Medical Laboratory Director CareDxMedical Laboratory DirectorWaltham, Massachusetts$142,000–$185,000 / yearThrough our innovative portfolio of molecular diagnostics, digital health solutions, AI-powered data and analytics, and patient support services, we partner with healthcare providers, patients, and biopharma organizations to help inform clinical decision-making and improve patient outcomes. This role will partner closely with Laboratory Operations and cross-functional stakeholders to support laboratory performance, quality assurance, regulatory compliance, staffing, budgeting, technology evaluation, and continuous process improvement.
Associate Director Inspection Management (Gcp) Regeneron PharmaceuticalsAssociate Director Inspection Management (Gcp)Uxbridge, MAThe GDQIM IML will engage with key stakeholders, build strategic partnerships working and liaising with Clinical Study teams, relevant functions and other GDQ functions to support teams with inspection preparation activities on all Regeneron-sponsored clinical trials. Serving as the back room lead/co-lead or front room co-lead, responsible for explaining, managing,and ensuring the execution of all activities, including managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection conducted worldwide.
Associate Director, Global Scientific Communications Bicara TherapeuticsAssociate Director, Global Scientific CommunicationsBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Associate Director, Financial Planning & Analysis (Development Finance Business Partner) Bicara TherapeuticsAssociate Director, Financial Planning & Analysis (Development Finance Business Partner)Boston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Sr. Director, Regulatory Affairs Third Rock VenturesSr. Director, Regulatory AffairsCambridge, MA$245,000–$300,000 / yearThis individual will serve as a key cross-functional leader and regulatory expert, partnering closely with Program Leadership & Management, Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, CMC, Nonclinical, Quality, and Executive Leadership to advance innovative therapeutics through development and key regulatory milestones. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity.
NewSenior Director, Program & Portfolio Management Vera Therapeutics Inc.Senior Director, Program & Portfolio ManagementBoston, MAThis person will also lead the Research and Development Governance and will partner closely with the Global Program Team Lead (GPTL) and the Global Program Team (GPT) Program Manager to ensure strategic direction set by the GPT translates into clear, well-coordinated execution across Program Teams and Governance Forums. Serve as the principal execution partner to the Global Program Team Lead (GPTL) and GPT Program Manager, translating GPT-level strategy into coordinated execution plans and ensuring program risk and status are communicated clearly across governance layers.
Sr. Director, Head, Quantitative Systems Pharmacology Moderna IncSr. Director, Head, Quantitative Systems PharmacologyCambridge, MA$196,700–$353,400 / yearIn addition to leading QSP strategy and capabilities, this role is expected to serve directly as the CQP representative within key program teams, driving model-informed drug development strategy and enabling portfolio decisions in close partnership with cross-functional leaders. This leader will define and execute the vision for how mechanistic modeling, systems biology, and model-informed drug development (MIDD) approaches are applied across discovery, preclinical, and clinical stages to accelerate early development decisions, strengthen translational understanding, and optimize dose, schedule and patient selection strategies.
Director, Site Performance & Strategy - Cardiology Iterative Scopes IncDirector, Site Performance & Strategy - CardiologyCambridge, MA$170,000–$215,000 / yearIf you''ve spent years building frameworks for other people''s businesses in consulting, or running ops at a startup where you had to build the plane while flying it, this is where that skill set gets applied to a mission that matters: accelerating clinical trials that bring new treatments to patients faster. Serving as the operational owner of our centralized site solutions-including pre-screening, regulatory support, and eSource-you will partner cross-functionally to optimize workflows, scale capabilities, and improve site and sponsor outcomes.
