- Bristol Myers Squibb (San Diego, CA)
- …on protocols/SAP + Participate in reviewing, analyzing, and reporting clinical trial data and generating outputs to support DSUR/IBs, publications, FDA ... ongoing studies + Oversee CDISC data package development for clinical studies to support CSRs and future...Knowledge with FDA and ICH regulations and guidelines, and clinical trial methodologies. + Good written and… more
- Bristol Myers Squibb (San Diego, CA)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Director , Medical Affairs Research Operations, plays an integral role in supporting the ... Medical Affairs team. This position provides operational and scientific support of investigator-initiated trials, to ensure their successful implementation. This… more
- BeOne Medicines (San Carlos, CA)
- …predictive models and scenario analysis frameworks to assess asset progression probability, clinical trial outcomes, and market access feasibility. + Utilize ... optimizing patient segmentation and treatment pathways. + Strong understanding of clinical trial design, regulatory pathways, and market access considerations.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …readiness to enable successful manufacturing execution. + Possess basic understanding of clinical trial design and its ramifications for IMP demand planning. ... + Support PDM Operations Management's product portfolio reporting & analytics + Support and manage Director -level PM's work on non-product projects + Lead,… more
- BeOne Medicines (San Mateo, CA)
- …etc.) in collaboration with Safety Science team members and relevant cross-functional team members ** Clinical Trial Support ** + Lead the review of safety ... **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction...RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members + Support … more
- J&J Family of Companies (Irvine, CA)
- …Learn more at https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Support **Job Category:** People Leader **All ... Director will lead the strategy and execution of Clinical Evaluations (CERs), State of the Art Assessments (SOA),...the Eudamed Readiness strategies for SSCP and PSURs in support of the EU MDR. **Responsibilities:** + Lead a… more
- Vera Therapeutics (Brisbane, CA)
- …agreements, IT/software licensing, data privacy agreements, service agreements, clinical trial agreements, confidentiality agreements, consulting agreements, ... Title: Senior Director , Senior Corporate Counsel Location: Brisbane, CA About...About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical -stage biotechnology company focused on developing treatments for serious… more
- BeOne Medicines (Emeryville, CA)
- …Lead signal assessment documentation following BeiGene signal management and safety governance framework. Clinical Trial Support + Lead the review of safety ... in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the detection of...depending on the program / portfolio being led. The Director , Safety Scientist provides key support as… more
- Edwards Lifesciences (Irvine, CA)
- …evidence generation strategies using RWD (eg, claims, EMR, administrative data, adaptive clinical trial designs). + Proven track record in leading teams ... ** Director , GHER TMTT Real World Evidence** Innovation starts...overcome market access barriers, and drive impactful evidence for clinical , regulatory, and commercial success. This role also includes… more
- Gilead Sciences, Inc. (Foster City, CA)
- …area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes. + Strong preference ... Gilead and help create possible, together. **Job Description** **Senior Director , RWE Virology Safety Epidemiology Lead** **Position Description** The Real-World… more