- Gilead Sciences, Inc. (Foster City, CA)
- …are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical ... + Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products. + Provides… more
- Gilead Sciences, Inc. (Foster City, CA)
- …monitoring, including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality ... part of a cross-functional team + Lead the development of the target product profile and clinical development plan for assigned molecules /products considering both… more
- J&J Family of Companies (Irvine, CA)
- …(eg study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports); + Ensures applicable trial registration (eg on ... + Oversees and supports the development and execution of Investigator agreements and trial payments. + Is responsible for...May serve as the clinical representative on a New Product Development team. + May assist with the development… more
- Parexel (Sacramento, CA)
- …various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate risks. **Key ... etc.) + Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country...of monitoring + Supports the CRA to develop positive Investigator relationships throughout the life of the study and… more
- J&J Family of Companies (Irvine, CA)
- …study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports), ensure registration on www.clinicaltrials.gov from ... and company personnel; + Supervise the development and execution of Investigator agreements and trial payments; + Responsible for clinical data review… more
- Lilly (San Diego, CA)
- …clinical trials in support of registration and commercialization of the product ; the implementation of global clinical trials; the reporting of adverse ... events as mandated by corporate patient safety ; the review process for protocols, study reports, publications and data dissemination for products, new and updated… more
- BeOne Medicines (San Mateo, CA)
- …development, program leadership, clinical operations, legal, compliance, new product planning, clinical business development intelligence, safety ... clinically relevant regional medical meetings (eg, advisory boards, consultant, and investigator meetings), as requested + Build strong relationships with internal… more
- Pfizer (South San Francisco, CA)
- …and regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk ... clinical trial data. + Review and approve submission level safety narrative plan. + Supports product label...submission level safety narrative plan. + Supports product label development and maintenance. + Engage key external… more
- Amgen (Thousand Oaks, CA)
- …The position will work closely with all members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, ... as well as the overall product strategy. The Executive Director will report into the...of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis… more
- J&J Family of Companies (Irvine, CA)
- …clinical operations teams by providing critical medical and scientific input to ensure product safety and efficacy. + Works with cross-functional partners in ... towards development and approval of clinical trial protocols, informed consents, investigator brochures, committee charters, and other study materials. + Conduct… more