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

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

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

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*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A Fellowship opportunity is available with Dr. Chava Kimchi-Sarfaty and located at Hemostasis Branch 1 (HB1), Division of Hemostasis (DH), Office of Plasma Protein Therapeutics (OPPT), Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER) in Silver Spring, Maryland. Funding for this opportunity will be provided by the Office of Commissioner (OC), Office of Women's Health (OWH).

The Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration are educational and training programs designed to provide students and recent graduates, opportunities to participate in project-specific research and developmental activities at the Office of Women’s Health (OWH). OWH mission is to address issues of women’s health and coordinate efforts to establish and advance a women’s health agenda for FDA.

Research Project: Under the guidance of the mentor, the participant will investigate sex-biased microRNAs (miRNAs) and their regulatory effects on coagulation proteins, with an initial focus on ADAMTS13 and potential extension to other targets such as von Willebrand Factor (VWF) and Factor IX (FIX). The project will evaluate whether sex-biased miRNAs can bind to the coding sequence (CDS) and untranslated regions (UTRs) of coagulation factor transcripts and regulate protein expression. In addition, the participant will assess whether known genetic variants disrupt miRNA interactions by causing loss or gain of miRNA binding sites, potentially altering protein function and contributing to sex-dependent differences in bleeding disorders such as thrombotic thrombocytopenic purpura (TTP) and von Willebrand Disease (VWD).

The research will utilize bioinformatics and in-silico approaches, including SNP databases, miRNA databases, sequence analysis tools, and, where feasible, AGO-CLIP datasets, to develop a streamlined strategy for predicting miRNA binding sites and evaluating the effects of genetic variants on these interactions. This aims to support FDA regulatory science efforts by improving understanding of factors that may influence the quality, safety, and efficacy of FDA-regulated products relevant to women’s health and precision medicine applications.

Learning Objectives: Through this opportunity, you will:

• Develop understanding of sex-biased miRNA regulation in hemostasis and coagulation protein expression
• Learn to apply bioinformatics and in-silico prediction tools to identify miRNA-target gene interactions within CDS and UTR regions
• Gain experience using publicly available genomic, transcriptomic, SNP, and miRNA databases for regulatory sequence analysis
• Learn approaches for predicting how genetic variants may disrupt or create miRNA binding sites and alter regulatory interactions
• Develop skills in sequence analysis, variant annotation, and interpretation of miRNA–mRNA interaction datasets, including AGO-CLIP resources where applicable
• Understand computational strategies for evaluating coagulation-related genes and variants associated with bleeding disorders
• Apply acquired knowledge to support FDA regulatory science and women’s health research initiatives through computational evaluation of sex-specific regulatory mechanisms in coagulation biology

Mentor: The mentor for this opportunity is Chava Kimchi-Sarfaty (chava.kimchi-sarfaty@fda.hhs.gov). 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 two years, 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.

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. 

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.

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields (e.g. molecular and cell biology, pharmacology and drug discovery/development). Degree must have been received within the past five years or anticipated to be received by 10/1/2026.

Preferred skills:

• Lab skills in common molecular and cell biology techniques are preferred.

• Degree: Master's Degree or Doctoral Degree received within the last 60 months or anticipated to be received by 10/1/2026 12:00:00 AM.
• Discipline(s):
  • Life Health and Medical Sciences (51 )

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.