- BeOne Medicines (San Mateo, CA)
- …study/project teams supporting hematology studies and interact with Clinical , Regulatory, Statistical Programming, Data Management and other Research ... data, developing and implementing the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission documents. Provides… more
- Bristol Myers Squibb (San Diego, CA)
- …apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of ... facilitates the transition of drug candidates from early to late-stage clinical development, their approval and life cycle management. Early-stage translational… more
- Gilead Sciences, Inc. (CA)
- …and non-interventional studies from concept approval to study closure: + Lead global , regional, and local Medical Affairs teams, Translational Medicine, Safety to ... out budget analyses, regulatory submission support and contract negotiations + Ensure clinical demand accuracy, clinical logistics preparation and Tech Ops… more
- Gilead Sciences, Inc. (Foster City, CA)
- …plans for large molecule bioanalytical method development, method validation, and clinical study sample analyses, which range from first-in human through approval ... activities during program implementation, bioanalytical design and input into clinical study protocols, bioanalytical method development, method validation, sample… more
- Sumitomo Pharma (Sacramento, CA)
- Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused on addressing patient ... on LinkedIn. **Job Duties and Responsibilities** + Lead on clinical studies and manage/provide training to team members when...protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** + Provide project/program management support on clinical development project teams. + Develop, validate and maintain project schedules ... + Develop, track, and manage the progress of the global development project to defined milestones. + Coordinate regular...+ Bachelor's Degree with 8 + years' experience in clinical and drug development in the biotech/pharmaceutical industry OR… more
- BeOne Medicines (San Mateo, CA)
- …sections for the assigned project to ensure on-time and high-quality global submissions for investigational, market, and post-approval applications. + Develop ... lifecycle for the assigned project. + Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project. + Provide… more
- Gilead Sciences, Inc. (Foster City, CA)
- …including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs ... process improvements and contributes to local and / or global process improvements, which have a significant impact for...assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs. + Must… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking an Associate Director / Director of Drug Substance Manufacturing for a direct hire opportunity with a leading ... Senior Director , $275,000 - $320,000 **Overview** As Associate Director / Director , Drug...process scale-up, regulatory strategy, and operational excellence required for clinical and commercial success. You'll thrive as part of… more
- J&J Family of Companies (Irvine, CA)
- …Global Strategic Marketing (GSM), Health Economics and Market Access (HEMA), and Clinical Affairs (CA). Associate Medical Director , under limited ... apply. We are searching for the best talent for ** Associate Medical Director , Cardiac Imaging.** **Role Purpose**...limited to: + Support the generation of preclinical and clinical evidence strategies to support clinical claims… more