- AbbVie (South San Francisco, CA)
- …safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety ... a Safety Statistics Group Oncology TA Head in our Safety Statistics team. The Director will have oversight of statisticians in oncology. This role will be based out… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …for biologics/cell therapy. + Commercial experience in assay development for late-stage clinical trials and commercial manufacturing. + Strong background in ... help create more tomorrows. **Job Description** We are seeking a highly experienced Director of Analytical Operations to lead the Flow Assay Development Team within… more
- Lilly (San Diego, CA)
- …drug tailoring hypotheses in various autoimmune diseases that can be implemented in clinical trials . The position offers an outstanding opportunity to impact the ... our team. This role will contribute to discovery- and clinical -stage research in autoimmunity to enhance the understanding of...with program teams at various stages of discovery and clinical development. + Establish and maintain a laboratory that… more
- Gilead Sciences, Inc. (Foster City, CA)
- …analyses will include all stages of drug development from first-in human through Phase IV clinical trials . You will be responsible for the conduct as well as ... cross-functional partners.** **Responsibilities:** **Leading quantitative and innovative strategies within clinical pharmacology to impact MIDD during the life cycle… more
- BeOne Medicines (San Mateo, CA)
- …signal detection, integrated safety review, risk evaluation and safety operation using clinical trial , real-world and post-marketing surveillance data. + Partner ... key partner to drive data-driven operation and decisions with the clinical development stakeholders. **General Description:** We seek an experienced professional to… more
- Genentech (South San Francisco, CA)
- …novel cancer therapies, discover and develop novel biomarkers and strategies to support clinical trials , and derive new research directions and drug discovery ... This individual will work closely with leaders across Research, Early Clinical Development, Computational Sciences, and Development Sciences in gRED, and Product… more
- Sumitomo Pharma (Sacramento, CA)
- …or follow us on LinkedIn. **Job Duties and Responsibilities** + Lead on clinical studies and manage/provide training to team members when needed. + Contribute and ... SAS/SQL and SAS/ODS. + Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate +...quality. + Establish monitoring of data transfers for ongoing trials to identify study conduct or data + undefined… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …for planning and resource reporting tool related issues, updates, and enhancements. ** Clinical Trial Planning:** + Partnering closely with Project Managers to ... not limited to:_ **Resource Management & Reporting:** + Support Director of Business Strategy & Operations, extracting and analyzing...ensure clinical trial plans have accurate information, assist… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensuring submission 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… more
- Gilead Sciences, Inc. (Foster City, CA)
- …documents including 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… more