Physician (Oncologist)

Department of Health and Human Services (HHS)
Food and Drug Administration (FDA)
Center for Biologics Evaluation and Research (CBER)
Office of Therapeutic Products (OTP)

Area of Consideration: The Public.
United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Series: 0602 (Physician)
Salary: 0602 (Physician) Starting at $165,000 and is set to commensurate with education and experience
Cures Band(s): Band C
Telework Eligible: Yes - as determined by the agency policy
Full Performance Band Level: Band C
Travel Requirements: Up to 25%

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 within the Office of Therapeutic Products (OTP). The Office of Therapeutic Products (OTP) is a newly established Super Office within CBER which is responsible for the continued safety, purity, potency, and effectiveness of cellular, tissue, and gene therapies, plasma protein therapeutics, and other products regulated by OTP. The Physician will serve as a clinical reviewer who is a reviewer and advisor to OTP and other Center senior staff for the evaluation of the safety and effectiveness of cell and gene therapies, plasma- derived products and devices, for the treatment of oncological disorders.

Specifically, the Physician will:

• Perform the regulatory review of a variety of regulatory submissions across the product development cycle to include but not limited to Pre-INDs, INDs, IDEs, BLAs and their amendments and supplements, and PMAs, and 510(k)s.
• Review the available literature and through their experience and knowledge, evaluate 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 biological products, particularly in cell and gene therapies, plasma- derived products and devices, for the treatment of oncological disorders.
• Analyze and determine the adequacy of clinical trial data submitted by the sponsor/applicants to support the safety and efficacy of biological products, particularly in cell and gene therapies, plasma- derived products and devices, for the treatment of oncological disorders.
• 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. 

Education Requirement:
Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation. 

Desired Education, Experience, or Skills:

• An ideal candidate would possess an active medical license in at least one state or U.S. federal jurisdiction.
• Knowledge and experience regarding FDA scientific and review policies is desirable Experience in clinical trial design, analysis, and/or regulation is desirable
• Expertise in one of the following fields is desirable:
  • Pediatric, Adult, Medical, Surgical, Radiation or Gynecological Oncology

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 “CURES CBER/OTP Physician” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be reviewed on a rolling basis.

Announcement Contact

For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.

View full vacancy announcement here: https://www.fda.gov/media/167689/download

The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
 

FDA is an equal opportunity employer.