Title 21 Cures Announcement
Center for Biologics Evaluation and Research (CBER)
OFFICE OF TISSUES AND ADVANCED THERAPIES (OTAT)
Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT)
Position: Lead Physician (Hematology)*
*Multiple selections will be made from this announcement (Malignant Hematology Branch and Nonmalignant Hematology Branch)
Series: This position may be filled with the following series: Physician (602)
Location(s): Silver Spring, Maryland
Area of Consideration: Open to the Public
Travel Requirements: 25% or less
Cures Band: Band D
Full Performance Band Level: Band D
Cures Position Type: Non-Supervisory Physician
Salary: Starting at $180,000 and is set to commensurate with education and experience.
Conditions of Employment: United States Citizenship or U.S. National.
Special Notes: This position is being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate/s selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority.
Additional information on 21st Century Cures Act can be found here.
The Food and Drug Administration (FDA) 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) 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.
The Office of Tissues and Advanced Therapies (OTAT) plans and conducts research related to the development, manufacture, and testing of cellular, gene therapy (including those utilizing naturally occurring viral vectors and those prepared by genetic engineering and synthetic procedures), therapeutic vaccines, and plasma-derived and coagulation products in order to develop and maintain a scientific base for establishing standards for safety, purity, potency, and effectiveness.
The Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) develops and maintains the Office’s Clinical, Clinical Pharmacology, and Pharmacology/Toxicology Review Programs. Provides clinical, clinical pharmacology and non-clinical review and recommends appropriate action on Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), New Drug Applications (NDAs), Investigational Device Exemptions (IDEs), Pre-Market Approval Applications (PMAs), and 510(k) submissions pertinent to products within the Office’s purview. Provides recommendations on clinical, clinical pharmacology, and non-clinical programs intended to support IND, BLA, NDA, IDE, PMA, and 510(k) submissions.
The incumbent will serve as a Lead Physician, with a specialty in Hematology, who serves as a secondary reviewer and is an and 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 OTAT regulated medical products. The 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 will:
- Serve as a source of continuity following marketing approval and regularly review the adequacy of labeling. Provides 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 OTAT.
- Leads 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 OTAT. Makes recommendations, both verbally and written, on initiative product development programs for OTAT regulated medical products.
- Serves as a DCEPT 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 OTAT regulated medical products.
- Serves 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.
Professional Experience/Desirable Qualifications:
5 years of graduate training in the specialty of the position to be filled or equivalent desired experience and Board Eligible/Board Certified in pediatric or adult hematology with experience/expertise in malignant and/or nonmalignant hematologic conditions.
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
Conditions of Employment:
- One-year probationary period may be required.
- Background and/or Security investigation required.
- U.S. citizenship is required.
- All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
- This position may be subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
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), copy of your active medical license, copy of your transcripts (unofficial), SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OTAT/DCEPT Lead Physician (Hematology)” in the subject line to: CBERHumanCapital@fda.hhs.gov.
Equal Employment Opportunity Policy
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
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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.
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- An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
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FDA is an equal opportunity employer.