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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
Introduction
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) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s 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. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
Duties/Responsibilities
The incumbent serves as a Physician with a specialty in Neurology who is a clinical reviewer and advisor to the Branch Chief and 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 within the General Medicine Branch 2 (GMB2) and the Division of Clinical Evaluation General Medicine (DCEGM) under the Office of Clinical Evaluation (OCE) and the Office of Therapeutic Products (OTP). The Physician evaluates clinical trial designs for a variety of neurologic indications. This position reports to the GMB2 Branch Chief.
Specifically, the Physician will:
Perform the regulatory review of a variety of regulatory submissions for a neurologic indication, in neurology 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.
Provide advice and make recommendations to sponsors on such matters as, the design of clinical studies for OTP regulated products such as cellular and gene therapy products and plasma protein derived products, both verbally and in writing.
Analyze and determine the adequacy of clinical trial data submitted by the sponsor/applicants to support the safety and efficacy of cellular and gene therapy products, plasma protein derived products, and other OTP regulated products.
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.
Advise on the clinical aspects of regulatory policy related to the regulation of products developed for neurologic diseases and diseases with neurologic manifestations.
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/DCEGM/GMB2 Physician (Neurology)” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through March 6, 2025.
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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