FDA Computational Biology and Pharmacology Fellowship

Research Project

Under the guidance of a mentor, you will help in developing comprehensive toxicology databases and computational models by analyzing proprietary data from drug applications, as well as public literature data, focusing on endpoints where New Approach Methodologies (NAMs) can provide significant regulatory value.

Research activities will include:

• Collaborating with multidisciplinary teams to curate large-scale datasets
• Investigating patterns in toxicological data using statistical methods
• Contributing to the development of reference compound libraries for predictive model validation
• Developing AI, statistical, or mechanistic models to translate nonclinical data (such as chemical structures, sequences, and in vitro functional assays for specific drugs) into safety endpoints (such as cardiotoxicity, immunogenicity, etc.)

Learning Objectives

• Structured learning opportunities in regulatory science, computational toxicology, and artificial intelligence applications in drug development
• Experience researching advanced in silico prediction algorithms, analyzing machine learning approaches for toxicity pattern recognition, and participating in developing standardized computational frameworks for regulatory assessment
• Experience in regulatory toxicology assessment, computational modeling methodologies, and FDA's drug evaluation processes
• Experience in data curation and analysis, understanding validation criteria for alternative testing methods, and acquiring knowledge of regulatory frameworks for NAM acceptance

Mentor

The mentor for this opportunity is Zhihua Li (Zhihua.Li@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

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.

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 must have been received within the past five years, or anticipated to be received by 10/31/2026.
• I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months.

Application Process

• To submit your application, scroll to the bottom of this opportunity and click APPLY.
• 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

Documents Required

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

Contact Information

• If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

Additional Resources

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Background Investigation

• Proof of health insurance is required for participation in this program.
• The participant will receive a monthly stipend commensurate with educational level and experience.
• The participant will not become an employee of FDA, DOE or the program administrator, and there are no employment-related benefits.

ORISE Education and Training Agreement

• The participant will receive a monthly stipend commensurate with educational level and experience.
• The participant will not become an employee of FDA, DOE or the program administrator, and there are no employment-related benefits.

ORISE GO Mobile App

• The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!