- Crinetics Pharmaceuticals, Inc. (San Diego, CA)
- …ICH GCP, GDocP, CDISC TMF Reference Model (formerly DIA TMF Reference Model), and global clinical trial regulations.* Support with audits and regulatory ... belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make...training, and implementation.* Strong knowledge of ICH GCP, GDocP, global clinical trial regulations, and… more
- Crinetics Pharmaceuticals, Inc. (San Diego, CA)
- …Summary:**The Senior Director, Clinical Trial Supplies, is an end-to end clinical supply planning leader that provides relevant expertise in a fast paced ... Senior Director, Clinical Trial Supplies page is loaded##...have strong, cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company. The… more
- Stryker Group (Fremont, CA)
- …Director to lead the PMO function, focusing on shaping and implementing the global clinical strategy. The role involves managing a team of project managers ... and collaborating with divisional leaders to ensure clinical trial success. The ideal candidate will have over 10 years of experience in project management… more
- Summit Therapeutics Sub, Inc. (Menlo Park, CA)
- …(NSCLC), with three active Phase III trials: HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared ... Senior Director, Regulatory Affairs - Global Regulatory Leader About Summit: Ivonescimab,...EGFR TKI (eg, osimertinib). HARMONi‑3 is a Phase III clinical trial which is designed to evaluate… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to provide insight and input throughout the drug development process including clinical trial design, clinical endpoints, lifecycle management, and ... VP, Global Commercial Product Strategy, Oncology TA Lead...deals. Demonstrate strong people leadership aligned with Gilead's People Leader Accountabilities, and lead by example, respecting… more
- Stryker Group (Fremont, CA)
- …the Clinical discipline focused on, 1. Shaping and Implementing the global clinical strategy/portfolio in alignment with our product and portfolio strategy ... organizations to help shape and implement an overall integrated global clinical strategy/study portfolio for the entire...consultants, etc. as appropriate to ensure safe and successful clinical trial conduct. Meets with KOLs, study… more
- Neurocrine Biosciences (San Diego, CA)
- …properly* Supports investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory ... the evaluation, selection, compliance audit strategy, and oversight of global clinical investigators, contract clinical ...of experience as noted above* In-depth knowledge of all Clinical Trial related FDA regulations, ICH Guidelines,… more
- Revolution Medicines (Redwood City, CA)
- …expanded access programs, evidence generation, publications). Proven track record of clinical trial support including protocol development/review, site selection ... signaling pathway. The Opportunity: Reporting to the Lung Cancer Medical Affairs Strategy Lead , the Senior Director, Global Medical Affairs, will be responsible… more
- GRAIL (Menlo Park, CA)
- …and healthcare companies. For more information, please visit grail.com. The Senior Clinical Data Manager (CDM) will lead data management activities for ... 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 overcome… more
- SupportFinity (TM) (San Diego, CA)
- …solutions, including CDx co-development, clinical trial support, and global testing programs. Negotiation & Deal Execution Lead the full deal ... - Improving Lives with Precision Diagnostics(R) Invivoscribe is an industry pioneer and global leader in precision oncology diagnostics. For more than 30 years,… more
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