FDA Fellowship in Quantitative Regulatory Science: Integrating Nonclinical and Clinical Data to Support Targeted Therapy Development

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 40,000 - 54,000; Full time

Job summary

Oak Ridge Institute for Science and Education is offering a fellowship with FDA/CDER in Silver Spring, MD. You will work under a mentor to advance regulatory science through computational modeling and data-mining approaches.

The program emphasizes learning in regulatory toxicology, AI applications in drug development, and presenting results at conferences. Applicants must have a Master’s or Doctoral degree in a relevant field and may be US citizens, permanent residents, or eligible for

Qualifications

• This opportunity requires a Master's or Doctoral degree in one of the relevant fields.
• Discipline areas include Computer, Information, and Data Sciences, AI, Computer Science, Data Science, and related fields.
• Background in regulatory science or toxicology is preferred.
• Excellent analytical and communication skills are required.
• Eligibility includes U.S. citizenship, permanent residency, or approved visa statuses.

Responsibilities

• Under mentor guidance, develop regulatory science and modeling skills for drug development decisions.
• Apply Model-Informed Drug Development approaches to support safety characterization and dosing strategies.
• Prepare findings for internal/external conferences and scientific manuscripts.

Skills

Regulatory science

Computational modeling

Data mining

AI/ML applications

Regulatory toxicology

Education

Master's Degree OR Doctoral Degree in relevant fields

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0180

Application Deadline

12/4/2026 3:00:00 PM Eastern Time Zone

All documents must be in English or include an official English translation.

If you have questions, send an email to [e-mail]. Please include the reference code for this opportunity in your email.

Description

• Applications will be reviewed on a rolling-basis.

FDA Office and Location

Office of Translational Sciences (OTS) Office of Clinical Pharmacology (OCP) Division of Applied Regulatory Science (DARS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) located in 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

This fellowship focuses on advancing the regulatory science of targeted therapies, including peptides and oligonucleotide therapeutics (ONTs), through the integration of nonclinical safety data evaluation and Model-Informed Drug Development (MIDD) approaches. Under the guidance of a mentor, you will investigate how available nonclinical and early clinical data can be leveraged more effectively to support key drug development decisions — including the characterization of safety profiles and the optimization of dosing strategies — in ways that complement or improve upon conventional development paradigms.

Learning Objectives

As a participant, you will have structured learning opportunities in regulatory science and computational modeling applications in drug development and use of artificial intelligence for data mining. You will 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. The appointment will also allow opportunities to present research results at internal and external scientific conferences and participate in writing high-impact scientific manuscripts.

Mentor

The mentor for this opportunity is Lars Johannesen ([e-mail]). If you have questions about the nature of the research, please contact the mentor.

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.

Qualifications

The qualified candidate should have received or be currently pursuing a master's or doctoral degree in one of the relevant fields.

Point of Contact

Ashley

Eligibility Requirements

• Degree: Master's Degree or Doctoral Degree.
• Discipline(s):
  • Computer, Information, and Data Sciences
  • Artificial Intelligence (including Robotics, Computer Vision, Human Language Processing, and Machine Learning)
  • Computer Architecture and Grids
  • Computer Science - Languages and Systems
  • Computer Science - Theoretical Foundations
  • Computer Science (general)
  • Computer Systems Analysis
  • Computer Systems Design (including Signal Processing)
  • Data Science
  • Databases, Information Retrieval, and Web Search
  • Graphics and Visualization
  • Human Computer Interaction
  • Information Science and Technology
  • Information Security and Assurance
  • Networks and Communications
  • Operating Systems and Middleware
  • Scientific Computing and Informatics
  • Software Engineering
• Engineering (29 )
• Life Health and Medical Sciences (51 )
• Mathematics and Statistics (11 )

Affirmation

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.)