- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs , Global Clinical Development (late phase), Data & ... **Job Summary** The Senior Director will serve as the Translational Medicine CNS...Analytics, Early Commercial, Medical Affairs , Nonclinical Toxicology, Clinical Pharmacology, CMC,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Sanofi Group (Cambridge, MA)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA **About the...the Senior CRD is to: + Provide ophthalmology focused medical and scientific expertise to the cross functional project… more
- Sanofi Group (Cambridge, MA)
- …Research Director , Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical ... **Job Title:** Development Scientific Director (DSD) **Location:** Cambridge, MA, **About the Job**...to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and… more
- Philips (Cambridge, MA)
- …Japan and China. + You have a detailed understanding of Clinical & Medical Affairs , leveraging expertise to propose innovative ideas, providing meaningful input ... have proven experience leading management activities relationships within the Clinical and Medical functions, as well as cross-functionally with Regulatory , R&D,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …direction to a direct report responsible for day-to-day execution. While initially focusing on Medical Affairs , the vision is to cover all R&D HCP engagement ... championing the use of technology and AI to support workflow improvement across Medical Affairs and R&D **Team Leadership and Operational Oversight** + Directly… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Director will lead a cross-functional team, working closely with market access, sales, medical affairs , regulatory , and commercial excellence to align on ... + Strong cross-functional collaboration skills, with experience partnering across market access, medical affairs , and sales teams + Financial acumen, with… more
- State of Massachusetts (Boston, MA)
- …of Insurance ("DOI"), an Agency within the Office of Consumer Affairs and Business Regulation, administers the Commonwealth's insurance consumer protection laws ... their skills and talents to serve our citizens. *_About the Role:_* The Director of Pharmacy Benefit Manager Oversight operating within the Health Care Access Bureau… more