Marion F. Gruber, Ph.D., M.S., is a global leader in vaccine regulation and development with more than 30 years of experience spanning regulatory science, clinical development, and public health policy. She currently serves as Vice President for Public Health and Regulatory Science at the International AIDS Vaccine Initiative, where she leads regulatory and public health strategies to advance vaccines and biologics addressing global health priorities.

Dr. Gruber previously spent nearly three decades at the U.S. Food and Drug Administration, including 10 years as Director of the Office of Vaccines Research and Review (OVRR) within CBER. In this role, she led multidisciplinary teams responsible for the evaluation and approval of numerous vaccines, including the first licensed COVID-19 vaccine in the United States, the Ebola vaccine, and multiple vaccines targeting influenza, pneumococcal disease, HPV, hepatitis B, and other infectious diseases.

An internationally recognized expert, Dr. Gruber advises global health organizations and industry on vaccine development and regulatory strategy. She is a member of the International Alliance for Biological Standardization and serves on the steering committee of the FEEVA (Framework for Evidence Evaluation in Vaccine Assessment) initiative. She is also a core regulatory expert on a Coalition for Epidemic Preparedness Innovations-funded effort to develop correlates of protection playbooks for emerging infectious diseases, and has served as an advisor to the World Health Organization, contributing to global vaccine policy and safety oversight.

Dr. Gruber holds a Ph.D. in Microbiology from the Christian Albrecht University of Kiel and a Master’s degree in Biology from the University of Ulm, Germany.