Michael Szarek, Ph.D.
VP of Clinical & Regulatory Affairs
Michael leads clinical and regulatory affairs at Rgenix. He is also currently a VP at Venrock and Professor and Chair of the Department of Epidemiology and Biostatistics and Associate Dean of Research Administration at SUNY Downstate Medical Center School of Public Health. Prior to joining Rgenix, Michael was VP of Clinical and Regulatory Affairs at Stemline where he led clinical and regulatory strategy for three oncology therapeutic products.
Michael was also Senior Director of Regulatory Affairs at ImClone, where he was responsible for regulatory strategies of development-stage treatments for cancer, and Director of Biostatistics at Pfizer, where he was the worldwide statistical lead for Lipitor (atorvastatin). Michael also serves as an academic member on clinical trial Steering Committees and Data Safety Monitoring Committees, including the Executive Steering Committee of the Odyssey Outcomes Trial of Praluent (alirocumab). He received his M.S. degree in biostatistics from Harvard School of Public Health and his Ph.D. in biostatistics from New York University.