• Arcellx (Redwood City, CA)
    …respect a diverse set of views and backgrounds. How You'll Make a Difference As our Senior Director , Clinical Regulatory Affairs, you'll lead and drive ... Arcellx's clinical regulatory approval strategy and implementation and oversee post-approval ...Candidates with less experience may be considered at the director level. Proficiency directly writing submission documents that support… more
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  • Vir Biotechnology, Inc. (San Francisco, CA)
    The opportunity Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all ... assigned products have a successful regulatory CMC strategy for clinical development and commercialization. You should bring both a track record of successful … more
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  • Abdera Therapeutics (San Francisco, CA)
    …meetings to provide regulatory support and guidance and manage day-to-day regulatory activities.Provide guidance and expertise to senior management and other ... experience with FDA submissions required.Skills & AbilitiesAbility to critically review regulatory scientific documents across non- clinical and clinical more
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  • Pliantrx (San Francisco, CA)
    …plans, and support program recommendations.This position will report to the Senior Director of Regulatory Affairs.ResponsibilitiesDrive key kick-off ... Director , Regulatory Affairs and Quality Project...and efficient. This person will be responsible for managing regulatory milestones from early-stage research through clinical more
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  • Biolink360 (San Francisco, CA)
    Regulatory Affairs - San FranciscoWe are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic ... and timely new product CE marking.Work closely with research and development, clinical , quality, and marketing teams to ensure regulatory considerations are… more
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  • Indapta Therapeutics Inc. (San Francisco, CA)
    …immunotherapies. The Position: Indapta seeks an experienced, biotech CMC quality professional at a director or senior director level. We offer the autonomy, ... include: Lead the CMC QA function and partner with clinical , regulatory and CMC teams, including contracted...that support excellence in quality systems and processes, informing senior leadership of the intended outcomes and results. Write… more
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  • San Francisco (San Francisco, CA)
    …(SHTG). THE ROLE Reporting to the Vice President, CMC Operations, the Head of/ Senior Director CMC Operations (Drug Substance) will manage activities related to ... THE COMPANY 89bio is a clinical -stage biopharmaceutical company focused on the development and...and data trending analysis. Write and review documents for INDs/ regulatory submissions as a technical SME to support … more
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  • Meet Recruitment Inc. (San Francisco, CA)
    Senior Director , In Vivo Pharmacology Location: South San Francisco, CAA venture backed early stage highly innovative biopharmaceutical company that has ... efficacy data.Investigate and initiate innovative approaches to identify appropriate pre- clinical and clinical biomarkers.Foster effective collaboration and… more
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  • chinesehospital-sf (San Francisco, CA)
    …Medical Staff Type Full Time Requisition # 12570 Position SummaryThe Director of Quality and Risk provides leadership, management and administrative oversite ... patient which includes internal, external, licensing departments and risk management. The Director will develop metrics in quality and patient safety, ensure all… more
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  • CLevelCrossing (Hayward, CA)
    …with workforce community stakeholders and partners. Particularly with educational and clinical institutions in TVHCs priority areas.Develop and conduct, with input ... orientations and completion of all necessary new-hire paperwork.Works with Sr. Director , HR to oversee the management of employee benefits programs, including… more
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  • Rezolute (Redwood City, CA)
    The Senior Director , Global Supply Chain will be responsible for establishing and leading the Supply Chain and Distribution organization at Rezolute. As a key ... Nimbleness, Open-minded, RespectRezolute (RZLT) currently anticipates the base salary for the Senior Director , Global Supply Chain role could range from $220,000… more
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  • Triton Medical Robotics (Burlingame, CA)
    …quality assurance and regulatory experience. Minimum 10 years of experience in Director and VP roles. Experience with bringing a product through a full ... team, technology, and investors. Title: Vice President of Quality Assurance & Regulatory Affairs POSITION SUMMARY: The company is seeking an experienced VP of… more
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  • Ascendis Pharma A/S (Palo Alto, CA)
    …and regulatory colleagues. Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation ... workplace for employees to grow and develop their skills.The Director , Regulatory Affairs will be responsible for...direct reports. Work is performed under direction of a Senior Regulatory Affairs professional. Contribute to internal… more
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  • Guardant Health (Palo Alto, CA)
    Senior Director , National Field Medical Affairs, OncologyFull-timeGuardant Health is a leading precision oncology company focused on helping conquer cancer ... test, aims to address the needs of individuals eligible for cancer screening.The Senior Director , National Field Medical Affairs, Oncology, is responsible for… more
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  • Guardant Health (Palo Alto, CA)
    Senior Medical Affairs Director , Molecular Tumor BoardsFull-timeGuardant Health is a leading precision oncology company focused on helping conquer cancer ... to address the needs of individuals eligible for cancer screening.Job DescriptionThe Senior Medical Affairs Director , Molecular Tumor Boards is responsible for… more
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  • Revolution Medicines (Redwood City, CA)
    …executive leadership and other stakeholders.Collaborate with internal departments such as clinical development, regulatory affairs, and marketing to ensure ... Revolution Medicines is a clinical -stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted… more
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  • Revolution Medicines (Redwood City, CA)
    Revolution Medicines is a clinical -stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted ... harboring mutations in the RAS signaling pathway. The Opportunity: Reporting to the Senior Vice President, the Head of US Field Medical Affairs will develop, manage,… more
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  • Elwyn (San Jose, CA)
    …to the Northern California following industry standards, where applicable, regulatory agencies, as appropriate, and Elwyn California's objectives and policies. ... The Executive Director , Northern California, in coordination with the Elwyn California...California Board of Directors, Elwyn's Chief Operating Officer, the Senior Vice President of Adult Intellectual and Developmental Disabilities… more
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  • Arcellx (Redwood City, CA)
    Who We Are Arcellx isa public, clinical -stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and ... diverse set of views and backgrounds. How You'll Make a Difference As a Senior Product Manager of Hematology Marketing, you'll use your expertise and experience in… more
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  • Senior Director - Analytical…

    Gilead Sciences, Inc. (Foster City, CA)
    …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** ... **RESPONSIBILITIES** The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of scientists, who collaborate with product… more
    Gilead Sciences, Inc. (09/03/24)
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