Sarah Pope Miksinski, PhD

Gilead Sciences, Inc.
Executive Director, CMC Regulatory Affairs
Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs, serving as the Head of Policy, Advisory and Intelligence. Her duties include leadership of a global team covering CMC regulatory advocacy (development and lifecycle) for health authority submissions, as well as serving as a key contributor to several ongoing global initiatives. She represents Gilead in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s Regulatory Steering Council, and supporting multiple other advocacy efforts (review/inspection standards, nitrosamines, PDUFA, and KASA). In 2021, she was appointed as the PhRMA Topic Lead for ICH M4Q(R2) and was appointed to the ISPE Board of Directors in 2022. She concurrently serves as the Rapporteur of the ICH Quality Discussion Group (QDG). Previously, Sarah served at AstraZeneca for over 5 years, holding roles in the CMC Regulatory Affairs space. Prior to that, she held a lengthy tenure at FDA, lasting from 2002-2018, where she and served as a primary, secondary and tertiary reviewer before being selected (2009) as a senior management official. She held multiple leadership roles in CDER’s Office of Pharmaceutical Quality, where she contributed heavily to many ongoing strategic and advocacy initiatives across the assessment and inspectional spaces. Prior to joining FDA, she completed a postdoctoral fellowship at the National Institute of Health. She is trained as an organic chemist and possesses a PhD in organic chemistry (Oklahoma State University, 1999). She also has a B.A. in chemistry (Earlham College, 1994).