- Merck & Co. (South San Francisco, CA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of...drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide clinical … more
- Merck & Co. (South San Francisco, CA)
- …and medical monitoring of clinical studies .Supervises development of clinical documents including protocols, clinical study reports and background ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus...of assets within the pediatric section of the Vaccine Clinical Development TA.May serve as a senior … more
- Novo Nordisk Inc. (San Mateo, CA)
- …NNI and competitor products Demonstrates thorough knowledge of all promoted NNI approved clinical studies and the skill to engage customers (prescribers, support ... offer the chance to be part of a truly global workplace, where passion and engagement are met with...access and drive business impact by collaborating around the clinical management of patients and offering NNI-approved solutions Demonstrates… more
- 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
- 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
- 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
- Merck (South San Francisco, CA)
- …medical monitoring of clinical studies . + Supervises development of clinical documents including protocols, clinical study reports and background ... **Job Description** The Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus...Clinical Development TA. + May serve as a senior therapeutic area content expert within the company, providing… 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
- Abbott (Alameda, CA)
- …. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality ... will do:** + Conduct single or multi-center medical device clinical studies . + Perform study ...procedures and applicable regulatory requirements. + Responsible for assisting senior staff in planning study conduct, designing… 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
- Abbott (Alameda, CA)
- …shipping study devices and supplies to clinical sites. + Perform study device accountability and reconciliation. + Assist senior staff in development of ... study -specific forms and trial-specific monitoring plans. + Assist senior staff in study planning, designing case...needed. + Proactively and effectively communicate the status of clinical studies to management. + Participate in… more
- Bristol Myers Squibb (Brisbane, CA)
- … lifecycle. ** Clinical Development Expertise & Strategy** + Designs and develops clinical studies and research plans in support of asset strategy with the ... Early Clinical Development Leadership team; Clinical ...initiatives (eg, committees, sub-teams etc.) + Presents and/or articulates clinical strategy to senior leadership and to… 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
- Merck (South San Francisco, CA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of...drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) + Provide … 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
