- Takeda Pharmaceuticals (Cambridge, MA)
- …mechanisms of action and drug response. + Lead Translational Biomarker strategy development and execution to support the pre- clinical and clinical stage ... Product Teams, and Medical sub-teams through all stages of discovery, clinical development , and post-market activities. Secure implementation and delivery of… more
- Sanofi Group (Cambridge, MA)
- …requested to lead GRT meetings. + Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product ... regulatory expertise to contribute to the definition of the global regulatory strategy , to enable and drive...internal business partners, including but not limited to the clinical development teams, commercial and GRT for… more
- Sanofi Group (Cambridge, MA)
- …familiarity with standard submission processes + **Technical Knowledge:** Understanding of clinical development of medicinal products, device (including design ... across the product lifecycle. Our department bridges the gap between technical development , manufacturing operations, and global regulatory authorities to ensure… more
- Sumitomo Pharma (Boston, MA)
- … global guidance and monitoring of global regulatory line items in the clinical development projects budget process + Serve as the senior point of contact ... team based outcomes + Ability to provide motivational leadership to help the global regulatory organization understand the company's strategy and future +… more
- IQVIA (Boston, MA)
- …internal brainstorms, key client strategy and planning sessions, and Summit Global Health strategy /planning sessions. Development of Scientific Content + ... strategy . + Designs and leads the content strategy for Summit Global Health with clients....external sources for inclusion as a resource for content development . + Reviews clinical regulatory documents and… more
- Sanofi Group (Cambridge, MA)
- …Diseases will gain meaningful expert insights that influence priority areas of the Clinical Development and the product Life Cycle Planning teams in support ... closely with the leadership of Sanofi Genzyme's US and Global Medical, Clinical Research, Commercial and Product...Neuroimmunology, Multiple Sclerosis and/or Neurology + Experience in both clinical development and patient care preferred +… more
- Lilly (Boston, MA)
- … clinical strategies, development plans and study protocol designs. + Contribute to global alignment of clinical strategy and clinical plans with ... renal diseases. We are looking for physician/scientists to provide clinical development leadership to a rapidly expanding...The Executive Director will also supervise the implementation of global clinical trials; the reporting of adverse… more
- Sanofi Group (Framingham, MA)
- …plan aligned with the Global Project Team objectives from early phases of clinical development through the first approvals. We are an innovative global ... Global CMC Project Management group within R&D CMC Development , the CMC Project Leader is responsible to develop...represents CMC as a core team member in the Global Project Team, contributing to the program strategy… more
- Sanofi Group (Cambridge, MA)
- …Joint Ventures, including strategy and program execution. + **Business Strategy Development ** : Ensure medical representation on Product Business teams ... accelerating proper integration of our cutting-edge science into US clinical practice. We are an innovative global ...: Oversee the US medical affairs Solid Tumor Oncology clinical trial program, ensuring strategic development of… more
- Pfizer (Boston, MA)
- …outcomes assessment strategy and incorporate humanistic and economic endpoints into clinical trials across all phases of product development to build ... will be responsible for developing and executing against the global evidence generation strategy , including direct oversight...development and execution of the Value & Evidence Strategy (VES) to support the value of hematology assets… more