- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... among functions represented at the Labeling cross functional teams, including clinical , safety, medical affairs , and commercial, to ensure unparalleled… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides strategic ... emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all the clinical development… 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... agency interactions + Develop or contribute to the regulatory documentation for the project(s), provide clinical … more
- Philips (Cambridge, MA)
- …other publications to advance industry knowledge and visibility. + Manages the Clinical Affairs Annual Operating Plan (AOP), overseeing fiscal allocations, ... of our talented Hospital Patient Monitoring (HPM) CMO, the Clinical Development Portfolio Director is responsible for...represents Philips internally and externally as an ambassador for Clinical Affairs . + Oversees the handling of… more
- Merck (Boston, MA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May Be Responsible For:** + Evaluating pre- clinical and… more
- Sanofi Group (Cambridge, MA)
- …strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug ... **Job title:** Clinical Research Director in Immunology &...ICH guidelines and other regulations + Review documents supporting clinical development such as Investigator's brochure, regulatory … more
- Takeda Pharmaceuticals (Lexington, MA)
- …as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... to the best of my knowledge. **Job Description** **About the Role:** The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical & Quality Process Compliance is responsible for ensuring the ... + Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of regulatory guidance ... you and empower you to shine? Join us as Director , Quantitative Clinical Pharmacology (QCP) Lead in...(eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in… more
- Takeda Pharmaceuticals (Boston, MA)
- …will inspire you and empower you to shine? Join us as a Executive Medical Director , Oncology Clinical Sciences in our Cambridge office. At Takeda, we are ... Development Plan (IGDP). Responsible for review of synopses, other relevant clinical study documents and Critical Study Results. Provide leadership and oversight… more