- BeOne Medicines (San Mateo, CA)
- …in collaboration with Safety Science team members and relevant cross-functional team members ** Clinical Trial Support** + Lead the review of safety data and ... monitor the safety of patients on allocated clinical trials + Lead the writing and...effective execution, communication and influence with internal stakeholders (eg, clinical development, medical , regulatory, labeling) and external… more
- Bristol Myers Squibb (San Diego, CA)
- …outputs based on protocols/SAP + Participate in reviewing, analyzing, and reporting clinical trial data and generating outputs to support DSUR/IBs, publications, ... Knowledge with FDA and ICH regulations and guidelines, and clinical trial methodologies. + Good written and...perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of… more
- J&J Family of Companies (Irvine, CA)
- …and is as challenging as it is rewarding. The Director will have medical affairs responsibility in providing therapeutic and clinical expertise in support of ... and post-marketing support + Provide scientific expertise, oversight and approval for clinical trial concept, design, analysis and reporting of clinical… more
- Ascendis Pharma (Palo Alto, CA)
- …in the design, monitoring, and data analysis of the Company's late-phase clinical trials studying growth hormone, parathyroid hormone, and/or C-type natriuretic ... consider a remote arrangement for the right candidate. Key Responsibilities + For clinical trials : design, provide oversight, and support site and subject… more
- Merck (South San Francisco, CA)
- …+ Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... all phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. + Represent QP2 on cardiometabolic… more
- Gilead Sciences, Inc. (Foster City, CA)
- …fully cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of ... Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care...regulations, ICH guidelines and GCPs governing the conduct of clinical trials + Scientific knowledge/ experience in… more
- Pfizer (Sacramento, CA)
- …Development (GPD) in the identification of potential sites for Pfizer-sponsored clinical trials , including identification of sites serving under-represented ... patient populations in trials + Appropriately provide Medical support throughout...(GI) cancer, Melanoma, or Gynecological cancer + Familiarity with Clinical trials Candidate demonstrates a breadth of… more
- Amgen (South San Francisco, CA)
- …assets, guiding them from Discovery through IND-enabling studies and into first-in-human (FIH) clinical trials . As a key translational thought leader, you will ... datasets; and (4) Development and testing of patient-selection hypotheses in FIH trials . In collaboration with clinical teams, you will also establish… more
- Bristol Myers Squibb (Brisbane, CA)
- …DSURs, etc. + Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments ... and unique perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of passion, innovation, urgency,… more
- ThermoFisher Scientific (West Sacramento, CA)
- …members. This position is crucial for maintaining the high standards of our clinical trials and ensuring accurate and reliable results. **Key Responsibilities:** ... bench work, including the preparation, processing, and analysis of clinical trial samples. + Quality Control: Coordinate...operation of the lab and the successful completion of clinical trials . + Continuous Improvement: Engage in… more