Office of Clinical Pharmacology
OCP ORISE Fellowship Program for Training in Policy Development and Regulatory
Science (OCP Policy and Research Fellowship) 2021-2022
The Office of Clinical Pharmacology (OCP) at the U.S. Food and Drug
Administration (FDA) is seeking interested individuals for a one-year ORISE
(Oak Ridge Institute for Science and Education) fellowship to conduct
regulatory research on OCP and FDA policy priority topics that will advance new
drug development and promote therapeutic individualization. For more
information on timeline and past fellow projects, please visit this site OCP
Policy and Research website. Potential project topics are diverse and will be
instrumental in informing the development of both scientific and regulatory
guidelines and policies. Possible project topics can include programmatic
evaluation of clinical pharmacology-informed regulatory decisions (e.g., model
informed drug development, citizen's petitions, reviews, regulatory milestone
communications, etc.).
At FDA, OCP is housed within the Center for Drug Evaluation and Research (CDER)
and is a dynamic organization with a mission to improve public health by
enabling patient-centered regulatory decisions of the highest quality. For more
information about OCP, please visit OCP's website.
The OCP fellowship will include three components: 1) OCP and FDA regulatory
research, 2) self-guided didactic training through the FDA scientific and
professional courses, and 3) additional projects and activities for
fellow-specific professional development. Fellowship mentoring will also be
determined by the fellow's style and professional interests.
For more information about FDA ORISE fellowships, please visit
https://orise.orau.gov/fda/. Prospective fellows should have an advanced degree
in a STEM or health-related field (e.g., MS, PhD, PharmD, and/or MD) received
within 5 years of August 2021. Because of ORISE security requirements, foreign
nationals must have resided in the U.S. for at least three of the past five
years. Additionally, the candidate should possess excellent analytical,
research, and communication skills, and have a profound interest in leading
projects that advance regulatory science and public health.
To apply, email the following to [email protected] no later than April
30, 2021:
* A short introductory paragraph (4-8 sentences)
* Current CV
The subject line should be 'OCP Policy and Research Fellowship'. The
anticipated fellowship start date is between late Summer to early Fall 2021.