- BeiGene (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
- BeiGene (San Mateo, CA)
- …financial goals + Works with the sourcing team to strategize on regional study vendor needs. + Works closely with Clinical Business Operation on optimizing ... leadership team, provides strategic leadership, management, and/or mentorship to clinical study managers at various levels for...regional lead (if needed) for one or multiple studies across an indication or across a program as… more
- BeiGene (San Mateo, CA)
- …study progress in the region to senior management and Global Clinical Study Manager as required. + Oversees the regional study team at internal ... for the assigned study or portfolio of studies . + Contributes to the development of regional...throughout the study life cycle. + As regional study lead, informs Global Clinical… more
- Stryker (Fremont, CA)
- …can include processes that relate to the generation of Clinical Study reports (SSR, IIR, Collaborative Studies , etc.) CER/CES, regulatory-required annual ... and managing all clinical individuals responsible for generation of clinical study reports, regulatory-required routine reports, publications, podium … more
- BeiGene (San Mateo, CA)
- …TA, indication, program levels + Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development ... delivery of 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
- Abbott (Santa Clara, CA)
- …support to CRM Sales Representatives in the following areas: + Sales support + Regional training seminars + Clinical studies /data collection + Trouble ... of all Clinical Specialists in the region. + Acts as a senior clinical interface between the medical community and the business. + Demonstrates ability to… 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 ... Nursing Professional (ORNP) -is a Registered Nurse (RN) who works collaboratively with Clinical Research Staff including, but not limited to Physicians, Clinical … more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development organization, which includes responsibility for medical safety aspects of clinical studies such as protocol design, benefit-risk assessment, signal ... and leverage their experience to represent Patient Safety in discussions with senior leadership and Executive Management. The GHPS oversees patient safety governance… more
- BeiGene (San Mateo, CA)
- …global strategy for a single asset across its entire life cycle - from clinical development to late-stage pivotal studies , then through commercial launch and ... risk to senior leadership. + Work collaboratively with global and regional commercial teams to generate, evaluate, and deliver robust commercial strategies and… more
- BeiGene (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...US and Canada. + Supports the NA solid tumor regional team to negotiate with the US FDA as… more
- BeiGene (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
- BeiGene (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
- Gilead Sciences, Inc. (Foster City, CA)
- …the world - Being Here Matters. We are seeking a bright and enthusiastic senior toxicologist to complement our Nonclinical Safety (ie Toxicology) group. Gilead is a ... multiple projects simultaneously with minimal supervision. + Reviews protocols, data and study reports ensuring presentation of data in report is accurate and… more