Molly E. Shea, PhD, is a global regulatory strategist with over 18 years of drug development and regulatory science experience gained in the biopharmaceutical industry and U.S. Food and Drug Administration (FDA). Her experience spans from bench through clinical studies to post-marketing regulatory strategies. Dr. Shea has supported product development for a wide range of disease areas and drug modalities, including small and large molecules.
Prior to joining Atsena, Dr. Shea held Vice President of Regulatory Affairs roles at Voyager Therapeutics, Akebia Therapeutics, and, most recently, Scholar Rock, Inc. Previously, Dr. Shea was an Executive Director, Global Regulatory Affairs at Novartis leading regulatory strategies and teams for a range of neurological diseases with the successful global filing and approval of AIMOVIG® in partnership with Amgen. Additionally, while a Director of Regulatory Affairs at Teva Pharmaceuticals in its branded products group, Dr. Shea led the filing and approval of ProAir RespiClick®.
Prior to Dr. Shea’s time in industry, she was a primary nonclinical reviewer/assessor and subsequently a Nonclinical Supervisor at FDA for approximately 8 years.
Dr. Shea completed her doctorate degree in Pharmacology at the University of Minnesota Medical School.