- Abbott (Santa Clara, CA)
- …for clinical research and operational excellence? Join our high-impact team as a Senior Director , Clinical Study Management overseeing a global ... portfolio of 100+ clinical studies across six business units in our Medical Devices...clinical trials with budgets exceeding $100MM. + Influence study design allowing for seamless study execution.… more
- BeOne Medicines (San Mateo, CA)
- …ensure feasibility, study start-up, site management, drug supply and other clinical studies ' activities operating according to GCP and Health Authorities' ... for the planning, budget, and oversight the execution of clinical studies of BTU assets, through partnering...efficient study planning and execution of associated clinical programs/ studies + Conduct regular review meetings… more
- BeOne Medicines (San Mateo, CA)
- …plan for end-to-end clinical trial processes owned by Global Clinical Operations. This includes monitoring, study management, identifying areas for ... **General Description:** **The Head of Global Clinical Process Management is responsible for designing, implementing,...cross functionally. You will partner with all functions across Clinical Development and Global Process Owners (GPOs) to shape… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Data (RWD) to help transform innovations to life-changing medicines for patients. The Senior Director , RWE Inflammation Product Lead reports to the Executive ... Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical...and use of RWE at the global level. The Senior Director , RWE Product Lead will oversee… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Kite and help create more tomorrows. **Job Description** The US Medical Senior Director , MA Evidence Generation at Kite Pharma, a Gilead Company, ... studies , and US Strategic Alliances. + Lead the development of clinical study concepts, protocols in collaboration with Medical and Clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** ... operating within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director , Product Management Team Lead** will lead a… more
- BeOne Medicines (San Mateo, CA)
- …development and establish geographic footprints and proposed sites for participation in clinical studies . + Consider the unique needs of each indication, ... and enrollment challenges. + Participate in regional and global projects, representing Clinical Operations and Study Optimization to support BeiGene R&D goals.… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** Reporting to the Head/ Director of Clinical Trial Diversity, the Associate Director will operationalize BeOne's clinical trial ... Operations, Regulatory, Development, and corporate functions to embed diversity into study design and site selection. The Associate Director will build… more
- Stryker (Fremont, CA)
- …constituents on a routine basis as deemed appropriate to gather information on clinical study performance, strategy, and voice of customer. + Co-leads and ... and regional organizations to help shape and implement an overall integrated global clinical strategy/ study portfolio for the entire NV business. + Presents … more
- Gilead Sciences, Inc. (Foster City, CA)
- …capabilities to support the CDS objectives + Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure ... clinical trials are conducted in compliance with Gilead procedures,...practices and methods + Work closely with Gilead CDS study team to provide expert advice on compliance issues… more
- GRAIL (Menlo Park, CA)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies , and state-of-the-art computer science and data science to ... companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead...management activities for one or multiple diagnostic product development studies in support of GRAIL's robust clinical … more
- BeOne Medicines (San Mateo, CA)
- …timely, quality, and efficient study planning and execution of associated clinical programs/ studies + Conduct regular program review meetings to mentor, ... the Global Clinical Program Lead (GCPL)/ Global Clinical Study Manager (gCSM) group in designated...operations insights and expertise at franchise level. The Executive Director may act as a leading representative and spokesperson… more
- Gilead Sciences, Inc. (Foster City, CA)
- …at Gilead Sciences is seeking a highly experienced candidate for the position of Senior Director of DMPK with the primary responsibility of providing expert PK ... evaluation and contribute to regulatory filings. **Job Title: Senior Director , Drug Metabolism and Pharmacokinetics (DMPK)**...to the design of nonclinical PK, toxicology, or pharmacology studies . + Prepare study protocols and coordinate… more
- BeOne Medicines (San Mateo, CA)
- …will provide strategic statistical leadership for pharmacokinetic (PK) and pharmacodynamic (PD) studies across all phases of clinical development. This role ... with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs, and Clinical Development to ensure robust study design, insightful data analysis, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** R&D Quality is seeking a Senior Director , Quality Operations Excellence Lead to join our R&D Program ... consistent performance and outputs of key activities such as study oversight plans, critical quality event management, serious breach...area analytics and Quality Briefs. Reporting to the Executive Director , R&D Program Quality, you will also be a… more
- Stanford University (Stanford, CA)
- …comprehensive learning and professional development strategy for research administration across grants, clinical research, and clinical studies . + Design and ... Director , Training, Development & Outreach **School of Medicine,...skilled, and future-ready research administration workforce spanning grants administration, clinical research, and clinical trials. The ideal… more
- Gilead Sciences, Inc. (Foster City, CA)
- …portfolio (currently Oncology and Virology). This position will report to the Senior Director , Portfolio Strategy. **Job Responsibilities (including, but are not ... an exciting opportunity within US Medical Affairs for a Director , Portfolio Strategy in our Patient Access and Quality...Co-ordinate the US Local Review Committee (LRC) - prepare study teams to come to LRC with appropriate, in… more
- BeOne Medicines (San Mateo, CA)
- …including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for...including the review global submission documents in support of clinical trials and marketing applications, and their amendments to… more
- BeOne Medicines (San Mateo, CA)
- …but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans ... **General Description:** The Director , Regulatory Affairs will be responsible for developing,...utilized in the US and Canada in support of clinical trials and marketing applications, and their amendments in… more
- GRAIL (Menlo Park, CA)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies , and state-of-the-art computer science and data science to ... manage and provide direction to regulatory staff and, when required, participate in senior management meetings as a delegate. The role fosters a work culture aligned… more