It was kind of an identity crisis because I had gone to school for all these years for a PhD, which by definition is a research degree and then to realize I didn’t really like research and could not work by myself in a lab all day. I decided I needed to think in terms of a career where I would be talking to people and challenging myself.
“I sent out more than 80 resumes and one of my interviews was with the FDA. During the interview, I asked them what kind of work I would be doing. I was told it would be a lot of writing and analysis and that sounded like something I would be more interested in, and I was hired to work there as a primary reviewer.”
“Now, when I mentor someone, I tell them, ‘If you want to know what a job is like, find someone who has it and talk to them.’ There are lots of options out there for scientists and engineers, but as an undergraduate and graduate student you don’t always know what they are.”
After working at the FDA as a primary, secondary, and tertiary reviewer, Sarah was promoted to head of two offices in the FDA’s Office of Pharmaceutical Quality—serving as the Director of the Office of New Drug Products and the interim director of the Office of Surveillance. “There’s not as much difference between the FDA and industry as people might think. Both are trying to ensure the supply of medication to patients.”
Now at Gilead, Sarah is the Executive Director/Head of Chemistry, Manufacturing and Controls (CMC) Policy, Advisory, and Intelligence, and the interim Head of Synthetic Molecules, CMC Regulatory Affairs. “I work with people from all across the industry, regulators, nonprofit organizations, lobbying firms, international companies. I’ve always liked working with people and solving challenging problems. The pharmaceutical industry is complicated, and regulatory and pharmaceutical manufacturing are not straightforward fields. I like being able to use my technical and personal skills to solve some of the very complicated challenges in the field.”
Even outside of work, Sarah uses her knowledge to help solve issues in the pharmaceutical industry. In 2021, she was appointed as the PhRMA Topic Lead for International Council for Harmonisation (ICH) M4Q(R2) and also serves as the Rapporteur of the ICH Quality Discussion Group (QDG).
“It’s an international effort with a great group of people discussing a really difficult topic. It has been more than 20 years since the guideline was updated and a lot has changed in that time. The update requires a lot of international collaboration, creativity, commitment, and understanding. You have to take into consideration all the different viewpoints from industry and regulators and negotiate to discover and create common ground.”
Additionally, Sarah is very active with ISPE. She serves as Chair of the Regulatory Steering Committee and is a Director on the ISPE International Board of Directors. “I am incredibly grateful for the opportunity ISPE has given me to work with other leaders across industry. I come away from every ISPE project I work on thinking that it is such a privilege to work with the other volunteers, to have these opportunities to lead and gain experience, and to use my own experience to help a collaborative organization that is very directly connected to patients.”
