- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage ... with regulatory authorities, and maintain clinical data integrity. The leader will be responsible for providing a compelling vision for the R&D Global Quality that… more
- AbbVie (Irvine, CA)
- …larger programs (late stage) + Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development , and discovery + Works closely ... (and could support one large product as the PST Lead ) and ensuring safety of late stage and post...required + 8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical +… more
- BeOne Medicines (San Carlos, CA)
- …bioanalysis to join our Clinical Biomarker laboratory. This role will lead the development , validation, and execution of quantitative and qualitative mass ... as well as hands-on experience in mass spectrometry-based biomarker method development , validation and clinical sample analysis. **Essential Functions of… more
- J&J Family of Companies (Irvine, CA)
- …Purpose** The Director will have medical affairs responsibility in providing therapeutic and clinical expertise in support of the development of medical devices ... global standards of care to deliver quality products/solutions. **What you will be doing:** ** Clinical Leadership** + Lead the support for all clinical … more
- Evolent (Sacramento, CA)
- …engagement strategies to improve the quality of care for oncology care services + Lead the development of new clinical interventions that increase value ... overall oncology service line activities including operational excellence, product innovation, clinical partnerships, and financial impact assessment + Lead … more
- Stanford University (Stanford, CA)
- …timelines and manufacturing schedules. Mainly focused on CART therapies. + Lead clinical materials manufacturing campaigns; responsible for oversight and ... include*:** + Lead CCT (Center for Cancer Cell Therapy) human clinical materials biomanufacturing campaigns as an operator or verifier. Prepare final formulated… more
- BeOne Medicines (Emeryville, CA)
- …who are in supportive roles for supply planning and business process development **Supervisory Responsibilities:** Lead comparator sourcing team for BeOne. ... Quality, CMC, Regulatory, etc.) stakeholders. + Demonstrates advanced knowledge of global clinical trials and the drug development process. + Experience in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …will provide operational and technical regulatory assistance through all stages of clinical development through global registration and maintenance, as needed. ... participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities. + Experience… more
- Bristol Myers Squibb (Brisbane, CA)
- …The selected candidate will have leadership responsibility for global regulatory strategy within a development team (DT). Serve as team lead or co- lead of ... documentation and Regulatory Project Reviews. Align regulatory plans with commercial and development plans + Develop target labeling and co- lead the… more
- J&J Family of Companies (Santa Clara, CA)
- …for a high-performing individual to join on our upstream marketing team to lead new peripheral product development projects. This individual will work with ... across multiple internal groups by collaborating with and influencing R&D, regulatory, clinical , quality, operations, sales, etc. + Lead market research to… more