Sarah C. Pope Miksinski PhD

Sarah Pope Miksinski joined Gilead in July 2023 and serves as Executive Director in CMC Regulatory Affairs, where she leads a global team focused on regulatory advocacy for health authority submissions. She also contributes to global initiatives and represents Gilead in external roles, including on PhRMA’s Global Quality and Manufacturing Committee and as Chair of ISPE’s Regulatory Steering Council. Sarah was appointed PhRMA Topic Lead for ICH M4Q(R2) in 2021 and joined the ISPE Board of Directors in 2022. She also serves as Rapporteur of the ICH Quality Discussion Group.

Sarah has worked at AstraZeneca in CMC Regulatory Affairs and 16 years at the FDA, where she held senior leadership roles in CDER’s Office of Pharmaceutical Quality. She completed a postdoctoral fellowship at the National Institutes of Health and holds a PhD in organic chemistry from Oklahoma State University, along with a BA in chemistry from Earlham College.