Director, Medical Safety Assessment Physician Bristol-Myers Squibb CoDirector, Medical Safety Assessment PhysicianMA$286,560–$347,244 / yearOversee, prepare and/or review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]). Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Director, Strategy & Operations and Congress Strategy Lead, U.S. SYFOVRE Apellis Pharmaceuticals IncDirector, Strategy & Operations and Congress Strategy Lead, U.S. SYFOVREWaltham, MA$199,000–$274,000 / yearSummary: The Director, Strategy & Operations and Congress Strategy Lead is a highly visible leadership role responsible for helping the U.S. SYFOVRE franchise translate strategy into execution, drive operational excellence, and maintain strong alignment across the commercial organization and key cross-functional partners. This role will serve as a trusted strategic partner to the VP, Head of U.S. SYFOVRE Business, helping to run the business, manage operating rhythm and governance, elevate executive communications, and ensure the franchise is positioned to deliver on its priorities with clarity, discipline, and agility.
Senior Director, Pharmacovigilance PV Sciences Keros Therapeutics IncSenior Director, Pharmacovigilance PV SciencesLexington, MA$245,000–$302,000 / yearLead and manage all medical safety and risk management related projects including planning, tracking and execution; provide vendor oversight for quality of ICSRs, similar case analysis, and aggregate safety reporting; lead initiatives from the scientific and PV regulation perspective such as inspection readiness, and launch readiness. The Senior Director, PV Sciences is responsible for safety surveillance and aggregate safety reports and works with PV physicians for signal/risk management for Keros products to support product safety and compliance with global drug safety regulations and functional procedures and provide vendor oversight to PV vendors.
Associate Director, Project Management Publicis Groupe SAAssociate Director, Project ManagementBoston, MA$97,375–$149,296 / yearOur project work includes experience design and development, digital and social media campaigns, digital partnership activations and promotions, eCommerce and CMS implementations, CRM programs, and branded content. To help with this, were looking for an outstanding Associate Director in Project Management a digital producer with a passion for using collaboration, the creative process, and emerging technologies to produce world-class interactive experiences for our clients.
National Sales Director, D-PLEX100 – US Institutional Sales (Surgical Business Unit) Azurity Pharmaceuticals - USNational Sales Director, D-PLEX100 – US Institutional Sales (Surgical Business Unit)Woburn, MARemoteThe Sales Force Director designs the sales model and deployment, recruits and hires the field team and its management layer, builds the training and onboarding program, and leads day-to-day sales execution across US hospitals and surgical facilities. The ideal candidate brings a minimum of 12 years in pharmaceutical or biotech, including significant hospital/institutional field sales experience and a proven record of building and leading field sales teams (first- and second-line leadership).
QA Compliance Manager Cipla LtdQA Compliance ManagerFall River, MA$86,000–$113,500 / yearAbout InvaGen Pharmaceuticals, a Cipla subsidiary: InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesBoston, MA$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Lead, Market Access Analytics, US Oncology (Associate Director) 3312 Takeda Pharmaceuticals AmericaLead, Market Access Analytics, US Oncology (Associate Director)Boston, Massachusetts$154,400–$242,550 / yearThe US Oncology Market Access Analytics Lead will leverage data across multiple sources to create analyses, synthesize results into actionable insights, and communicate the business impact to cross-functional stakeholders to shape US Oncology Business Unit (OBU) Market Access strategies and enable Market Access field teams. Main activities include analysis of data from above brand Hub/Patient Services Programs, Trade & Distribution Operations, State & Federal policies (PBM reform, MFN, etc), and other emerging US healthcare landscape trends that impact the Oncology therapeutic area.
Individual Giving Director, Global Social Impact & Disaster Relief World Central KitchenIndividual Giving Director, Global Social Impact & Disaster ReliefBoston, MA$120,000–$135,000 / yearPara empleados en los EEUU, WCK participa en E-Verify y proporcionará al gobierno federal la información de su Formulario I-9 para confirmar que usted está autorizado para trabajar en los EE.UU. Develop and execute ambitious annual and multi-year revenue plans across major, mid-level, and recurring giving, and lead the launch of WCK's planned giving program.
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.
