FDA Computational Biology and Pharmacology Fellowship
To submit your application, scroll to the bottom of this opportunity and click APPLY.
A complete application consists of:
- An application
- Transcripts – Click here for detailed information about acceptable transcripts
- A current resume/CV, including academic history, employment history, relevant experiences, and publication list
- One educational or professional recommendation
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.
Connect with ORISE...on the GO! Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: Multiple opportunities are available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS) located at Silver Spring, Maryland.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.
Research Project: The Office of Clinical Pharmacology (OCP) and Office of New Drugs (OND) are creating new and updating existing toxicity databases based on available nonclinical animal data (and available clinical data where applicable) that could be used in validation of human-based in vitro and computational methods submitted to FDA for regulatory use. The developed models will be used to predict various toxicity endpoints and drug exposure to help provide foundational knowledge and experience enabling FDA staff to integrate New Alternative Methods (NAMs) in into drug evaluation.
Under the guidance of a mentor, you will assist in developing comprehensive toxicology databases by analyzing proprietary nonclinical data from drug applications, focusing on endpoints where NAMs can provide significant regulatory value. Research activities will include collaborating with multidisciplinary teams to curate large-scale datasets, investigating patterns in toxicological data using statistical methods, contributing to the development of reference compound libraries for predictive model validation, and developing AI, statistical, or mechanistic models to translate nonclinical data (such as chemical structures, sequences, and in vitro functional assays for specific drugs) into safety endpoints (such as cardiotoxicity, immunogenicity, etc.)
Learning Objectives: As a participant, you will have structured learning opportunities in regulatory science, computational toxicology, and artificial intelligence applications in drug development. You will gain experience researching advanced in silico prediction algorithms, analyzing machine learning approaches for toxicity pattern recognition, and participating in developing standardized computational frameworks for regulatory assessment. You will also gain experience in regulatory toxicology assessment, computational modeling methodologies, and FDA's drug evaluation processes. Additionally, you will develop competencies in data curation and analysis, understand validation criteria for alternative testing methods, and acquire knowledge of regulatory frameworks for NAM acceptance. Training components include mentorship with senior CDER scientists, participation in stakeholder engagement activities with industry and academic partners, and hands-on experience with data management systems and quality control procedures.
Mentor: The mentors for this opportunity are Jeffry Florian (Jeffry.Florian@fda.hhs.gov) and Zhihua Li (Zhihua.Li@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentors.
Anticipated Appointment Start Date: 2026. Start date is flexible and will depend on a variety of factors.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full-time.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.
Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA Ethics Requirements
If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
- Non-employee nature of the ORISE appointment;
- Prohibition on ORISE Fellows performing inherently governmental functions;
- Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
- The fact that research materials and laboratory notebooks are the property of the FDA;
- ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
The qualified candidate should have received a master's or doctoral degree in the one of the relevant fields. Degree must have been received within the past five years.
I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
and
I have read the FDA Ethics Requirements.
ORISE GO
The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!
