FDA Fellowship - Systematic Evaluation of Factors Affecting Disease Progression, Pharmacodynamics and Treatment Response in Neurodegenerative Conditions

Oak Ridge Associated Universities; Silver Spring (MD); On-site; USD 22,000 - 33,000; Full time

Job summary

FDA/CDER in Silver Spring, Maryland offers a research fellowship opportunity focusing on data-driven evaluation of disease progression and pharmacodynamics in neurodegenerative diseases, using NDA/BLA-submitted trial data. Fellows will interact with regulatory scientists and access state-of-the-art techniques.

Eligibility includes U.S. citizens, LPRs, and some foreign nationals; a bachelor's, master's, or doctoral degree in relevant fields is required or in progress.

Qualifications

• Pursuing or having completed a relevant Bachelor's/Master's/Doctoral degree.
• Interest in neurodegenerative diseases and pharmacodynamics.
• Willingness to work with NDA/BLA trial data and regulatory science.

Skills

Data collection

Data handling

Database building

Data exploration

Education

Bachelor's/Master's/Doctoral degree in relevant field

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDER-2026-0161

Application Deadline

11/20/2026 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), 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

During this appointment, you will have the opportunity to participate in the systematic evaluation of factors affecting disease progression, pharmacodynamics and treatment response in neurodegenerative conditions such as Parkinson's disease. This data-driven research will utilize clinical trial data submitted to the agency as part of NDA/BLA submissions. You will have access to unique research and training opportunities, ability to interact with top regulatory scientists and use state-of-the‑art techniques.

Learning Objectives

• Learn about various neurodegenerative diseases (e.g., Parkinson’s disease) including the pathophysiology, pharmacokinetics/pharmacodynamics of available treatment options, clinical trial designs, and drug development approaches.
• Gain expertise in data collection & handling, database building, and various contemporary data exploration/analyses techniques.
• Learn and contribute to data-driven dynamic disease-progression modeling for neurodegenerative diseases.

Mentor

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

Anticipated Appointment Start Date

October 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.

Background Investigation

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

• 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 bachelor's, master's, or doctoral degree in the one of the relevant fields.

Preference Is Given To

• Students and graduates of bachelor's or master's or;
• Doctoral degree students

Point of Contact

Ashley

Eligibility Requirements

• Degree: Bachelor's 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.)

        and

        I have read the FDA Ethics Requirements.