Chief Medical Officer
IAVI is searching for an exceptional candidate to be our Chief Medical Officer who will lead development and execution of clinical strategy for vaccine and biologics candidates for HIV, TB and selected emerging infectious diseases. The position will be based in IAVI’s Headquarters (New York) and the person will lead the clinical operations at headquarters as well as our global locations.
Title: Chief Medical Officer
United States, New York (preferred)
• Lead IAVI in development of innovative and efficient clinical strategies to develop safe and effective vaccines and biologics for populations in need, including both early and advanced clinical development.
• Ensure that each product has a scientifically sound, efficient and prudent Clinical Development Plan (CDP) that meets the needs of IAVI and partner organizations.
• Provide advice regarding human subject research, to ensure that IAVI’s clinical research is conducted to the highest scientific and ethical standards, and in compliance with national and international guidance, including subject safety in all IAVI sponsored clinical research.
• Align clinical research efforts of Africa and India Regional programs, and the USAID-funded ADVANCE program to that of IAVI priorities, by providing strategic and operational guidance.
• Review and advise on all proposals for IAVI-supported research projects that are intended to create clinical vaccine and monoclonal antibody candidates.
• Review and approve, from a medical perspective, all clinical trials, epidemiologic studies, and social science studies involving potential or actual clinical trials or epidemiology study participants.
• Review and approve all regulatory documents submitted by IAVI that relate to clinical trials
• Interface, with Regulatory Affairs, for FDA, MHRA (UK), PEI (Germany), other regulatory authorities; oversee regulatory and ethics committee interactions in Africa and Asia.
• At clinical sites in Africa, US, Europe, India or other appropriate locations, sponsor Phase 1-2 studies for initial evaluation of safety and immunogenicity; support efficacy trials.
• Explore and develop innovative trial designs to obtain information about candidates more efficiently.
Representing IAVI and Working with External Partners:
• Represent IAVI to increase collaboration and leverage synergies in the emerging infectious disease prevention fields. This will include participation and presentations at national and international scientific meetings, interacting with IAVI donors, stakeholders and Scientific Advisors, serving on key initiatives/ partnerships and interfacing with scientific and political leadership in the developing world where IAVI conducts the majority of its clinical research.
• Represent IAVI to scientific, governmental and civic organizations.
• Establish effective working relationships with clinical equivalents at external biotech, pharma, government and foundation partners to advance IAVI’s strategic interests and mission.
• Provide clinical development expertise and high quality clinical operational support services for partners through the IAVI Product Development Center.
• Ensure that Good Clinical Practices and regulatory guidelines are met at all IAVI partner sites and that clinical trials are conducted in a scientifically and medically sound and ethical manner.
Managing Clinical Development Team
• Manage a large and globally dispersed team and ensure adequate training, procedures and quality assurance for clinical trials and research studies.
• Work with teams to ensure that preclinical and clinical development plans and regulatory strategy are aligned.
• Assure that the work of Clinical Development team is presented in appropriate conferences and published in a timely way.
• Provide managerial oversight for clinical operations for all IAVI trials and studies working closely with the Senior Director, Global Clinical Operations
• In collaboration with Human Immunology Laboratory, ensure laboratory assays are available to support clinical trials.
• Serve as a member of R&D Leadership Team and Senior Management Team.
• Establish close partnership with other senior members of IAVI to ensure integration across the product development lifecycle.
• Initiate, review, and assist with fundraising proposals to government, foundations and private donors.
• Collaborate with internal groups at IAVI that require medical expertise to ensure use and release of accurate and appropriate medical information.
Experience and Skills:
• Passion for IAVI Mission
• Medical degree, >15 years’ experience in clinical research. Board certification in Medicine, Internal Medicine, Infectious Diseases highly desirable.
• Record of accomplishment with peer-reviewed publications in AIDS and HIV research, infectious diseases, immunology and/or epidemiology, with experience in development of vaccines and monoclonal antibodies strongly preferred.
• Experience in pharmaceutical company strongly preferred, particularly with regulatory interactions.
• Experience leading a diverse team with a global distribution.
• Ability to communicate effectively, written or in person, with diverse audiences, from activists to regulators, including sensitivity to cultural diversity.
• This position will require international travel, which may be 25% of the time.