A Career in Government: Principal Investigator and Regulatory Affairs at the FDA

Nov. 1, 2016

Picture of Karen ElkinsWhat are the other options available for grad students besides academia and industry? We highlight a government position at the Food and Drug Administration (FDA), which includes both research and regulatory components.

We interviewed Dr. Karen Elkins, Supervisory Research Biologist in the Center for Biologics Evaluation and Research (CBER) at the FDA. She received her B.A. in Chemistry from Wake Forest University and went on to complete a Ph.D. in Microbiology and Immunology from Duke University. After completing two postdocs, she became a researcher at Walter Reed and then moved to her current job at the FDA.

Getting to the FDA

"I knew nothing about the FDA or how scientists worked within [the] FDA," she remembers. After attending many microbiology seminars on the NIH campus, which all happened to be in Building 29, she learned that Building 29 was actually the home of the Center for Biologics Evaluation and Research (CBER) of the FDA. She met several people who worked as both infectious disease researchers and regulators at CBER. "The combination of job functions sounded appealing [to me]; I enjoyed the subject matter, the lab work, and the possibility of contributing to public health through regulatory review (no matter what happened at the bench)," she comments. Karen then did something courageous; she contacted a director and asked how CBER could use someone with her infectious disease research training. The director connected her with possibilities that led to her current job. "Looking back, that took more nerve than I really knew I had at the time," she recalls.

Doing Research and Regulatory Review

Currently, her job includes two main functions that are split approximately equally. First, she is the principal investigator of a research group that studies the nature of protective immunity to intracellular bacteria. A major focus of her work is identifying correlates, such as immune mediators that can be measured in blood, that predict successful vaccination against bacteria like Mycobacterium tuberculosis and Francisella tularensis. Second, she serves as a product reviewer for investigational bacterial vaccines that are regulated by the FDA as they proceed through clinical trials. She is responsible for evaluating the plans for manufacturing, quality control testing, and clinical immunogenicity testing.

Because of her extensive background in research, she easily transitioned into the role of principal investigator, which includes tasks like working with her group members to design projects and experiments, reading the literature, writing papers, reviewing manuscripts and grants, and executing experiments. The regulatory side of her job was accompanied by an initial learning curve; however, she quickly became skilled at the regulatory review process. In this process, products are evaluated for their characterizations, data that manufacturers submit are scrutinized, the information about the product and its claims are reviewed, and any FDA issues that were identified are communicated to the manufacturers. The entire process is done with a team of clinical and statistical reviewers to ensure that the clinical trials were done to maximize protection of patients and yield useful data.

Consider Your Career Options and Network

For those that are interested in working at the FDA, Karen says, "the prospects for knowledgeable, thoughtful scientists working in government in non-bench positions (such as FDA regulation) are rather good, and they seem likely to stay stable." While Karen has a research component to her job, there are many Ph.D. and master's level scientists who work at the FDA in full-time regulatory positions.

Looking back, Karen says, "I never would have predicted that I'd end up in FDA - or like it well enough to stay for over 20 years now". She encourages people to be open to unexpected possibilities and to become comfortable with networking. "Odds are that's where most of your best job possibilities will come from," she comments. Also, she recommends mastering a scientific topic that fascinates you regardless of its marketability and to demonstrate that mastery through published papers and techniques. "Dive deep to learn as much theoretical knowledge and technical information about it as you can, and then build your knowledge outwards from there." Lastly, she advises that students build their non-technical skills, such as writing effectively, producing engaging presentations, and managing projects from the strategic planning steps to budgets.

Author: Shilpa Gadwal

Shilpa Gadwal
Shilpa Gadwal is the Career Resources Specialist at ASM.