- Amgen (South San Francisco, CA)
- …Join us and transform the lives of patients while transforming your career. **Scientific Associate Director - PKDM (Small Molecule ADME)** **What you will do** ... role you will oversee biotransformation activities and can serve as a project team representative focused on small molecule (SM) programs. You will characterize… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** The Associate Director , Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products at ... and transported in a controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role will direct Biologics… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Associate Director , Quality Systems & Architecture will be responsible for leading QMS strategy, including the developing, ... field (Engineering, Science, Math/Stat) + Minimum 10 years experience in Quality, Regulatory , or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The ** Associate Director ** **,** **Digital Clinical Operations** is responsible to enhance Global Clinical Operations' productivity and ... that are cohesive, efficient, reliable, and compliant with all applicable regulatory expectations. + Implement the GCO technology roadmap to increase Global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …improvements, procedural documents, and quality and inspection readiness for Clinical Operations. The Associate Director will be a key member of the Connect GCP ... support. + Lead Clinical Operations on internal deviations activities, including project management support for deviation management activities. + Provide guidance… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Change Management, Development provides strategic support and ... Clinical Development, Clinical Operations, Clinical Data Sciences, Medical Affairs, Regulatory Affairs and more. Additionally, this individual will enable and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …He/she will be responsible for the development and successful execution of project plans in support of the ISC strategies including network optimization, cost-out ... of possible** with us. As a strategic partner reporting to the Sr Director of Global Integrated Supply Chain (ISC), you'll connect platform teams with manufacturing… more
- BeOne Medicines (San Mateo, CA)
- Work with cross-functional study/ project teams supporting hematology studies and interact with Clinical, Regulatory , Statistical Programming, Data Management and ... meet analysis requirements, internal standard operating procedures, and external regulatory requirements. + Analyzes data and interprets results from clinical… more
- Pfizer (South San Francisco, CA)
- …field with 5 to 7 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency OR Masters or doctoral degree w Five or more years of relevant ... experience in a pharmaceutical, biotech, CRO, or Regulatory Agency + Understanding of drug development process and data operations required for the reporting of… more
- Sumitomo Pharma (Sacramento, CA)
- …of the problems. + Act as a liaison between statistical programming, subcommittees and project teams as + undefined + May serve as an external spokesperson for the ... using SAS + Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc. + Executing Pinnacle… more