DirectJobHub
Jobs · OTHR · Maryland

FDA Utilizing Artificial Intelligence to Enhance Rare Disease Research

Oak Ridge Institute for Science and Education · Silver Spring, MD · 1 mo ago
OTHRFull-time

About the role

This research opportunity is available with the U.S. Food and Drug Administration (FDA), in the Center for Drug Evaluation and Research (CDER), located in Silver Spring, Maryland. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs, to ensure safe and effective therapies reach the U.S. population.

Responsibilities

  • Investigate emerging AI methods and technologies that may support rare disease research, drug development, and regulatory science.
  • Develop and evaluate analytical approaches for identifying, organizing, integrating, and interpreting information relevant to rare diseases.
  • Assess the utility, performance, limitations, and applicability of emerging analytical tools and methodologies in rare disease settings.
  • Identify research needs, methodological gaps, and opportunities to advance rare disease regulatory science.

Learning Objectives

  • Apply emerging AI methods and technologies to rare disease research, drug development, and regulatory science.
  • Develop and evaluate analytical approaches for identifying, organizing, integrating, and interpreting rare disease–related information.
  • Assess the utility, performance, limitations, and applicability of emerging analytical tools and methodologies.
  • Understand regulatory science considerations relevant to rare diseases and emerging technologies.
  • Identify research needs, methodological gaps, and opportunities for innovation in rare disease research.
  • Collaborate with multidisciplinary scientists and researchers across data science, biomedical research, and regulatory science domains.
  • Enhance scientific communication skills through presentation and discussion of research findings and analytical results.
  • Gain exposure to real-world challenges and opportunities in applying 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 (mdrashedul.hasan@fda.hhs.gov). Questions about the nature of the research may be directed to the mentor.

Appointment Details

  • Start Date: 2026 (flexible)
  • Length: Initially one year, renewable upon recommendation of FDA and subject to funding availability
  • Level: Full time
  • Stipend: Monthly stipend commensurate with educational level and experience
  • Citizenship: U.S. citizens and Lawful Permanent Residents (LPR) only
  • Background Check: Successful completion of a background investigation by the Office of Personnel Management required
  • Note: Participants are not FDA, DOE, or program administrator employees and receive no employment-related benefits

Education

FDA requires ORISE participants to read and sign the FDA Education and Training Agreement within 30 days of start, covering topics including the non-employee nature of the appointment, intellectual property rights, and obligations regarding non-public information.

Requirements

  • Currently pursuing or having received a master’s or doctoral degree in a relevant field.
  • Degree should be received by or near the start of the appointment or within the past 5 years.

Disciplines

  • Computer, Information, and Data Sciences, including:
    • Artificial Intelligence (including Robotics, Computer Vision, Human Language Processing, and Machine Learning)
    • Computer Science (general)
    • Data Science
    • Scientific Computing and Informatics
    • Software Engineering
    • Other related subfields as listed

Eligibility Affirmation

Applicants must be U.S. citizens or have resided in the United States for at least 36 of the past 60 months and have read the FDA Ethics Requirements.

Similar jobs