NewManager, Product Complaint Kiniksa PharmaceuticalManager, Product ComplaintLexington, MA$131,500–$146,500 / yearThis role is responsible for complaint intake, investigation coordination, complainant follow-up, quality metric reporting, and general QA Operations support while partnering with internal teams and external manufacturers, laboratories, device suppliers, and distribution partners to ensure timely, compliant, and inspection-ready complaint handling. This role is intended to strengthen Kiniksa's product complaint process by ensuring complaints are assessed, investigated, documented, trended, and closed in a timely and compliant manner across internal functions and external partners.
Senior Manager, Sales Training Integra LifeSciences Holdings Corp.Senior Manager, Sales TrainingMansfield, MA$125,350–$172,500 / yearReporting to the Vice President of Marketing, this is an individual contributor role that will partner with sales, global and regional marketing, global commercial operations, sales training peers from other business units and other critical cross-functional business partners to drive robust sales training initiatives that align to commercial needs and business priorities. Classroom/Face-to-Face Programs: Develop, coordinate and deliver an adult-training curriculum with a focus on interactive, engaging mechanisms for sales team members with coordinated support of Sales Leadership, Field Sales Trainers, Marketing, Medical Affairs, Global Commercial Operations and other key personnel.
Head of Regulatory, AM & D PhilipsHead of Regulatory, AM & DCambridge, MA$171,000–$273,000 / yearPartner cross-functionally to integrate regulatory requirements into product development and business processes, leading regulatory planning, risk assessments, and compliance strategies while driving continuous improvement initiatives that enhance operational efficiency, quality, and regulatory outcomes. Drive regulatory compliance and market access across the product lifecycle, overseeing global product registrations, approvals, CE Marking, clinical evaluations, regulatory submissions, and change management activities to ensure timely commercialization and sustained compliance in international markets.
Director, Regulatory Advertising & Promotion PharmaEssentia U.S.A.Director, Regulatory Advertising & PromotionBurlington, MA$184,620–$239,700 / yearThe Director partners closely with Commercial, Medical, Legal, Compliance, Regulatory, and other cross-functional stakeholders to ensure promotional strategies and materials are scientifically accurate, appropriately substantiated, aligned with approved labeling, and compliant with FDA/OPDP, FTC, the PhRMA Code, internal policies, and other applicable requirements. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchange (6446) and are expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung.
Thought Leader Liaison, Northeast Ipsen SAThought Leader Liaison, NortheastBoston, MA$190,000–$225,000 / yearTo be successful: the TLL team members will build close working relationships with, but not limited to: National Sales Directors, Regional Business Directors, Neuroscience Specialty Representatives, Medical Science Liaisons, Marketing teams, and Value & Access teams to ensure alignment on broader business objectives in their assigned regions. The position focuses on building and maintaining strong relationships with established and emerging thought leaders, generating actionable market insights, and driving advocacy for Ipsen's Neuroscience portfolio across Adult Spasticity, Cervical Dystonia, Pediatric Spasticity, and future anticipated indications such as Migraine.
Director, Global Medical Lead, Zasocitinib - Psoriatic Arthritis (PsA) Takeda Pharmaceutical Co LtdDirector, Global Medical Lead, Zasocitinib - Psoriatic Arthritis (PsA)Cambridge, MA$192,400–$302,390 / yearLead and influence a global, cross-functional medical matrix across Clinical Development, Regulatory, Pharmacovigilance, Commercial, Market Access, Health Economics and Outcomes Research (HEOR), Digital/Data & Technology (DD&T), regions, and affiliates to ensure medical leadership is embedded in key product decisions. Provide Director-level medical leadership and strategic counsel to the GPT, GMUH, Rheumatology, and senior cross-functional stakeholders on product profile, data interpretation, benefit-risk, evidence gaps, and external scientific dynamics.
Sr. Specialist, Regulatory Affairs LeMaitre Vascular IncSr. Specialist, Regulatory AffairsBurlington, MA$110,000–$150,000 / yearProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
Manager, Regional Regulatory Lead - LCM CSL PlasmaManager, Regional Regulatory Lead - LCMWaltham, Massachusetts$129,000–$153,000 / yearRegulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Developing regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products.
Director, Regulatory Advertising and Promotion Genetix Biotherapeutics IncDirector, Regulatory Advertising and PromotionSomerville, MA$185,000–$285,000 / yearThe Director serves as a key regulatory partner to Medical Affairs, Commercial, Marketing, and Legal, and plays a central role in promotional material review in a highly regulated environment, for cell and gene therapy products. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
Clinical Regulatory Specialist Iterative HealthClinical Regulatory SpecialistCambridge, MAYou will collaborate with site teams, internal stakeholders, sponsors, CROs, IRBs, and other external partners to ensure regulatory requirements are completed accurately, efficiently, and in accordance with applicable guidelines and study requirements. Working under the direction of a Clinical Regulatory Manager Director, you will partner closely with clinical research sites to manage regulatory activities throughout the study lifecycle—from study start-up and activation through ongoing maintenance and closeout.
Director, Clinical Affairs of Coronary/Vascular PhilipsDirector, Clinical Affairs of Coronary/VascularBedford, MA$171,000–$273,000 / yearYou're the right fit if: You've acquired 10+ years of directly related clinical or scientific experience, including leadership or management experience within the medical device industry, and 5+ years managing a clinical research functional team with a proven track record delivering complex clinical programs on time, within budget, and in compliance with applicable requirements. Your skills include comprehensive knowledge of clinical research regulations across multiple regions, FDA medical device regulations, medical device clinical trial practices, Good Clinical Practice, informed consent requirements, regulatory documentation, and the clinical evidence requirements needed to support regulatory, product development, and commercial objectives.
