- BeOne Medicines (San Mateo, CA)
- … closure budget, budget endorsement by senior management + Adheres to clinical study budgeting processes and provides input to finance on budget accruals ... Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor)...over the study life cycle + Ensures clinical studies at a project level are… more
- Vera Therapeutics (Brisbane, CA)
- …Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory aspects of clinical studies in early-to-late development to create high quality ... Title: Senior Manager, Clinical Regulatory Location: Brisbane,...for submission, ensuring complete regulatory content that meets current regional requirements * Represent clinical Regulatory Affairs… more
- BeOne Medicines (San Mateo, CA)
- …internal partnership across the organization. The candidate will report to the Senior Regional Director, Solid Tumor- Breast Cancer, within Medical Affairs. ... with responsibilities similar to those of a **Medical Science Liaison** . The ** Senior Field Medical Director (SFMD)** will support BeOne Medicines USA, Inc. Breast… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Study applications, SRD & IDE applications, HA briefing books, clinical protocols, study reports, ICFs, Investigator Brochures, IND applications, CTAs, ... Join Gilead and help create possible, together. **Job Description** As an Senior Manager, Global Regulatory Affairs, Precision Medicine, you will help develop and… more
- BeOne Medicines (San Mateo, CA)
- …and study levels + Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core ... , for early to late-stage medicines development across global clinical operations (GCO). Good understanding of global, regional...across study teams and programs to accelerate study execution. + Partners with global clinical … more
- BeOne Medicines (San Mateo, CA)
- …ensuring internal partnership across the organization. The candidate will report to the Senior Regional Director, Solid Tumor - GI, within Medical Affairs. As ... . The **Field Medical Director (FMD)** will support BeOne Medicines pre- clinical and clinical pipeline development by coordinating external collaborations,… more
- Stanford Health Care (Palo Alto, CA)
- …of clinical results as appropriate; and present at local, regional and national research meetings/conferences as appropriate. + Reports on activities and ... which serves patients across the world. Its robust network of seven clinical sites staffed by Stanford's team of renowned surgical oncologists, medical oncologists,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …methodological advances and trends to ensure best approaches are used in relevant studies and evaluations. + Engage key clinical , methodologic, and TA experts ... LIVE including leading and supporting Gilead Sponsored and Collaborative studies , and serving as the Team Lead for the...(ET). The ideal candidate will have previous experience in clinical and operational research, and significant knowledge in one… more
- BeOne Medicines (San Mateo, CA)
- …but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory ... the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to...the US and Canada. + Supports the NA hematology regional team to negotiate with the US FDA as… more
- BeOne Medicines (San Mateo, CA)
- …including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... are met including the review global submission documents in support of clinical trials and marketing applications, and their amendments to support investigational… more