- 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...with internal and external stakeholders. + Possesses experience with clinical blinding practices in global study… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Senior Manager, Global Clinical Supply Chain KEY RESPONSIBILITIES: ... Senior Manager, Global Clinical Supply Chain is a leader...IVRS and ERP + systems. + Working knowledge of clinical study designs, blinding practices, global… more
- BeiGene (San Mateo, CA)
- …+ Lead and manage the Global Clinical Program Lead (GCPL)/ Global Clinical Study Manager (gCSM) group in designated Franchise(s)- therapeutic area ... efficient study planning and execution of associated clinical programs/ studies + Conduct regular program review...and lead efforts to deepen scientific knowledge within the Clinical Operations' function + Champions a global … more
- BeiGene (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
- BeiGene (San Mateo, CA)
- …regular updates on study progress in the region to senior management and Global Clinical Study Manager as required. + Oversees the regional study ... resolution of issues within the region for the assigned study or portfolio of studies . + Contributes...Clinical Study Report in collaboration with Global Clinical Study Manager and… more
- BeiGene (San Mateo, CA)
- …and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing. **Quality** _Line management ... regular updates on portfolio progress in the region to senior management and Global Study ...+ Oversees the planning and management of the assigned clinical studies from feasibility through closeout activities… more
- BeiGene (San Mateo, CA)
- The Associate Director (AD) Clinical Study Management leads both indirect and direct reports, external partners, consultants, vendors and external budget to ... of the study synopsis, protocol, case report and informed consent forms, clinical study reports and investigator brochure. Leads or co-lead aspects of a… more
- Astellas Pharma (South San Francisco, CA)
- …biologics concepts and methodologies, in particular as they relate to nonclinical study design and data analysis Experience drafting non- clinical sections of ... website: www.astellasgenetherapies.com. **The Role** The primary purpose of the Nonclinical Study Manager is to select Contract Research Organizations (CROs) and… more
- Pfizer (South San Francisco, CA)
- …of efficacy (ESOE) and proof of concept (POC) studies . + *The OES Clinical Scientist ( Senior Manager) will also be mentored/obtain guidance from a more ... Manger, non-MD) is to work collaboratively with the Global Development Lead (and members of the development team)... study clinician. Depending on experience, the OESD Senior Manager, Clinical Scientist may lead the… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Clinical Research Associates, Clinical Data Managers and other Clinical , Global Drug Safety, Regulatory and Project Management staff to meet ... aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Manager, Biostatistics - Virology** United States - **REMOTE** or Foster… more
- BeiGene (San Mateo, CA)
- …clear potential to apply their existing skills to oncology + Expert understanding of global clinical study design and drug development process from discovery ... 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
- BeiGene (San Mateo, CA)
- …clear potential to apply their existing skills to oncology + Expert understanding of global clinical study design and drug development process from discovery ... 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
- BeiGene (San Mateo, CA)
- …synopses, protocols, and amendments + Informed consent documents + Investigator Brochures + Clinical study reports + Abstracts, posters and manuscripts + ... functional areas for the successful implementation and execution of clinical studies + Provide scientific expertise for...trial data both internally and externally + Represent a clinical study or development program on one… 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 HIV prevention, and ... patients with life-threatening diseases. We are seeking a talented Senior Director of Phase 4 Research in HIV prevention...Phase 4 Research in HIV prevention to join our Global Medical Affairs team to help develop and lead… more
- Gilead Sciences, Inc. (Foster City, CA)
- …skills in a fast-paced, global company **FOCUSE AREAS:** + Interprets clinical study protocols and/or dosing schema. Translates the information to IMP ... strategies, IVRS and ERP systems. + Working knowledge of clinical study designs, blinding practices, global...Experience with managing comparator drugs and other co-meds for clinical studies . + Ability to collaborate, influence… more
- BeiGene (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
- BeiGene (San Mateo, CA)
- …Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core team etc.; combines ... study teams and programs to accelerate study execution. + Partners with global clinical program leaders and development core team on study design… more
- Frontier Medicines (South San Francisco, CA)
- …managing the timelines, supporting the clinical strategy for one or more clinical programs + Provide program and study -level direction to the strategic ... to Frontier Medicines' success and will be interacting with senior leaders, including the CEO, routinely. This is an...minimum 5 yrs Oncology development experience + Expertise in global regulatory and compliance requirements for clinical … more
- Abbott (Menlo Park, CA)
- …and providing device and management solutions for treating structural heart disease. As the Senior Clinical Engineer, you'll have the chance to define user needs ... Abbott is a global healthcare leader that helps people live more...to on-time, high quality completion. + Investigates and defines clinical requirements for new product/feature development and facilitates the… more
- Pfizer (South San Francisco, CA)
- …and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation ... is to lead and coordinate the development of multiple studies for novel biological and small molecule therapies for...of clinical study results + Supports execution for… more