- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …**Job Description** **Position Summary** Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience ... commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior...clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, ... **Job Summary** The Senior Manager of Global Quality Management...throughout the clinical development lifecycle. **Key Responsibilities** ** Clinical Study Support** + Serve as a… more
- Sanofi Group (Cambridge, MA)
- …is to: + Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs + Collaborate with other medical and ... **Job Title:** Senior Clinical Research Director **Location:** Cambridge,...medical input & support for all activities related to clinical studies conduct such as answers to… more
- ConvaTec (Lexington, MA)
- …guidelines, and regulations. + Working closely with the Global Head of Clinical Operations, develop study level operational strategy and clinical ... policies and SOPs. **Key Responsibilities:** + Working closely with Clinical Study Managers (CSMs) and Clinical...Clinical Research Organizations (CROs) and other vendors for clinical studies that are outsourced to third… more
- Takeda Pharmaceuticals (Boston, MA)
- …integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration.../ approval of Synopses, Protocols and the conduct of clinical studies . Serves as an advisor to… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA **About the Job** Join the engine of Sanofi's mission - where deep ... could turn the impossible into possible for millions. The Senior Clinical Research Director (CRD) is an...to the cross functional project team to conduct the clinical studies from early phases to LCM… more
- Sanofi Group (Cambridge, MA)
- …select Exploratory Pharmacology studies ) and/or registries (eg: protocol, Key Results, Clinical Study Report) + Support other clinical development ... you thought was possible. Ready to get started? The Senior Clinical Research Director (Sr CRD) is...medical input & support for all activities related to clinical studies such as medical training, feasibility,… more
- Parexel (Boston, MA)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical ... in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical … more
- Bristol Myers Squibb (Cambridge, MA)
- …and execution of multiple clinical trials (eg significant experience as a senior clinical leader), and exhibits all of the following attributes: + Able ... . The Clinical Development Lead sits within Clinical Development, which is a global organization...studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and ... management of Otsuka clinical studies , including coordination with other relevant...Contribute to the development and review of all critical clinical study documents, including clinical … more