- Sumitomo Pharma (Sacramento, CA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... submissions and working with regulatory templates + Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical… more
- AbbVie (South San Francisco, CA)
- …must be local to San Francisco, CA or Lake County, IL. The Associate Director of Exploratory Statistics provides statistical leadership in drug discovery ... and patient selection or stratification to advance precision medicine. The associate director role collaborates with discovery researchers, translational… more
- Bristol Myers Squibb (Brisbane, CA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Global Regulatory Strategy, Neuroscience** **Position Summary:** ... etc. + Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in… more
- BeOne Medicines (Emeryville, CA)
- …staffing levels that will enable the delivery of the BeOne clinical trial portfolio. Reporting to the Director of Global Resource Management, this individual ... algorithm development to model future resource demand for various roles within clinical development. The role will also focus on analyzing data and generating… more
- BeOne Medicines (San Mateo, CA)
- …healthcare discipline* with minimum of 8 years of combined experience in Feasibility, Clinical Data Analytics, Clinical Trial Management, and Operations ... analytics and systems, the Global Strategic Feasibility Analytics Lead collaborates with clinical development and clinical operations stakeholders to foster a… more
- BeOne Medicines (San Mateo, CA)
- …Involved in research activities for innovative statistical methods and applications in clinical trial development. **Other Qualifications:** + Experiences with ... cross-functional study/project teams supporting hematology studies and interact with Clinical , Regulatory, Statistical Programming, Data Management and other Research… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** Otsuka is looking for a strong Clinical Statistician in the Medical and Real World Data Analytics organization to provide statistical expertise for ... analysis of clinical trials data beyond the study endpoints, including secondary,...in primary roles as statistician or lead statistician in trial design and analyses. + Experienced in developing statistical… 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
- 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
- J&J Family of Companies (Irvine, CA)
- …(R&D), Global Strategic Marketing (GSM), Health Economics and Market Access (HEMA), and Clinical Affairs (CA). Associate Medical Director , under limited ... apply. We are searching for the best talent for ** Associate Medical Director , Cardiac Imaging.** **Role Purpose**...Clinical experience with medical devices and knowledge of clinical trial design, evidence generation, adverse event… more