- Ascendis Pharma (Palo Alto, CA)
- …with other project team members and regulatory colleagues. + Contributes to the development of global clinical regulatory plans and strategies, identifies, ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe,...Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global clinical or commercial submissions. In addition, you will be ... process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development . + Responsible for development of regulatory… more
- Merck (Sacramento, CA)
- …in alignment with Global Clinical Trial Operations (GCTO) and the broader Global Clinical Development (GCD) + Coordinates with Global Medical ... **Job Description** The Executive Director (ED) for US Medical Affairs (USMA) understands...Company's enterprise level strategies and leads cross-functionally with the Global Medical and Scientific Affairs Therapeutic Area (GMSA TA)… more
- Edwards Lifesciences (Irvine, CA)
- ** Director , GHER TMTT Real World Evidence** Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, ... and discovering lasting solutions for unmet patient needs. Our Director , GHER TMTT Real World Evidence position is a...future. This is a compelling opportunity to join the Global Health Economics & Reimbursement (GHER) team at Edwards… more
- Oura (San Francisco, CA)
- …and guide teams on risk-based approaches to regulatory compliance in product development , clinical validation, and market positioning. + Oversee compliance with ... wellness claims. + Provide legal and regulatory oversight for clinical studies and evidence generation, including IRB approvals, informed...adherence across the organization. + Partner with the Sr. Director - Global Risk & Asset Protection… more
- Moses/Weitzman Health System (CA)
- …MWHS experts in development and philanthropy along with experts in clinical , programmatic, operational and research domains. The Director , Grants leads ... **Job Description Summary:** **Job Description:** The Director , Grants leads the Pre and Post Grant...works closely with the MWHS' lead experts in strategic development in both the private and public sectors and… more
- Merck (Sacramento, CA)
- …Skills:** Advisory Board Development , Clinical Engagement, Clinical Trial Support, Gastrointestinal Cancer, Gastrointestinal Oncology, Global Medical ... enrollment and retention efforts to achieve study milestones + Upon request from Global Clinical Trial Operations (GCTO), + Recommends study sites and identifies… more
- Sumitomo Pharma (Sacramento, CA)
- … should identify and effectively communicate regarding overarching corporate strategies, clinical development programs, and commercial capabilities of key ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...business questions and relevant cross-functional stakeholders, including in Commercial, Clinical Development , Medical Affairs, Regulatory, Sales leadership… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- … development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a ... This individual will be an integral leader of process development for the viral vector programs at Kite with...workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …regulatory requirements. + Good working knowledge of formulation development , drug development and clinical development . + Current awareness of the ... Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people...limited to dose finding, dose optimization, exposure-response and pediatric development . You will Author clinical pharmacology and… more