FDA Postdoctoral Fellowship in New Approach Methodologies (NAMs)
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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.
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is 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 participant will conduct research evaluating a lung microphysiological system (MPS) as a new approach methodology (NAM) to study the disposition of anti-infective drugs in the epithelial lining fluid (ELF). This project supports the FDA’s goal of integrating predictive, human-relevant models that enhance drug development and reduce animal testing. Under the guidance of a mentor in the Division of Applied Regulatory Science (DARS), the participant will design and perform in vitro studies using the lung MPS to measure drug permeability and ELF concentration-time profiles. The participant will collaborate with interdisciplinary scientists to analyze results, compare MPS-derived profiles with clinical data, and assess translational concordance. These efforts will include identifying factors that contribute to variability between in vitro and clinical outcomes and optimizing model performance. The participant will help prepare reports, presentations, and publications advancing the regulatory application of MPS technology and may join in developing reviewer tools, templates, and training materials to support the regulatory use of lung NAMs.
Learning Objectives: Under the guidance of a mentor, you will gain comprehensive training in lung MPS setup and maintenance, primary human cell culture, and drug permeability testing. You will receive instruction in quantitative analysis using LC-MS/MS, pharmacokinetic data interpretation, and the principles of drug absorption, distribution, metabolism, and excretion (ADME). Participation in workshops, seminars, and discussions on MPS qualification and regulatory data integration will strengthen your scientific foundation. Through the program you will also improve your scientific writing, data presentation, and peer exchange skills to enhance communication and critical-thinking skills within a regulatory science setting.
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.
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 be currently pursuing or have received a doctoral degree in the one of the relevant fields.
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.
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