- BeOne Medicines (Emeryville, CA)
- …play a critical role in safeguarding the integrity, safety, and quality of clinical research processes and data . This position requires: + Extensive knowledge ... and applicable global & local regulations and guidance for clinical development. + Strong global mindset and knowledge about...that mitigate risks to the company, to safety and data integrity. + Extensive experience in managing GCP investigations.… more
- AbbVie (South San Francisco, CA)
- …Associate Director, Statistics - Oncology provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. ... Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA)....or those of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide statistical leadership… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for small molecules + Drive development and implementation of new systems to improve project execution and data management + Lead collaborations with Gilead PDM ... of activities across all development stages (lead optimization of pre- clinical drug candidates, preformulation, formulation development, process scale-up, technology… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in HIV prevention. The ideal candidate will have previous experience in clinical and operational research, and significant knowledge in HIV Prevention. This position ... MA Scientific Leads, and key cross-functional partners such as clinical operations and local affiliates. This will include the...to ensure inclusion of ISR and CO studies in data generation plans + Prepare presentation materials related to… more
- Astellas Pharma (South San Francisco, CA)
- …Controls), as well as external collaborators. 3. Prepare patent specifications related to non- clinical pharmacology data for patent filings of drug candidates as ... of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We… more
- Bristol Myers Squibb (Brisbane, CA)
- …experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience ... with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. Provides guidance and management to statisticians to… more
- Norstella (Sacramento, CA)
- …our highly complex, rapidly evolving marketplace lacking transparency to enable our pharmaceutical and biotech clients to make better decisions and flourish. Today, ... structure and logic of the strategy consulting discipline, bolstered by our robust data set continuously enriched via our unequaled specialty access panel of the… more
- BeOne Medicines (San Mateo, CA)
- …environment including regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions ... cross functional influence and acts as an advisor/liaison to the global project teams to plan, evaluate and recommend regulatory strategy. Externally, the individual… more
- Bristol Myers Squibb (Brisbane, CA)
- …+ Prepare content for regulatory strategic documentation and Regulatory Project Reviews. Align regulatory plans with commercial and development plans ... plans. + Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents,… more
- Pfizer (South San Francisco, CA)
- …To ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical ... development. + Understanding of related disciplines (eg, biostatistics, regulatory, pre- clinical pharmacology, pharmaceutical sciences). + Demonstrated scientific… more