Vice President and Head of Clinical Development

Company: IAVI
Location: New York
Posted on: February 9, 2025

Job Description:

Vice President and Head of Clinical DevelopmentJob Category: Clinical Development, GeneralJob Title: Vice President and Head of Clinical DevelopmentLocation: New York, NY preferred; US-Remote considered; Nairobi, Kenya; Cape Town, South Africa; Remote-South Africa; Amsterdam, Netherlands, United Kingdom-RemoteReports to: Chief Development OfficerPOSITION SUMMARY:Are you an experienced Clinical Development Leader who is eager to translate science into global health impact?IAVI is seeking a Vice President, Head of Clinical Development to lead Clinical Development, playing a key role in the development and execution of the clinical pipeline strategy. The VP will provide oversight and leadership for clinical programs from FIH through licensure and life cycle management. The VP will apply their solid understanding of the functions and processes relevant to vaccine development principles, ideally also bringing experience working with funders and executing clinical trials in resource constrained environments.If you are a mission-driven clinical leader, learn more and apply below!KEY RESPONSIBILITIES:Organizational Leadership

• Develop and support the overall clinical development strategy and promote innovative approaches for IAVI's global clinical trial programs.
• Provide managerial oversight to the global clinical development team.
• Collaborate with other departmental heads to establish interdepartmental goals, work plans, and continuous process improvement of the IAVI matrix organization.
• Serve as chair of the clinical protocol review committee and as a member of relevant IAVI governance committees.
• Review and contribute to the development of grant applications and reports for donor and granting agencies.
• Work closely with leaders of the CD team to plan for immediate and future staffing needs and organizational structure optimization to successfully execute on planned early and late-stage trials.
• Ensure that all clinical trial conduct is of the utmost integrity and ethics and follows all clinical global regulations and guidelines.Clinical Trials
  • Provide guidance to protocol teams on clinical trial study design and execution.
  • Provide expert medical opinion and risk assessment for prioritization and selection of novel IAVI candidate vaccines for further development.
  • Ensure that each product has a scientifically sound, efficient, and practical clinical development plan and overall program for clinical trials execution, licensure, access, and delivery.
  • Support global regulatory submission and filing activities as needed.
  • Ensure appropriate training, procedures, and quality assurance for clinical trials.
  • Serve as a representative of IAVI at scientific, governmental, and civic assemblies as needed.
  • Ensure appropriate and timely presentation and publication of clinical trial data.
  • Establish effective working relationships with counterparts at external biotech, pharma, governmental and foundation partners to advance IAVI's strategic interests and mission.
  • Review and approve scientific and medical content of IAVI documents such as the IAVI Report and other IAVI educational materials.EDUCATION AND WORK EXPERIENCE:
    • Medical degree is required.
    • Minimum of 15 years of experience in clinical research & development, including late phase experience is required.
    • Vaccine development experience is required.
    • Significant experience in a pharmaceutical or biotech company is strongly preferred.QUALIFICATION AND SKILLS:
      • A passion for the IAVI mission.
      • Experience leading a large global team with a minimum of 5 years of significant leadership required.
      • Experience leading and successfully executing late-stage vaccine programs through licensure required.
      • Experience in preparing for and executing global clinical trials in constrained settings, especially Africa, highly preferred.
      • Knowledge of and experience with implementation of Good Clinical Practices and Human Subject Protection in clinical trials required.
      • Experience with and understanding of diverse global ethical and regulatory landscapes highly preferred.
      • Ability to communicate effectively, written or oral, to diverse audiences with cultural sensitivity.
      • Ability and willingness to travel up to 30% of the time.Organizational Overview:IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists.IAVI CORE VALUES:
        • Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
        • Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up.
        • Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect.
        • Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference.
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Keywords: IAVI, New York , Vice President and Head of Clinical Development, Executive , New York, New York