FDA Data Mining in Cardiovascular Safety Model Development

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available in the 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 research opportunity supports data mining and database development efforts in the cardiovascular safety space, with a focus on advancing regulatory science through systematic analysis of nonclinical and clinical cardiotoxicity data. You will contribute to the development and curation of comprehensive databases designed to evaluate the current landscape of cardiovascular safety data used in drug development and regulatory decision-making.

You will investigate and apply advanced data mining techniques, statistical modeling, and computational tools to identify patterns, gaps, and trends across large datasets relevant to cardiac safety including human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) data, ion channel pharmacology, in vivo and clinical QT data, and other cardiotoxicity endpoints. Through this, you will collaborate with FDA scientists to analyze how real-world and experimental data can be leveraged to inform translational regulatory strategies.

This research will contribute to the development of innovative approaches for integrating large-scale cardiovascular safety datasets into the regulatory review process, advancing FDA’s regulatory science mission and public health objectives.

Learning Objectives: Under the guidance of a mentor, you will have opportunities for engagement and collaboration with internal FDA scientists and regulators, external academic researchers, and industry stakeholders. During the appointment, you will:

Gain comprehensive knowledge of FDA regulatory policies and regulations regarding the evaluation of cardiovascular safety of new drugs
Develop experience in data mining methodologies, database construction, and statistical analysis applied to cardiotoxicity datasets, including hiPSC-CM, ion channel, QT, and related cardiovascular safety data
Gain hands-on experience with computational tools and programming languages relevant to large-scale data analysis, including data visualization and reproducible research practices
Collaborate with interdisciplinary teams to investigate translational approaches that bridge nonclinical and clinical cardiovascular safety data
Present research findings at internal and external scientific conferences, contributing to the broader regulatory science community
Participate in writing scientific manuscripts that advance the field of cardiovascular safety assessment
You will gain comprehensive knowledge of FDA regulatory policies and regulations regarding the evaluation of safety and efficacy of new drugs, along with hands-on experience in regulatory science methodologies.

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

Anticipated Appointment Start Date: September 1, 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 be currently pursuing or have received a doctoral degree in the one of the relevant fields.
Point of Contact
Ashley
Eligibility Requirements
Degree: Doctoral Degree.