- ACROBiosystems Inc. (Boston, MA)
- …cross-functional collaboration and continuous learning. Job Summary The Regional Account Executive/ Manager (Junior to Senior level) role is responsible for ... target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion… more
- argenx (Boston, MA)
- …alignment with our stakeholders, present concepts and results to project teams and senior management. All our studies are conducted in partnerships with leading CRO ... of study monitor. Coordinate contributions of other sponsor disciplines ( CMC , Bioanalytics, Pharmacokinetics). Collaborate with other scientific disciplines to… more
- argenx (Boston, MA)
- …of study monitor. Coordinate contributions of other sponsor disciplines ( CMC , Bioanalytics, Pharmacokinetics). Collaborate with other scientific disciplines to ... internal multidisciplinary project teams Present and contribute to discussions at senior management forums Actively contribute to the development strategy at… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …approvals or continued marketing. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... Help assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide statistical leadership in...Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality to explore methods and implement CMC… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under ... processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …functional business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors in our Cambridge office. ... to the GPL on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global… more
- Sanofi Group (Waltham, MA)
- …Functional Planner, Project Manager , CROs, etc.) + Under supervision of the senior manager of the TED team or Research lead, participates in project ... R&D for pre-clinical work, bioassay and biomarker research and/or CMC , biological assay, and biomarker research. He/She will work...lead statistician and provides support, with minimal supervision from manager or TED Global Head, to the… more
