- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Study Data Leader **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The ... families. Your skills could be critical in helping our teams accelerate progress. Global Study Data Leader is responsible for leading the end-to-end… more
- Sanofi Group (Cambridge, MA)
- …publish the results and scientific insights arising from observational studies . + Lead the development of analyses based on data available from various ... research studies , as well as providing consultation on epidemiological study designs including statistical plans. The successful candidate will lead … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** PSPV Global Translational Safety Lead **Location** : Cambridge, MA or Morristown, NJ **About the Job** Are you ready to shape the future of ... and evaluation to patient risk profiling, patient safety experience and clinical data . + Collaborate within Global Pharmacovigilance for optimizing signal… more
- Sanofi Group (Cambridge, MA)
- …what you thought was possible. Ready to get started? **Main Responsibilities** + Lead the preparation, review, and maintenance of global labeling strategy and ... information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy… more
- Sanofi Group (Cambridge, MA)
- …approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study ... analysis strategies to further define the safety as well as Benefit Risk profile. + Lead the review of aggregate safety data and related activities as well as… more
- Takeda Pharmaceuticals (Boston, MA)
- …spend related to study execution. Works closely with Clinical Operations Program Leader (s), Global Program Management, and Finance to ensure on a regular ... a necessary contributor to our inspiring, bold mission. **_GOALS:_** Lead study operational strategy and planning and...clinical studies or Phase 2 and 3 studies and global /international studies or… more
- Sanofi Group (Cambridge, MA)
- …regulators, and experts **Execution of clinical development and studies activities** + Lead and oversee study implementation and remediate study issues + ... and cluster feasibility, medical review and validation of clinical data , study risk assessment + Support and...potential issues (sharing lessons learned) across the project or study teams. We are an innovative global … more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Lead or support Investigator Initiated Studies (IISR) program. + Lead and execute global advisory board meetings and assure communication of key ... director will provide scientific & team leadership, guidance across global medical affairs activities including evidence data ...& HCPs relevant to assigned therapeutic area and molecules. Lead or support development & execution of global… more
- Takeda Pharmaceuticals (Boston, MA)
- …to meet them. + Responsible for high impact global decisions: interpreting data from ongoing internal and external studies , assessing the medical and ... Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate...Head to provide strategic clinical input on assigned clinical studies . + Leads the Global Development Team… more
- Sanofi Group (Cambridge, MA)
- …Immunology & Inflammation (I&I) as Associate Statistical Project Leader ** and you will lead several I&I phase 2 or 3 studies under minimum supervision of ... the clinical study (including protocol development), the setup and conduct of the study to make sure data are adequately captured and collected to answer the… more
- Bristol Myers Squibb (Cambridge, MA)
- …assigned programs. Key responsibilities of this role are to act as a lead scientist to deliver and implement biomarker strategies for clinical programs, develop ... reports and publications on preclinical and translational data generated to support asset development and contribute to regulatory submissions. This individual will… more
- Sanofi Group (Cambridge, MA)
- …for a study or clinical program as well as reviewing and monitoring study data . + Provide appropriate medical input & support for all activities related ... clinical studies such as medical training, feasibility, medical review of data , documents, medical information/communications for the study team and other… more
- Sanofi Group (Cambridge, MA)
- …knowledge for immunology, and to incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with ... and full clinical study protocol + Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations + Review… more
- Sanofi Group (Framingham, MA)
- …shared commitment to improving the lives of patients. Sanofi, an integrated global healthcare leader , discovers, develops and distributes therapeutic solutions ... information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy… more
- Sanofi Group (Cambridge, MA)
- …activities (eg pressure test and cluster feasibility, medical review and validation of clinical data , study risk assessment) + Contribute to the clinical part of ... the project, ensuring the medical relevance of the clinical data across all studies with the project....the project or study teams. He/she raises study or project-level issues to the Global … more
- Sanofi Group (Cambridge, MA)
- …with your personal email address. **About the job** _As_ **_Regulatory Affairs Innovation Lead VIE_** _within our Global Regulatory Operations team, you'll be at ... **Regulatory Affairs Innovation Lead - VIE Contract** + _Location: USA, Cambridge_...genetic testing) or any other characteristic protected by law. Global Terms & Conditions and Data Privacy… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … generation plans aligned with brand and market access strategy + Acts as a study Medical Lead for the GMA Medical Affairs Company Sponsored / Collaborative ... + Leads flagships medical programs as defined by the Global Medical Affairs (GMA) Strategy Team and sub-teams +...and provide medical oversight and monitoring for Phase 3b/4 studies + Develops and maintain relationships externally through Advisory… more
- Sanofi Group (Cambridge, MA)
- …for research studies , ensuring a diverse and representative sample. **Analyzing Data :** + ** Data Analysis** : Identify patterns, trends, and insights from ... information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy… more
- Takeda Pharmaceuticals (Boston, MA)
- …appropriate comparator + Co- lead with Market Access the development of the global value proposition to ensure a compelling value story for payers + Identify and ... LOCs on product value platforms, new evidence and HE studies and models + Co- lead with Pricing...Responsibility in line with Associate Director level position; independently lead HE projects and support the Global … more
- Sanofi Group (Cambridge, MA)
- …found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and ... Data Privacy Statement (https://www.sanofi.com/en/careers/ global -terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges.… more