Director, HCP Marketing - DMD Dyne Therapeutics IncDirector, HCP Marketing - DMDWaltham, MA$188,000–$240,000 / yearSupport Regional Market Development Managers as primary field executors for peer-to-peer programming and KOL engagement (e.g., congresses, advisory boards, speaker programs), ensuring strategic alignment, compliant materials and training, and consistent capture of field insights to inform ongoing optimization. Serve as core member of the US Marketing Team, partnering closely with Medical & Scientific Affairs, Market Access, Patient Services, Legal, Regulatory, and Compliance to ensure HCP strategy aligns to the scientific narrative, access realities and patient support model.
Director, US Regional Marketing ENT & Instruments Integra LifeSciences Holdings CorpDirector, US Regional Marketing ENT & InstrumentsMansfield, MA$166,750–$228,850 / yearReporting to the Vice President of Marketing, this role develops and executes integrated commercial and marketing strategies that accelerate core growth, ensure successful product launches, and strengthen competitive positioning across capital equipment and disposable product segments. As a key cross-functional leader, the Director aligns Sales, Global Strategic Marketing, Commercial Operations, Professional Education, Sales Training, Medical Affairs, and Health Economics & Outcomes Research teams to drive market development, surgeon engagement, and commercial execution across the US market.
Manager/Senior Manager, Clinical Data Management Beam TherapeuticsManager/Senior Manager, Clinical Data ManagementCambridge, MA$130,000–$190,000 / yearBeam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. Reporting to the Senior Director of Data Management, this role is responsible for driving study-level data management activities from study start-up through database lock while ensuring high-quality, inspection-ready clinical data.
Director, Clinical Affairs Of Coronary/Vascular PhilipsDirector, Clinical Affairs Of Coronary/VascularBedford, MA$171,000–$273,000 / yearYou're the right fit if: You've acquired 10+ years of directly related clinical or scientific experience, including leadership or management experience within the medical device industry, and 5+ years managing a clinical research functional team with a proven track record delivering complex clinical programs on time, within budget, and in compliance with applicable requirements. Your skills include comprehensive knowledge of clinical research regulations across multiple regions, FDA medical device regulations, medical device clinical trial practices, Good Clinical Practice, informed consent requirements, regulatory documentation, and the clinical evidence requirements needed to support regulatory, product development, and commercial objectives.
Senior Director, Analytical Research & Development Third Rock Ventures LLCSenior Director, Analytical Research & DevelopmentBoston, MA$230,000–$270,000 / yearProvide technical leadership for analytical method development, validation, and transfer for DS and DP, utilizing techniques including (but not limited to) HPLC-CAD, HPLC-UV, GC, LC-MS, LC‑MS/MS, HPLC-FLR, LC-qToF, GC (Residual Solvents), Elemental impurity analysis, IR, qNMR, thermal analysis, droplet size, PSD, lipolysis, and dissolution/ drug release. The Senior Director, Analytical R&D, reports to the Vice President, CMC and is responsible for providing strategic and technical leadership for analytical development of small molecules within Seaport's portfolio, from pre-clinical development to late-stage clinical development.
Director, Analytical Development Ardelyx IncDirector, Analytical DevelopmentWaltham, MA$211,000–$257,000 / yearPosition Summary: The Director, Analytical Development is a leader who works as a member of an integrated team at Ardelyx overseeing small molecule analytical activities involving commercial drug substance and drug product with the exception of stability program management. This position partners cross-functionally with CMC, Quality, Manufacturing, Regulatory Affairs, Supply Chain, and external partners to ensure the successful execution of analytical strategies that support reliable product supply, regulatory compliance, and business objectives.
Veeva RIM Consultant Katalyst HealthCares & Life Sciences IncVeeva RIM ConsultantBoston, MAThe consultant collaborates with Regulatory Affairs, Quality, IT, and business stakeholders to enhance Veeva RIM capabilities, support digital transformation initiatives, and improve regulatory operations through automation and data integrity. The Veeva RIM Consultant is responsible for supporting and optimizing Veeva Regulatory Information Management (RIM) solutions within a regulated pharmaceutical or biotechnology environment.
Senior Director, Program Leader, Corporate Strategy Agios PharmaceuticalsSenior Director, Program Leader, Corporate StrategyCambridge, MA$229,562–$344,345 / yearDemonstrated ability to drive successful product launch and commercialization of innovative, first-in-class therapies, including lifecycle management (LCM) planning and execution; experience leading programs from late-stage development through commercial readiness and post-launch LCM strategies strongly desired. Cross-Functional Leadership & Execution Lead the Program Team, building a cohesive, high-performing cross-functional team that includes, but is not limited to, Clinical Development, Regulatory Affairs, Commercial, Medical Affairs, Manufacturing/CMC, Market Access, Finance, Legal, and Program Management.
Associate Director, Medical Safety CRISPR Therapeutics AGAssociate Director, Medical SafetySouth Boston, MA$170,000–$190,000 / yearThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. The Associate Director, Medical Safety is responsible for medical and clinical oversight of individual case safety reports (ICSRs), signal detection and evaluation, and benefit-risk assessment for the company's cell and gene therapy (CGT) / CRISPR-based product portfolio.