- BeOne Medicines (San Mateo, CA)
- …study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... quality, within agreed timelines and budget + Acts as regional lead for multiple studies across an...meetings and at the cross-functional Clinical Study Team (CST) meetings + Leads regional … more
- BeOne Medicines (San Mateo, CA)
- …functionally. Understands Annex 13 and PSF. + Works collaboratively with global and regional study teams to ensure that proper root cause assessments, corrective ... and implementation of risk identification and management strategy for clinical studies and other regulated drug development...processes, procedures, regulations and tools intended for use in clinical study conduct and other regulated drug… more
- BeOne Medicines (San Mateo, CA)
- …and study levels + Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core ... , for early to late-stage medicines development across global clinical operations (GCO). Good understanding of global, regional...across study teams and programs to accelerate study execution. + Partners with global clinical … more
- Stanford Health Care (Palo Alto, CA)
- …of clinical results as appropriate; and present at local, regional and national research meetings/conferences as appropriate. + Reports on activities and ... which serves patients across the world. Its robust network of seven clinical sites staffed by Stanford's team of renowned surgical oncologists, medical oncologists,… 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 ... LIVE including leading and supporting Gilead Sponsored and Collaborative studies , and serving as the Team Lead for the...(ET). The ideal candidate will have previous experience in clinical and operational research, and significant knowledge in one… 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 ... are met including the review global submission documents in support of clinical trials and marketing applications, and their amendments to support investigational… more
- BeOne Medicines (San Mateo, CA)
- …but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory ... the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to...the US and Canada. + Supports the NA hematology regional team to negotiate with the US FDA as… more