Kevin P. Malobisky, Ph.D., M.S., RAC
Kevin P. Malobisky, Ph.D., M.S., RAC is a regulatory and quality professional with over 26 years of experience in global leadership, management, and strategy with a focus in clinical research and development, regulatory affairs, quality, pharmacovigilance, and operations in the pharmaceutical and biotechnology arena.
Dr. Malobisky has extensive experience developing and leading early, late-phase, and commercial regulatory and development strategies with the U.S. Food and Drug Administration and other global health authorities. He has also led and participated in numerous regulatory filings across a wide range of therapeutic domains and directed the preparation for an FDA advisory committee meeting and numerous risk mitigation and management strategies for development and commercial products. Prior to joining Karyopharm Therapeutics, Dr. Malobisky was the global head of regulatory and quality at Zafgen, a biopharmaceutical company focused on metabolic and rare diseases. Kevin earned his B.S. degree in Microbiology from the Pennsylvania State University, his M.S. in Regulatory Affairs and Quality Assurance from Temple University School of Pharmacy, and his Ph.D. in Organization Management from Capella University School of Business and Technology. Kevin is also certified in regulatory affairs (US RAC) from the Regulatory Affairs Professional Society.