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Company: Food and Drug Administration, Center for Biologics
Location: Silver Spring
Posted on: February 12, 2024

Job Description:

Duties/ResponsibilitiesServes as a Physician within one of the General Medicine Branches within the Division of Clinical Evaluation General Medicine (DCEGM), Office of Clinical Evaluation (OCE), 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 DCEGM, OCE, OTP 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.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 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 reasonably 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.Desired Education, Experience, and 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:
      • Internal Medicine or Pediatrics or any of the Internal Medicine or Pediatric subspecialties to include but not limited to: Allergy/Immunology, Cardiology, Endocrinology, Gastroenterology, Infectious Disease, Medical Genetics, Pulmonary, Rheumatology, Neonatology, Nephrology
      • Dermatology, Neurology, Ophthalmology
      • Family Practice, General Surgery, Orthopedics, Sports Medicine, Physical Medicine, and Rehabilitation
      • Obstetrics/Gynecology, UrologyConditions of Employment
        • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
        • Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
        • Applicants must meet all qualification requirements by the closing date of this announcement.
        • Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
        • FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
        • Males born after December 31, 1959, must be registered with the Selective Service.
        • Financial Disclosure may be required.
        • Ethics Clearance may be required.
        • Background Investigation/Security Clearance is required. All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.QualificationsTo be placed into a Cures position, candidates must meet the following criteria:
        • Scientific, Technical, and Professional Fields
        • Qualified and Outstanding Candidates
        • Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
        • Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.Education RequirementCandidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Navigate to the following link to determine the series for which you qualify: standards/#url=List-by-Occupational-SeriesHow to ApplyPlease 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/OCE/DCEGM/GMB Physician" in the subject line to: Applications will be accepted through July 1, 2024.Announcement ContactFor questions regarding this Cures position, please contact This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The Department of Health and Human Services, Food and Drug Administration is an equal opportunity employer with a smoke-free environment.To view the full announcement, please navigate to Information:Starting At $165000.0 / AnnuallyDetails:Starting at $165,000 and is set to commensurate with education and experience.

Keywords: Food and Drug Administration, Center for Biologics, Silver Spring , Physician, Healthcare , Silver Spring, Maryland

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