What are the responsibilities and job description for the FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation position at U.S. Food and Drug Administration (FDA)?
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available in the Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. The Center for Drug Evaluation and Research 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, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.
Research Project: Some biomarkers have been used as multiple roles through one drug development such as a diagnosis biomarker for patient enrollment at the early stage and later drug treatment effect assessment as pharmacodynamic effect to support the drug effectiveness as a PD biomarker or an efficacity surrogate biomarker. The bioanalysis has to be adjusted accordingly to adequately fit for supporting the updated role. This research is to identify the bioanalysis gap. In this bioanalysis gap analysis.
The participant will be involved in the review of biologics license applications (BLAs) approved in recent 10 years (2015-2025) to identify biomarkers which have been used in diagnosis and assess the biomarker roles and associated bioanalytical methods to identify the landscape of a bioanalysis gap. This analysis could provide the scientifical rationales for the appropriateness of bioanalysis of biomarker in different roles to fill out the gap and improve the drug development efficacy when using biomarkers and thus expand the usage of biomarker to more drug development and thus to expedite the drug development overall and bring more drugs to patients early.
Learning Objectives: Under the guidance of the mentors, you will have the following learning outcomes;
- Learn the FDA database navigation system
- Learn how the biomarker assists the drug development process
- Master the bioanalysis of PD biomarker guidance and best practice in industry
- Understand the scientific considerations in regulatory decision making
Through your training, you will be able to develop strong critical thinking, improve skills in information extraction and summarization, and scientific communication.
Mentor: The mentors for this opportunity are Xiulian Du (Xiulian.Du@fda.hhs.gov) and Yow-Ming Wang (Yowming.Wang@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 twelve months, 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.