Senior Medical Director, Pharmacovigilance Karyopharm Therapeutics IncSenior Medical Director, PharmacovigilanceNewton, MA$310–$380Our lead therapy, XPOVIO (selinexor), is a first-in-class inhibitor of exportin 1 (XPO1) and is approved in the U.S. for adults with relapsed or refractory multiple myeloma, with approvals in more than 50 countries and territories outside the U.S. We are also exploring opportunities to evaluate XPO1 inhibition across myeloproliferative neoplasms and TP53 wild-type driven solid tumors using next-generation compounds, including eltanexor. We are looking for talented people who are motivated by meaningful work, energized by growth and momentum, and excited by the opportunity to help shape what comes next in a collaborative, fast-moving environment where individual contributions are visible and valued.
Director, Strategy & Operations and Congress Strategy Lead, U.S. SYFOVRE Apellis PharmaceuticalsDirector, Strategy & Operations and Congress Strategy Lead, U.S. SYFOVREWaltham, MassachusettsThe Director, Strategy & Operations and Congress Strategy Lead is a highly visible leadership role responsible for helping the U.S. SYFOVRE franchise translate strategy into execution, drive operational excellence, and maintain strong alignment across the commercial organization and key cross-functional partners. This role will serve as a trusted strategic partner to the VP, Head of U.S. SYFOVRE Business, helping to run the business, manage operating rhythm and governance, elevate executive communications, and ensure the franchise is positioned to deliver on its priorities with clarity, discipline, and agility.
Director, Epidemiology CSL PlasmaDirector, EpidemiologyWaltham, PennsylvaniaContribute epidemiological data in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests). We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals IncDirector, Regulatory Affairs - Clinical StrategyWoburn, MABrief Team/Department Description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical Strategy will conduct in-depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. Principle Responsibilities: • Development and implementation of clinical regulatory strategies and tactics, including but not limited to, Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets, while considering FDA and other health authority clinical and regulatory requirements.
Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical StrategyWoburn, MADevelopment and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.
Associate Director, Investor Relations 5AM VenturesAssociate Director, Investor RelationsBoston, MAWorking alongside the Head of Investor Relations, this role is responsible for managing core investor communication infrastructure, driving fundraising execution across multiple strategies, and ensuring a best-in-class experience for current and prospective Limited Partners. The Investor Relations Manager is a key member of the firm’s IR and fundraising team, serving as a primary point of contact for Limited Partners, managing all communications, onboarding, documentation access, and event engagement to ensure a best-in-class LP experience.
Associate Director, Commercial Training PharmaEssentia U.S.A.Associate Director, Commercial TrainingBurlington, MA$175,000–$215,000 / yearFounded 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 Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung. This role will build and deliver high quality training and development experiences focused on selling skills, clinical knowledge, product skills, competitive knowledge, business acumen and management skills while continually evaluating the effectiveness of the programs.
NewSenior Director, Regulatory Strategy & Policy Galderma Group AGSenior Director, Regulatory Strategy & PolicyBoston, MA$240,000–$320,000 / yearServes as the U.S. FDA Regulatory Affairs strategic partner to the Global Heads of Regulatory Strategy (Therapeutic Dermatology, DS and IA), providing strategic leadership on FDA engagement, regulatory submissions, and Health Authority interactions to ensure alignment of U.S. regulatory strategy with global development objectives and successful product development and lifecycle management. Represents Global Regulatory Affairs (GRA) on core development and cross-functional project teams, collaborating with regional and global leaders to ensure a unified regulatory approach that supports FDA interactions and global commercial strategy.
Director, Deal Desk AppExtremes LLCDirector, Deal DeskBoston, MA$157,620–$252,190 / yearReporting to the Senior Director of Commercial Finance, you will lead a team of Deal Desk professionals-driving the commercial strategy, operational excellence, and cross-functional integration needed to support Conga's growth as a market-leading SaaS company. As a junior executive, you will set the vision and operating model for Deal Desk at Conga, partnering directly with the Chief Revenue Officer, SVP of Sales, VP of Legal, and CFO leadership to align deal operations with go-to-market strategy.
Lead, Market Access Analytics, US Oncology (Associate Director) Takeda Pharmaceutical Co LtdLead, Market Access Analytics, US Oncology (Associate Director)Boston, MA$154,400–$242,550 / yearThe US Oncology Market Access Analytics Lead will leverage data across multiple sources to create analyses, synthesize results into actionable insights, and communicate the business impact to cross-functional stakeholders to shape US Oncology Business Unit (OBU) Market Access strategies and enable Market Access field teams. Main activities include analysis of data from above brand Hub/Patient Services Programs, Trade & Distribution Operations, State & Federal policies (PBM reform, MFN, etc), and other emerging US healthcare landscape trends that impact the Oncology therapeutic area.