FDA/Center for Biologics Evaluation and Research
Office of Tissues and Advanced Therapies
Silver Spring, MD, USA
MD, DO, Board Eligible, Board Certified
$150,000 - $199,999
Research, Academic/Administrative, Other
March 25, 2022
March 25-May 20, 2022
The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), is actively recruiting Board Eligible/Board Certified Pediatric or Adult Hematologist with a minimum of 3 years of graduate training or equivalent experience in either malignant and/or nonmalignant hematologic conditions to serve as a Physician in our Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT). The Physician will serve as a clinical reviewer and advisor to the Division Director and other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene therapies, plasma derived protein therapeutics, certain medical devices, and other OTAT regulated medical products.
- Perform the regulatory review of a variety of regulatory submissions for a hematology indication, in either the malignant or nonmalignant specialized areas, to include but not limited to Pre-INDs, INDs, IDEs, BLAs and their amendments and supplements, and PMAs, and 510(k)s.
- Review the technology on the available literature and through their experience and knowledge, evaluates the proposed trial(s) to determine the risks and its potential benefits, and reviews the design of the protocol(s) for its ability to test the clinical hypothesis established for the study and to generate data that will be useful in the determination of its safety and effectiveness.
- Analyze, determine, and provide recommendations to sponsors on such matters as, adequacy of clinical trial data, the design of clinical studies for OTAT regulated products such as cellular and gene therapy products and plasma protein derived products, both verbally and in writing.
- Recommend guidance to sponsors regarding all phases of clinical development and develops draft clinical guidelines and procedures, Federal register statements, and special projects.
- Determine the appropriateness of the design with respect to the objectives of the study and the development of the drugs or devices; assures that reviews are completed on time, that potential benefits are weighed against reasonable foreseeable risks to human subjects, and that proposals are developed; and provides guidance to sponsors in answering questions central to drug development in a timely and safe manner.
- Evaluate the safety and adequacy of routine clinical development of cellular and gene therapy products from the first administration in humans through large, definitive trials intended to establish safety and effectiveness.
Qualifications: Must be a U.S. Citizen with Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent degree from a school in the United States or Canada. – OR – A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG). Applicants must also possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
Location: FDA White Oak Campus in Silver Spring, Maryland
Salary: Starting at $165,000 and is set to commensurate with education and experience.
About the Employer
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The Center for Biologics Evaluation and Research (CBER) mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
The Office of Tissues and Advanced Therapies (OTAT) plans and conducts research related to the development, manufacture, and testing of cellular, gene therapy (including those utilizing naturally occurring viral vectors and those prepared by genetic engineering and synthetic procedures), therapeutic vaccines, and plasma-derived and coagulation products in order to develop and maintain a scientific base for establishing standards for safety, purity, potency, and effectiveness.
The Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) develops and maintains the Office’s Clinical, Clinical Pharmacology, and Pharmacology/Toxicology Review Programs. Provides clinical, clinical pharmacology and non-clinical review and recommends appropriate action on Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), New Drug Applications (NDAs), Investigational Device Exemptions (IDEs), Pre-Market Approval Applications (PMAs), and 510(k) submissions pertinent to products within the Office’s purview. Provides recommendations on clinical, clinical pharmacology, and non-clinical programs intended to support IND, BLA, NDA, IDE, PMA, and 510(k) submissions.
How to Apply
Please submit electronic resume or curriculum vitae, copy of active medical license, copy of transcripts (unofficial), SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OTAT/DCEPT Physician (Hematology)” in the subject line to: CBERHumanCapital@fda.hhs.gov. View full vacancy announcement here: https://www.fda.gov/media/157154/download
CBER Human Capital
10903 New Hampshire Ave
Silver Spring, MD 20993 USA
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