Marion Gruber

Marion Gruber, Ph.D., M.S., leads the development and execution of IAVI’s public health and regulatory science efforts to advance product development programs to facilitate global access to preventive and therapeutic products critical for global public health.

Prior to joining IAVI, from 1992 to 2021, Gruber served as a public health official at the U.S. Food & Drug Administration (FDA), where she held positions of increasing leadership responsibility in research, regulatory affairs, and policy. From 2011 to 2021, she was the director of the FDA’s Office of Vaccines Research and Review (OVRR). She was responsible for the review, planning, development, and administration of OVRR’s national and international programs directing a multi-disciplinary team engaged in vaccine and related biological product development, regulation, and licensure, including overseeing licensure and approval for COVID-19 vaccines. Other key responsibilities included collaboration with top agency officials, industry representatives, foreign government representatives, other national regulatory authorities as well as global organizations such as the World Health Organization and CEPI, the Coalition for Epidemic Preparedness Innovations, to advise on regulatory policy, programs, and licensure strategies for preventive vaccines to facilitate access to these products.

Gruber received a Ph.D. in microbiology from the Christian Albrecht University, Kiel, Germany and an M.S. in biology from the University of Ulm, Germany.