Medical Director, EP, Medical and Patient Safety Gateway RecruitingMedical Director, EP, Medical and Patient SafetyBoston, MAAs the clinical voice of the physician and patient, the Global Medical Director will partner with Clinical Research, Research and Development (R&D), Quality, Regulatory Affairs and Commercial teams to support innovation, clinical evidence generation, product development and patient safety. Partner with Clinical Research, Clinical Evidence, Quality, Regulatory Affairs, R&D, Marketing and Business Development teams to support product strategy and medical decision-making.
Director, Regulatory CMC bluebird bio, Inc.Director, Regulatory CMCSomerville, MA$204,000–$245,000 / yearThe Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late-stage gene therapy products, with a primary focus on lifecycle management, change management, and regulatory compliance. This role supports the development and delivery of post-approval regulatory strategies and ensures effective implementation of manufacturing, analytical, and control changes across global markets.
Sr. Director, Regulatory CMC bluebird bio, Inc.Sr. Director, Regulatory CMCSomerville, MA$156,000–$316,500 / yearThe Senior Director serves as a key regulatory partner to Technical Operations, Quality, and Supply Chain, and acts as the primary CMC regulatory interface with global health authorities for post-approval activities, including supplements, variations, annual reports, and inspection support. The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy products, with a strong emphasis on lifecycle management, change management, and sustained regulatory compliance.
Senior Medical Director, Global Drug Safety ReplimuneSenior Medical Director, Global Drug SafetyWoburn, Massachusetts$307,000–$397,000 / yearThis position provides pharmacovigilance expertise to and lead collaborations with external partners as well as with other functions across Replimune, including Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, or the Commercial to ensure that drug safety communications are accurate, complete and consistent. The 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.
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.
Manager, Regional Regulatory Lead - LCM CSL PlasmaManager, Regional Regulatory Lead - LCMWaltham, MassachusettsRegulatory 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.
Associate Dean, Program Development Covenant HealthAssociate Dean, Program DevelopmentNashua, New HampshireWork closely with the Provost, Deans, Faculty, Enrollment Management, Academic Affairs, Student Services, Finance, and Information Technology departments. Develop a comprehensive program blueprint, including curriculum structure, academic pathways, student progression models, and operational frameworks.
NewClinical Scientist, Neuroimmunology & Specialty Care, PDT 3316 Takeda Development Center AmericasClinical Scientist, Neuroimmunology & Specialty Care, PDTBoston, MassachusettsThis role will work within the Neuroimmunology and Specialty Care team to support development of clinical assets across the United States, the European Union, and Japan, including protocol concept and protocol development, study start-up and execution, data cleaning, preparation of clinical study reports, and contributions to regulatory filings. Proven experience preparing clinical study protocols, Clinical Study Reports, integrated clinical statistical reports, and clinical sections for regulatory submissions across multiple regions, including Investigational New Drug and New Drug Application documentation.
Change Control and Quality System Specialist Integrated Resources, IncChange Control and Quality System SpecialistLexington, MassachusettsContractorThis person will also assist with other quality system events which require regulatory CMC support (such as deviations, annual reports, inspections/audits, etc.) and act as a liaison with the Tech Ops organization. Collaborate and communicate with global CMC leads, EU and international regulatory colleagues to provide consistent, clear and timely assessments into the change control management system (50%).
Medical Manager - CNS Azurity Pharmaceuticals - USMedical Manager - CNSWoburn, MAAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. Medical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas.
Senior Clinical Research Director SanofiSenior Clinical Research DirectorCambridge, MA$236,250–$393,750 / yearCollaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. Collaborate with other CRDs within the project, ensure leadership, buildsconsensus, coordinate action plans with stakeholders to resolve project-related study issues, anticipate potential issues (sharing lessons learned) across the project or study teams.
Medical Director Clinical Development- Respiratory GSK plcMedical Director Clinical Development- RespiratoryWaltham, MA$222,750–$371,250 / yearIn addition to providing clinical and scientific leadership to clinical and translational studies or programs for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion, and innovative clinical development opportunities. Serve as the primary Clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators and with the relevant internal review boards (e.g., Technical Review or Governance) and/or Protocol Review Board.
Clinical Development Medical Director - Cardiovascular GSK plcClinical Development Medical Director - CardiovascularWaltham, MA$222,750–$371,250 / yearIn addition to providing clinical and scientific leadership to clinical and translational studies or programs for asset-level projects, you will contribute to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion, and innovative clinical development opportunities. Serve as the primary Clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators and with the relevant internal review boards (e.g., Technical Review or Governance) and/or Protocol Review Board.
NewDirector, Global Regulatory Labeling Strategy 3316 Takeda Development Center AmericasDirector, Global Regulatory Labeling StrategyMassachusettsRemoteConducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.
Director Of Financial Aid Benjamin Franklin Cummings Institute of TechnologyDirector Of Financial AidBoston, MA$85,000–$105,000 / yearThe Director also provides strategic oversight of the College's outsourced financial aid partner (FA Solutions), establishing performance expectations, monitoring service delivery, ensuring contractual compliance, and fostering a collaborative partnership that supports institutional goals and an exceptional student experience. As a key member of the Enrollment Services leadership team, the Director collaborates closely with Admissions, Student Accounts, the Registrar, Student Affairs, Finance, Information Technology, Academic Affairs, and external agencies to remove financial barriers and advance the College's enrollment and student success goals.
NewSenior Medical Director Oncology Early Development AbbVie IncSenior Medical Director Oncology Early DevelopmentWaltham, MAActs as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Director of Quality and Compliance EPS ConnectsDirector of Quality and ComplianceBeverly, MassachusettsWorking closely with the Vice President of Quality, you'll evaluate existing quality systems, identify opportunities for improvement, harmonize processes across global manufacturing sites, and help build a scalable quality organization capable of supporting continued expansion. EPS Connects is conducting a confidential search on behalf of a global medical device manufacturer seeking a Director of Quality & Compliance to help shape the future of its enterprise Quality Management System.
Change Management & Communications Lead Job Opportunity Integrated Resources, IncChange Management & Communications Lead Job OpportunityCambridge, MassachusettsContractorRMO Communication Deliverables: • "Walking Deck" – created for key stakeholders to be used as an elevator pitch to cascade information to impacted teams. • Coordinate activities with dependent projects, including Product Lifecycle Management (PLM) and End to End Artwork (ARTi) which are led by Company's Manufacturing (PO&T) organization.
Senior Engineer/Manager, Process Validation Stoke Therapeutics, Inc.Senior Engineer/Manager, Process ValidationBedford, MA$140,000–$161,000 / yearCollaborate with internal and external partners to develop and define key product lifecycle documentation, including quality attribute and process risk assessments (FMEAs), process control strategy documents, continued process verification control plans, etc. Using Stoke's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels.
Senior Director, Post Market Monitoring Job Details | Olympus Corporation Of The Americas OlympusSenior Director, Post Market Monitoring Job Details | Olympus Corporation Of The AmericasWestborough, MAThe Senior Director, Post Market Monitoring is accountable for developing and integrating advanced post market surveillance systems that combine external market intelligence, publicly available safety and regulatory data, scientific literature, real-world evidence, and internal quality data sources to generate actionable insights that improve product performance, patient safety, and regulatory compliance. The Senior Director will lead the implementation of AI-enabled analytics and signal detection capabilities that transform structured and unstructured data into meaningful risk intelligence, enabling the organization to identify trends, emerging risks, and new use cases before they escalate into significant quality, regulatory, or business risks.