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Job Title: FDA Comparative Gaps Analysis in Sickle Cell Disease Fellowship
Job Number:
Organization: US Food and Drug Administration (FDA)
Posted: 1/6/2022
Type: Full-Time
Number of Openings: 1
Location: Silver Spring,  MD    USA
Position Description: *Applications will be reviewed on a rolling- basis.

A research opportunity is currently available in the Office of New Drugs (OND)/ Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland. 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 FDA, CDER regulates over-the- counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

Conducting clinical trials and developing new therapies meeting unmet needs of patients with Sickle Cell Disease (SCD) have been challenging due to large gaps in our current understanding of the natural course of the disease and its variable manifestations from one patient to the next. There is also a lack of consistent scientific data to facilitate informed regulatory decision-making that may lead to significant health improvements in the SCD community. The project is designed to address these gaps through strategic analysis between the clinical trial data that supported FDA approved for SCD therapeutic products and real world data at CDC SCDC.

Under the guidance of the mentor, the participant will learn to create a SCD clinical trial database with available data, compare and define critical gaps between clinical trial data and the real world data, and develop strategies/tools to predict outcomes in SCD.

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 initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Qualifications: The qualified candidate should have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.

Organization Description:

Closing Date: 4/6/2022
Desired Starting Date:
Contact Name: N/A N/A,  FDA Comparative Gaps Analysis in Sickle Cell Disease Fellowship
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How to Apply: Applications must be completed in Zintellect at the Web Address provided.

Additional Information:

Web Site Delete Date: 4/6/2022