Kevin P. Malobisky, Ph.D., M.S., RAC
Senior Vice President, Regulatory Affairs, Quality, and Pharmacovigilance
Kevin joined Karyopharm in November 2016 and is responsible for leading the strategic development and operational implementation activities across the Company’s regulatory, quality control and pharmacovigilance divisions.
Kevin brings nearly thirty years of experience in developing regulatory and development strategies and has led or participated in numerous regulatory filings for both development- and commercial-stage products across a wide range of therapeutics indications. Prior to joining Karyopharm, Kevin served as Global Head of Regulatory and Quality at Zafgen, Inc. where he led the regulatory, quality and compliance divisions. Kevin also spent fourteen years at Sanofi where he led the regulatory development for Phase 1-3 programs in fibrosis, wound repair, liver and metabolic diseases including non-alcoholic steatohepatitis, diabetes and obesity. He was also responsible for the commercial regulatory affiliate organizations in the U.S. and Canada, overseeing advertising, promotion, and compliance activities. Kevin started his career at Hoffmann-LaRoche Pharmaceuticals in virology research, in vitro diagnostic device development, and clinical/regulatory affairs.
Kevin earned his Bachelor of Science in Microbiology with a minor in Marine Sciences from the Pennsylvania State University, a Master of Science in Quality Assurance and Regulatory Affairs from the Temple University School of Pharmacy, and a Doctor of Philosophy in Organization and Management from the Capella University School of Business and Technology, graduating with distinction. Kevin is also certified in regulatory affairs (US RAC) from the Regulatory Affairs Professional Society.
Vice President, Operations