Director, Psychometrics & Patient-Reported Outcomes (PRO) Strategy Ipsen SADirector, Psychometrics & Patient-Reported Outcomes (PRO) StrategyCambridge, MA$177,000–$259,600 / yearPartner effectively across the enterprise to support the identified psychometric needs across Oncology, Rare Disease and Neuroscience and play a central role in designing PRO strategies that address key evidence needs and gaps; Oversee and drive methodologic strategy for patient-reported/patient-centered outcome study strategies & designs, including studies where patient-reported outcome (PRO) instruments are to be developed and/or validated and/or evaluations need to be conducted around mapping of clinically meaningful changes in patient-reported outcome measurements; Collaborate with cross-functional teams to ensure well designed patient-centered outcome endpoints are included in clinical development studies and patient-centric endpoints are available for HTA and regulatory submissions; Partner with Clinical Development teams to provide support for study design and planning activities; Support, as relevant, design of fit-for-purpose data generation and analytic methodologies that advance research goals across different LCM stages; Develop and review study protocols and statistical analyses plans in collaboration with Biometrics, Medical and other internal stakeholders; Stay informed and involved on the latest HTA and Regulatory and methodological advances that expand and enhance the utility of PROs. Fully involve Ipsen stakeholders (GMA TAs, R&D, HEOR, Regulatory, Clin Ops, GMPC, and affiliates) in the design and implementation of studies around PROs, from design to communication; Ensure Ipsen can provide comprehensive patient focused data & analytics in the disease areas we serve; Drive cross-functional and global dialogue to enable early strategic alignment of PRO data across global and local teams, in partnership with the cross-functional partners across product life cycles, to ensure company is working with single source of information; Establish end-to-end best practice for information sharing regarding PROs used across assets; Conduct educational sessions around key topics of interest and relevance to internal stakeholders, with a goal to build educational modules.
Senior Director, AIRx Discovery Biology Lead Takeda Pharmaceutical Co LtdSenior Director, AIRx Discovery Biology LeadBoston, MA$212,000–$333,190 / yearThe AIRx Discovery Biology Lead combines deep scientific expertise with the agility to thrive in an externalized, AI-powered operating model - leveraging biological depth and pragmatism to direct and integrate biology at speed, while role modeling new ways of working in Discovery Automation & Robotics (DAR) group. Responsibilities include directing CRO partners with precision and accountability to generate high-quality, interpretable data that feeds into AI-powered DMTA cycles, and connecting experimental biology to translational strategy and clinical outcomes.
Lead Medical Director, Product Development, Hematology Genentech IncLead Medical Director, Product Development, HematologyBoston, MA$213,000–$396,000 / yearYou have a solid understanding of Phase II - III drug development (e.g trials across different stages of development, or formal education/qualifications in pharmaceutical medicine or drug development); have made significant contributions to an organization's drug development (whether at Roche or another organization); have identified and created clinical development strategies that have led to label-enabling outcomes. You will be responsible to ensure strategic and operational alignment of the CDP with the relevant CD strategy, strategic and annual LCP; you will work with other CST members and relevant sub-teams to develop CDP components (e.g., analytics/data strategy, KOL development, publications strategy, etc.).
clinic director physical therapist IVYREHAB Network Incclinic director physical therapistNorth Smithfield, RIWe encourage our clinicians to pursue specialties they are passionate about such as Orthopedics, Pelvic Health, Oncology, Vestibular, Hand, Pediatric, Neuro, Vertigo, Sports, Parkinson's Disease, Performing Arts, Pulmonary Disease, Concussion Management, Dry Needling (depending on state), and much more! Position Summary: Our Clinic Directors oversee all aspects of the clinic operations, manage clinical and non-clinical staff, and work with patients to provide individualized treatment and plans of care.
Associate Director, Formulation and Drug Product Development Dyne Therapeutics IncAssociate Director, Formulation and Drug Product DevelopmentWaltham, MA$159,000–$195,000 / yearThis role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne's strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials. Role Summary: The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne's bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability.
Director, Precision Medicine Regeneron Pharmaceuticals IncDirector, Precision MedicineCambridge, MA$205,000–$341,600 / yearAs a Director, a typical day may include the following: Program-level Precision Medicine lead that develops and implements the strategic vision for pharmacokinetic, pharmacodynamic, and exploratory biomarkers for clinical studies enabling indication and/or patient selection, early indication of biological activity, and to identify potential novel combinations. We are seeking to hire a Precision Medicine Scientific Lead to oversee the development and execution of biomarker strategies for novel cell therapies, cell transfer conditioning agents and combinations with bispecific antibodies across multiple disease areas (Oncology and Immunology).
Global Safety Program Lead/Sr Medical Director Alexion Pharmaceuticals IncGlobal Safety Program Lead/Sr Medical DirectorBoston, MA$280,895–$421,342 / yearLeads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset. Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.