- 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 + 8 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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …supports Clinical Project Manager to complete activities related to clinical studies for ethics review, regulatory submissions and site ... **Job Description Summary** Associate Clinical Project Manager / Senior CRA...is to support the execution and completion of assigned clinical research studies . The position will work… more
- Pfizer (South San Francisco, CA)
- **ROLE SUMMARY:** The Senior Manager, Oncology Early Stage Clinical Scientist will work collaboratively with the Global Development Lead (and members of the ... Early Stage Development (OESD) is represented as needed within clinical study teams. You will also be...You will also be mentored/obtain guidance from a more senior study clinician. Depending on experience, you… 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)
- …clear potential to apply their existing skills to oncology. + Expert understanding of global clinical study design and drug development process from ... amendments + Informed consent documents + Investigator Brochures + Clinical study reports + Abstracts, posters and...functional areas for the successful implementation and execution of clinical studies . + Provide scientific expertise for… 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 one-year contract opportunity with a leading molecular diagnostics ... Experiments, statistical tools, interpretation and reporting of results for analytical and clinical studies . + Experience with technical writing. **Why Join… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager, Global Regulatory Affairs, Precision Medicine, you will help ... and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs, global registration, and market access. This role will… more
- BeOne Medicines (San Mateo, CA)
- …responsible to implement the GCO digital strategy with the goal to increase Global Clinical Operations' productivity and reduce clinical trial ... **General Description:** The Senior Manager, Digital Clinical Operations Solutions...Manage the implementation of GCO technology roadmap to increase Global Clinical Operations' productivity, reduce rising costs… 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
- 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
- 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
- AbbVie (South San Francisco, CA)
- …Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Senior Manager works independently in partnership with ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, Statistics provides statistical leadership to support the research… more
- BeOne Medicines (San Mateo, CA)
- …Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with PSLs and other Clinical Study Team (CST) members . Support the authoring of ... **_General Description:_** The Senior Manager, Safety Scientist supports assigned compounds in...making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence… 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