- Gilead Sciences, Inc. (Foster City, CA)
- …operates in more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director, Global Clinical Supply Chain** Senior ... practices and experience working with a GxP environment. The Senior Director, Global Clinical Supply...with internal and external stakeholders. + Possesses experience with clinical blinding practices in global study… more
- BeOne Medicines (San Mateo, CA)
- …of clinical study processes + Able to independently lead large and/or complex global clinical studies + 7 or more years of progressive experience in ... timelines and budget + Leads all aspects of assigned clinical study (ies) + Leads global ...endorsement by senior management + Adheres to clinical study budgeting processes and provides input… more
- BeOne Medicines (San Mateo, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study ... and budget + Acts as regional lead for multiple studies across an indication or across a program as...Clinical Study Report in collaboration with Global Clinical Study Manager and… more
- BeOne Medicines (San Mateo, CA)
- …and resolution of GMP and GDP compliance matters. This role reports to the Senior Director, Global Clinical Operations Compliance Lead. **Essential Functions ... **General Description:** The Director Global Clinical Supply Compliance builds, collaborates...and implementation of risk identification and management strategy for clinical studies and other regulated drug development… 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
- Danaher Corporation (Sunnyvale, CA)
- …have oversight for clinical strategy, protocol development and clinical study reports for US and OUS registration studies + Prepares scientific content ... Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Clinical Research Scientist reporting to the… more
- BeOne Medicines (San Mateo, CA)
- …a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance ... with ICH-GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical … more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is seeking a Senior Scientist, Global Market Protection for a contract opportunity with a leading molecular diagnostics company ... Experiments, statistical tools, interpretation and reporting of results for analytical and clinical studies . + Experience with technical writing. **Why Join… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Senior Clinical Scientist is involved in the design, monitoring, and data analysis ... growth hormone, parathyroid hormone, and/or C-type natriuretic peptide therapies. As such, the Senior Clinical Scientist is an important and visible member of… more
- Taiho Oncology (Pleasanton, CA)
- …NDA/MAA registration documents, and scientific publications. + Analyze and interpret outcome of clinical studies within the global development program(s) + ... it most. This is an exciting opportunity to lead global clinical trials and experience multiple facets...+ Use medical/scientific expertise and strategic thinking to develop clinical development plans (incl. study design and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** Gilead's Director, Global Clinical Supply Chain is an end-to-end clinical ... Senior Director works internally with other members of Global Supply Chain (GSC) and other Gilead functions -...+ Often in a matrix environment, oversees and supports clinical study planners. Facilitates issue and risk… more
- BeOne Medicines (San Mateo, CA)
- …Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core team etc.; combines ... studies , for early to late-stage medicines development across global clinical operations (GCO). Good understanding of...to accelerate study execution. + Partners with global clinical program leaders and development core… more
- Abbott (Santa Clara, CA)
- … specialists, project management, biostatistics, medical affairs, data management, and other clinical study personnel towards clinical evidence generation, ... strategy development, oversight of trial execution, and generation of clinical study reports/ scientific publications from data...Be responsible and accountable for planning and executing the global clinical evidence generation plans + Set… more
- Ascendis Pharma (Palo Alto, CA)
- …Programming, will be expected to provide timely and strategic programming support to clinical study teams in alignment with project goals. This role combines ... and specification templates of SDTM and ADaM used across clinical studies . This position requires expertise in...Generate or validate tables, listings, and figures (TLFs) for clinical study reports, ISS/ISE, and regulatory submissions.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with the clinical development plans and overarching asset strategy, serve as Gilead study lead for key interventional Phase 4 studies in LIVE, and help to ... patients with life-threatening diseases. We are seeking a talented Senior Director of Phase 4 Research in Liver, Inflammation,...Respiratory Viruses, and Established Products (LIVE) to join our Global Medical Affairs team to help develop and lead… more
- Taiho Oncology (Pleasanton, CA)
- …to support the creation of relevant high-quality clinical documents such as study protocols and clinical study reports (CSRs), investigator brochures, ... conferences and leverages the knowledge for designing and summarizing clinical studies . + Keeps Sr. Medical Director...as reviewing of the quality of ongoing and final clinical study data, protocols and CSRs, investigator… more
- BeOne Medicines (San Mateo, CA)
- …and present data to internal project teams, senior management, and to global health authorities. + Discuss clinical pharmacology & pharmacometric plans to ... all phases of clinical development. + Develop clinical pharmacology study designs and collaborate with...the design and analysis of PK data from patient clinical studies . + Conduct hands-on clinical… more
- Abbott (Santa Clara, CA)
- …Work On** + Writes clinical trial protocols, protocol amendments, clinical study reports, and scientific publications. by evaluating scientific literature, ... in more than 160 countries. **Job Title** **Sr. Scientist Clinical Research** **About Abbott** Abbott is a global...study support groups cross-functional teams to assist in clinical strategy, the development of plans, reports and project… more
- Gilead Sciences, Inc. (Foster City, CA)
- …professional, who will develop, implement, and manage the strategic publication plans for global clinical studies and non- clinical sources, including ... HEOR, Epidemiology, RWE, Payer, Non-interventional, and database studies , to demonstrate the value of pipeline and inline products in HIV. This position is located… more
- Gilead Sciences, Inc. (Foster City, CA)
- …methodological advances and trends to ensure best approaches are used in relevant studies and evaluations. + Engage key clinical , methodologic, and TA experts ... Respiratory Viruses, and Established Products (LIVE) to join our Global Medical Affairs team. This role is responsible for...LIVE including leading and supporting Gilead Sponsored and Collaborative studies , and serving as the Team Lead for the… more