- Ascendis Pharma (Palo Alto, CA)
- …and regulatory submissions + Maintain up-to-date knowledge of relevant science , medical information, good clinical practices, and regulatory guidance + ... Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science , visionary leadership, and skilled and passionate colleagues. Guided by our core… more
- Kelly Services (Thousand Oaks, CA)
- …of the latest scientific advances in CNS drug delivery, bioanalysis, and regulatory frameworks to ensure research practices are aligned with industry standards. ... **Qualifications & Skills:** + **Education:** PhD in a life sciences field (eg, Neuroscience, Pharmacology,...member of the Kelly Talent Community. Why Kelly (R) Science & Clinical? Kelly Science & Clinical… more
- Merck (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses + Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory … more
- Medtronic (Irvine, CA)
- …specifications and directions to the clinicians/statistical programmers. + Supports the regulatory review and approval of the experimental therapies. + Partner in ... in responding to relevant questions from FDA, FDA Advisory Panels, and/or other regulatory agencies, and in negotiations with regulatory agencies regarding study… more
- Bristol Myers Squibb (San Diego, CA)
- …will work cross-functionally with several departments (Clinical Operations, CMC, Regulatory Affairs, Supply Chain, Drug Safety/PV, Compliance and Legal). ... area oversight to ensure quality of work and appropriate compliance with regulatory requirements + Conduct budget negotiations for Medical Affairs IITs, including… more
- AbbVie (Irvine, CA)
- …innovation in aesthetics, we're committed to providing the most comprehensive science -based product offerings available. The Director II, Clinical Development will ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …a broad understanding of IVD and laboratory developed test (LDT) regulatory environment. By interacting with clinical researchers, laboratory leaders and industry ... ensure effective and compliant clinical products and clinical trials to support regulatory and commercial goals + Develop strategic relationships with key customers… more
- Bristol Myers Squibb (San Diego, CA)
- …. The **Clinical Scientist Program Lead** reports through the Clinical Science function which provides scientific expertise necessary to design and deliver ... of innovative protocols and data packages for CSRs and Regulatory Filings. The Program Lead oversees all clinical studies...program(s). * Serves as a member of the Clinical Science Leadership Team and Global Program Team * Drives… more
- Bristol Myers Squibb (Brisbane, CA)
- …we are inspired by a single vision - transforming patients' lives through science . In oncology, hematology, cell therapy, immunology and cardiovascular disease - and ... institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. Provides guidance and… more
- Gilead Sciences, Inc. (Foster City, CA)
- … science or related fields, or 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such ... + Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting Gilead's global logistics… more