- Ascendis Pharma (Palo Alto, CA)
- …skills, rigorous scientific intellect, and an understanding of the business aspects of drug development. At a personal level, the company is seeking a highly ... the JD. Key Responsibilities + Collaborate with Clinical Development, Pharmacovigilance, Biometrics , Core Team Members, Product Management, and Leadership teams to… more
- Sumitomo Pharma (Sacramento, CA)
- …programs, and liaises with Clinical (including Clinical Operations), Biometrics , Regulatory, Early Clinical Development, Pre-clinical research, Medical Affairs ... execution. + Provide clinical and medical expertise across all stages of drug development, from preclinical transition to post-marketing. + Stay abreast of emerging… more
- BeOne Medicines (San Mateo, CA)
- …with colleagues in clinical development, program leadership, biometrics , clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and ... and up to 2 studies in late development) + Seamless transition of drug candidates from research to early clinical development + Effective integration of in-licensed… more
- Bristol Myers Squibb (Brisbane, CA)
- …and Advanced Analytics to lead our Data Science team within the Global Biometrics and Data Sciences for Development organization. The ideal candidate will have a ... and enable exploratory insights for enhanced quantitative and model informed drug development + RWE Excellence: Provide executive leadership in leveraging RWD… more
- BeOne Medicines (San Mateo, CA)
- …with colleagues in clinical development, program leadership, biometrics , clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and ... Update Reports; + Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports; + Risks / benefits analysis for applicable… more
- BeOne Medicines (San Mateo, CA)
- …with colleagues in clinical development, program leadership, biometrics , clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and ... Update Reports + Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports + Risks / benefits analysis for applicable… more
- Bausch + Lomb (Sacramento, CA)
- …other B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics , Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug ... areas to provide input on study-related documents and issues (DMP, SAP, drug /device supplies, CSR, etc.). + Provides clinical operations input in the identification,… more
- BeOne Medicines (Emeryville, CA)
- …colleagues in global medical affairs, clinical development, program leadership, biometrics , clinical operations, and translational research. **Essential Functions of ... strongly preferred. + Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing. + High… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Evidence, Health Economics and Outcomes Research, Project Management, Regulatory, Biometrics , Clinical Research and Affiliates globally ensuring delivery of assigned ... long-range strategies, plans and objectives + Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable… more
- BeOne Medicines (Emeryville, CA)
- …with colleagues in clinical development, program leadership, biometrics , clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and ... Update Reports + Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports + Risks / benefits analysis for applicable… more