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Summary:
The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective; that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe; and that all such products marketed in the U.S. are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated.
The mission of the Center for Biologics Evaluation and Research (CBER) 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.
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
Duties:
The incumbent serves as the Lead Physician (Team Lead) for the Benign Hematology Branch (BHB) within the Division of Clinical Evaluation Hematology (DCEH) under the Office of Clinical Evaluation (OCE), Office of Therapeutic Products (OTP). This position reports to the Branch Chief. The Lead Physician (Team Lead) has a specialty in Hematology, who serves as a secondary reviewer and is one of the principal advisors 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 OTP regulated medical products. The Lead Physician evaluates clinical trial designs for a variety of hematologic indications. This position can operate in either the Malignant Hematology Branch or the Benign Hematology Branch, as appropriate.
Specifically, the Lead Physician (Team Lead) will:
Serve as a source of continuity following marketing approval and regularly review the adequacy of labeling.
Provide secondary reviews (and infrequently primary reviews) of the results of studies or other information to determine the adequacy of clinical post- marketing requirements and commitments.
Serve as a general resource to more junior staff to evaluate clinical trial designs and interpret regulations and guidance regarding the standards of safety and effectiveness for products regulated by OTP.
Lead reviews to include assigning and evaluating work of team members on a regular and recurring basis.
Perform regulatory review responsibilities that may include, but are not limited to, coordinating the review of INDs, IDEs, BLAs and their amendments and supplements, PMAs, 510(k)s), and product labeling.
Assure that scientific reviews of regulatory submissions such as INDs, IDEs, BLAs, etc. are incorporated into a final assessment addressing all key aspects of the product(s) and proposed clinical trials.
Provide authoritative advice to sponsors on such matters as, the design of clinical studies for products regulated by OTP.
Make recommendations, both verbally and written, on initiative product development programs for OTP regulated medical products.
Serve as a DCEH Branch spokesperson and recognized authoritative source of information on matters related to the development of new regulations and guidance documents pertinent to cell and gene therapy, plasma protein therapeutics and other OTP regulated medical products.
Serve as an authoritative scientific expert that is sought by peers with respect to issues related to these products manufacturing, characterization, specification, and safety testing, and as to the adequacy of design, implementation, and analysis of clinical trials.
How to Apply:
Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), SF50 (if applicable), latest PMAP (if applicable), unofficial transcripts and letter of interest with “Title 21 CBER/OCE/DCEH/BHB Lead Physician (Team Lead)” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through December 16,2024.
Announcement Contact:
For questions regarding this Title 21 (Cures) position, please contact CBERHumanCapital@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer.
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