- 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
- Vera Therapeutics (Brisbane, CA)
- …Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory aspects of clinical studies in early-to-late development to create high quality ... Title: Senior Manager, Clinical Regulatory Location: Brisbane,...for submission, ensuring complete regulatory content that meets current regional requirements * Represent clinical Regulatory Affairs… more
- Medtronic (San Francisco, CA)
- …and therapies + Collaborates with clinical research organization relative to clinical studies and physician research + Commitment to personal continued ... therapies provide a competitive advantage. + Disseminate competitive information to regional teams + Delivers competitive technical and clinical training… more
- BeiGene (San Mateo, CA)
- …and support local adaptation for specific market needs. + Working together with commercial, clinical , medical / HEOR and regional market access teams, align on ... Solid Tumor portfolio of pipeline assets. This is a senior role that is critical in setting the foundation...will focus on identifying market access-related evidentiary gaps in clinical development plans that could result in a breadth… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Study applications, SRD & IDE applications, HA briefing books, clinical protocols, study reports, ICFs, Investigator Brochures, IND applications, CTAs, ... Join Gilead and help create possible, together. **Job Description** As an Senior Manager, Global Regulatory Affairs, Precision Medicine, you will help develop and… more
- Sutter Health (Emeryville, CA)
- …to population health as typically acquired during 5-7 years of experience in senior level clinical management Comprehensive knowledge of Centers for Medicare and ... related to care management resources, continuity of care, disease management, and clinical outcomes of all case management and social services in both inpatient… more
- BeiGene (San Mateo, CA)
- …+ Works cross-functionally to ensure proper planning of inclusive clinical study protocols, providing feasibility feedback on regional site selection and ... **General Description:** Reporting to the Head of Americas, Clinical Operations, the Director - Clinical ...to hold composure, be engaged and present adeptly to senior BeiGene leadership when needed + Scientific acumen -… more
- BeiGene (San Mateo, CA)
- …ensuring internal partnership across the organization. The candidate will report to the Senior Regional Director, Solid Tumor - GI, within Medical Affairs. As ... . The **Field Medical Director (FMD)** will support BeOne Medicines pre- clinical and clinical pipeline development by coordinating external collaborations,… 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)
- …including, but not limited to, global regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory ... affairs departmental and cross-functional influence and acts as an advisor/liaison to senior management and project teams to plan, evaluate and recommend regulatory… 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
- 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
- RELX INC (San Francisco, CA)
- …support the creation of commercial go-to-market (GTM) strategies together with regional GTM leads. Specifically, solutions targeted at the physician persona ... acumen with consultative selling abilities, excellent communication skills with senior leaders and customers. Paired with strategic thinking and outstanding… more
- ThermoFisher Scientific (San Francisco, CA)
- …Quality related programs and activities to support site operations for clinical and commercial manufacturing, testing, and release of biopharmaceutical products. ... of the Quality team, ensuring delivery of high-quality analytical stability studies , transfers, qualifications, and validations within set timelines. + Develop… more