FDA Utilizing Artificial Intelligence to Enhance Rare Disease Research

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 60,000 - 80,000; Full time

Job summary

FDA seeks an ORISE Fellow to join the CDER team in Silver Spring, MD, exploring emerging AI methods for rare disease research and regulatory science. You will work with scientists to identify information needs and develop analytical approaches to organize and interpret complex data.

The role emphasizes evaluating new tools, understanding regulatory considerations, and communicating findings to multidisciplinary teams, with a one-year appointment that can be renewed depending on funding and

Qualifications

• Master's or PhD in a relevant field is required or recently completed.
• Experience with AI, regulatory science, or rare disease research is beneficial.
• Ability to develop and evaluate analytical methods for data interpretation.

Responsibilities

• Investigate emerging AI methods and technologies for rare disease research and regulatory science.
• Develop and evaluate analytical approaches for organizing and interpreting rare disease–related information.
• Assess utility and limitations of new analytical tools in regulatory science contexts.
• Collaborate with multidisciplinary scientists across data science, biomedical research, and regulatory science domains.

Education

Master's or PhD in relevant field

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0171

Application Deadline

11/6/2026 3:00:00 PM Eastern Time Zone

Description

Applications will be reviewed on a rolling-basis.

FDA Office and Location

A research opportunity is available immediately with the Food and Drug Administration (FDA), in the Center for Drug Evaluation and Research (CDER), 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

As an Oak Ridge Institute for Science and Education (ORISE) participant, you will join and learn from a community of scientists and researchers in an effort to investigate emerging AI methods and technologies that may support rare disease research, drug development, and regulatory science. You will have the opportunity to participate in developing and evaluating analytical approaches for identifying, organizing, integrating, and interpreting information relevant to rare diseases. Additionally, you will assess the utility, performance, limitations, and applicability of emerging analytical tools and methodologies in rare disease settings. You will identify research needs, methodological gaps, and opportunities to advance rare disease regulatory science.

Learning Objectives

• Gain experience applying emerging AI methods and technologies to rare disease research, drug development, and regulatory science
• Learn to develop and evaluate analytical approaches for identifying, organizing, integrating, and interpreting rare disease–related information
• Build skills in assessing the utility, performance, limitations, and applicability of emerging analytical tools and methodologies
• Develop an understanding of regulatory science considerations relevant to rare diseases and emerging technologies
• Strengthen your ability to identify research needs, methodological gaps, and opportunities for innovation in rare disease research
• Hone the skills necessary to participate alongside multidisciplinary scientists and researchers across data science, biomedical research, and regulatory science domains
• Enhance scientific communication skills through the presentation and discussion of research findings and analytical results
• Gain exposure to real-world challenges and opportunities in the application of AI to biomedical and regulatory decision-making
• Develop critical thinking skills for evaluating emerging technologies in complex and data-limited rare disease settings

Mentor

The mentor for this opportunity is Rashed Hasan ([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 and Lawful Permanent Residents (LPR) only.

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.

Education

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.

Qualifications

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields. Degree should be received by or near start of appointment or have been received in the past 5 years.

Point of Contact

Ashley

Eligibility Requirements

• Citizenship: LPR or U.S. Citizen
• Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.
• 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

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.)

and

I have read the FDA Ethics Requirements.