The incumbent serves 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.
Conditions 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.
To 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.
In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
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
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: 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, Urology
SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current FDA employee, you are not exempt from transcript requirements.
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.
Security Clearance Requirements
Background Investigation/Security Clearance Requirements: 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.
Ethics Clearance Requirements
This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
Equal Employment Opportunity
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Equal Employment Opportunity (EEO) for federal employees & job applicants
Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability employment and reasonable accommodations or how to contact an agency.
The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
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/OCE/DCEGM/GMB Physician” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through July 1, 2024.
For questions regarding this 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.