- Genentech (South San Francisco, CA)
- …to join the Medical network at Genentech. The Principal Medical (Science) Director will provide exceptional clinical and scientific leadership for medical affairs ... by leveraging relevant expertise and insights. + Execute US Medical/global clinical trial activities conducted as part of Medical Affairs. **Who you are** **Required… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Summary** The Director , Early Commercial Planning is responsible for supporting early-stage commercialization efforts, ensuring that Otsuka's pipeline ... of the pharmaceutical research and development process including clinical trial design and evidence generation concepts. + Cross-functional leadership skills,… more
- Bristol Myers Squibb (Brisbane, CA)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position Summary:** The ... + Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Job Description** Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Inflammation will lead the Biostatistics function within ... development process. In depth knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidance. + Proven ability to supervise team… more
- Abbott (Sylmar, CA)
- …of Medical Affairs and will contribute to product development, clinical trial planning and execution, regulatory support, quality oversight, and external engagement ... with key opinion leaders and professional societies. **WHAT YOU'LL WORK ON:** + Lead medical affairs activities for the core technology products (transvenous pacemaker (low voltage), transvenous ICD (high voltage), CRT, ICM(ILR), and Merlin.net. + Collaborate… more
- Pfizer (South San Francisco, CA)
- …clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results + ... Support execution for all FIH programs through proof-of concept + Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discusse relevant data to appropriate… more
- BeOne Medicines (San Mateo, CA)
- …8 years of combined experience in Feasibility, Clinical Data Analytics, Clinical Trial Management, and Operations Management. *Exceptions may be made for candidates ... with appropriate Clinical Operations experience All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. more
- BeOne Medicines (San Mateo, CA)
- …research activities for innovative statistical methods and applications in clinical trial development. **Other Qualifications:** + Experiences with clinical trials ... and knowledge of regulatory guidance are required. + Oncology experience is preferred but not required. + Demonstrated written and oral communication skills and ability to work within a team and work independently are required. + Other important requirements… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorizations for assigned product(s) and territories. + ... Responsible for ensuring preparation of the Product Company Core Data Sheets (CCDS), regulatory review of draft Product Company Core Safety Information (CCSI) and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner. + Responsible… more
- Gilead Sciences, Inc. (Foster City, CA)
- …safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for ... assigned territories. + Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products. + Contributes to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensures updates to the CCDS or CCSI are… more