- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** ... **RESPONSIBILITIES** The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of scientists, who collaborate with product… more
- Merck (South San Francisco, CA)
- …initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + ... **Job Description** The ** Senior Clinical Director (Sr....closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , Global Clinical Supply Chain - Inflammation/MAP** **KEY ... RESPONSIBILITIES:** Senior Director , Global Clinical Supply Chain is an... Operations, Product Development & Manufacturing (PDM), Quality Assurance, Regulatory , and Project Management Office - to develop and… more
- Frontier Medicines (South San Francisco, CA)
- …Medicines is seeking a highly motivated individual to fill the position of Sr. Director Clinical Operations to help develop the early project portfolio. The team ... The position will report to the CMO. The Sr. Director Clinical Operations will be a key...5 yrs Oncology development experience + Expertise in global regulatory and compliance requirements for clinical development,… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical ... with BeiGene functional leadership (including but not limited to clinical Operation, Quality, Regulatory , CMC, and GRDS) to ensure alignment of organizations and… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists **_THE OPPORTUNITY_** This Senior Medical and Clinical Director position works out of ... and publication. * Responsible for aspects of medical and clinical team contributions to regulatory strategy, ...of medical and clinical team contributions to regulatory strategy, regulatory filings, quality management system… more
- BeiGene (San Mateo, CA)
- The Senior Director , Clinical Development, Solid Tumors will support BeiGene Clinical and Medical assets by successful execution of clinical ... colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory , molecular diagnostics, and… more
- BeiGene (San Mateo, CA)
- …GCO Franchise Head is accountable for the strategic operational planning and clinical operational performance to deliver in the Franchise(s)- therapeutic area(s) or ... in the Franchise(s) + Lead and manage the Global Clinical Program Lead (GCPL)/ Global Clinical Study...a deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements + Point of escalation for all program… more
- Ascendis Pharma (Palo Alto, CA)
- …and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation ... employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for...reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to… more
- BeiGene (San Mateo, CA)
- The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory strategies for ... direction and leadership on projects including, but not limited to, global regulatory strategies, regulatory requirements for clinical studies and marketing… more
- BeiGene (San Mateo, CA)
- …direction and leadership on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and ... **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… more
- BeiGene (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory ... direction and leadership on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing… more
- BeiGene (San Mateo, CA)
- …direction and leadership on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and ... The Executive Director , Solid Tumor North America Lead will be...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… more
- Stryker (Fremont, CA)
- …benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Global ... and managing all clinical individuals responsible for generation of clinical study reports, regulatory -required routine reports, publications, podium … more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Senior Director , Medical Writing Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... for patients suffering from immunological diseases. Position Summary: The Senior Director , Medical Writing will report to...all of Vera's drug development programs, producing high quality regulatory and clinical documents that meet … more
- BeiGene (San Mateo, CA)
- **General Description:** The Director , Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology and ... and working in close partnership with other key functions such as Clinical Development, Biometrics, Biomarkers, Regulatory , CMC etc. Responsibilities will… more
- Vera Therapeutics (Brisbane, CA)
- …experienced, fast-paced and collaborative team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for ... programs. The Senior Manager will support both CMC and Clinical Regulatory activities. Responsibilities: * Proactively manage Clinical and CMC aspects… more
- BeiGene (San Mateo, CA)
- …and with external academicians and collaboration partners. The candidate will report to the Senior Director , Clinical Development. As a leader in the ... **General Description:** The Director , Clinical Science will support BeiGene...colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory , molecular diagnostics, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and ... + Extensive experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations. + Multiple years' line… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Medical Director , Hematology will support BeiGene Clinical and Medical Hematology assets by successful execution of ... colleagues in clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance, regulatory , molecular diagnostics, and… more