- Sanofi Group (Cambridge, MA)
- …individual will also serve as Study Medical Manager (SMM) for selected clinical studies . SMM principal duties and responsibilities include:** Study ... **Job Title:** Clinical Lead , Early Clinical ...Dose Escalation Meeting and document decision making (for First-in-Human studies ). + Review the Adverse Event reports. Study… more
- Sanofi Group (Cambridge, MA)
- …and experts **Execution of clinical development and studies activities** + Lead and oversee study implementation and remediate study issues + Review ... medical input & support for all activities related to clinical studies such as medical training, feasibility,... clinical scientist, bio stat and GSO + Lead the study specific committees (IDMC, steering… more
- Sanofi Group (Cambridge, MA)
- …and maximize probability of success for implementation. In this role as a DBM Innovation Clinical Lead - Signal-Seeking Studies , you will design and lead ... health technologies with critical scientific assessment of their measurement properties and clinical applicability + Lead study execution with attention… more
- J&J Family of Companies (Cambridge, MA)
- …entry to Proof-of-Concept (PoC). The Associate Director, TM, will function as a clinical lead / study responsible physician on early development programs and ... development and biomarker science) and a clinical study responsible scientist. The span of studies ...Director will be part of the Translational Medicine Program Lead group which has primary responsibility within… more
- Sanofi Group (Cambridge, MA)
- …in the role of any of the following o Clinical Operations Lead , Clinical Project Manager, Clinical Study Manager, Global Study Manager, ... implementation, and success of a digital endpoint in a clinical study and/or program. Additionally, the role...on operationalizing selected Digital Health Technologies (DHTs) into our clinical studies for our growing digital biomarker… more
- Sanofi Group (Cambridge, MA)
- …select Exploratory Pharmacology studies ) and/or registries (eg: protocol, Key Results, Clinical Study Report) + Support other clinical development ... medical information for the study team, medical advisors/ Clinical Project Leaders from Clinical Study...medical spokesperson for the studies and project Lead the strategy and structure of the clinical… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Clinical Outcomes Assessment (COA) Lead **Location:** Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... helping our teams accelerate progress. The remit of the Clinical Outcome Assessment (COA) team at Sanofi is to...Ready to get started? **Main Responsibilities:** + The **COA Lead ** is accountable for the definition of COA endpoint… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and compliance in all US Medical activities. + Drive and deliver all aspects of clinical study execution from study concept to final reporting, coordinate ... and leadership to ensure successful operational execution of all US Medical Clinical Research including, Medical Affairs Company Sponsored Studies (MACS)… more
- Takeda Pharmaceuticals (Boston, MA)
- …these activities and is accountable for the successful design and interpretation of clinical studies . Presents study conclusions to Management and determine ... a significant impact on timelines or product labeling. Plans clinical development plans or study designs that.../ approval of synopses, protocols and the conduct of clinical studies . Serves as an advisor to… more
- Sanofi Group (Cambridge, MA)
- …as study management and publications. + Prior experience in clinical trials, RWE/Epidemiological studies including understanding of trial methodology, ... You** **Desired Skills and Competencies** + Extensive experience in research including clinical studies , RWEs and claims database analyses + In-depth knowledge… more