Branch Chief

Company/Institution: FDA/Center for Biologics Evaluation and Research
Department: Office of Tissues and Advanced Therapies
Location: Silver Spring, MD, USA
Degree Requirements: MD, DO, Board Eligible, Board Certified Salary: $150,000 - $199,999
Job Type: Faculty, Research, Other Posted: March 25, 2022
Job Setting: Other Application Period: March 25-May 20, 2022

The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT), is actively recruiting Board Eligible/Board Certified Pediatric or Adult Hematologist with a minimum of 5 years of graduate training or equivalent experience in either malignant or nonmalignant hematologic conditions to serve as a Branch Chief in our Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT). The Branch Chief guides the clinical review program which include evaluating clinical data and protocols that involve biological products, especially cell and gene therapies, plasma derived products and devices, for the treatment of hematologic disorders. Duties/Responsibilities: - The incumbent will serve as Supervisory Physician (Hematology) responsible for managing and supervising staff and overseeing work focused on hematologic conditions. Depending on the branch, responsibilities will include oversight of either malignant hematologic disorders or nonmalignant hematologic disorders. - Develops policy and/or research regarding hematology related clinical issues, such as trial design issues and safety. Oversees the development of written policies, identifies critical problems in clinical trial methodology. - Directs the clinical review program in evaluating clinical data and protocols that involve biological products, especially cell and gene therapies, plasma derived products and devices, for the treatment of hematologic disorders. - Provides guidance to sponsors regarding all phases of clinical development. Engages in developing hematology related clinical guidelines and procedures. - Determines the appropriateness of the design with respect to the objectives of the study and the development of the drugs or devices. - Supervises the review and evaluation of clinical data submitted in marketing applications. Evaluates reports of clinical trials in humans for evidence of safety and effectiveness. Qualifications: Must be a U.S. Citizen with Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent degree from a school in the United States or Canada. – OR – A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG). Applicants must also possess a current, active, full, and unrestricted license or registration as a Physician from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. Location: FDA White Oak Campus in Silver Spring, Maryland Salary: Starting at $180,000 and is set to commensurate with education and experience.

About the Employer

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.

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), 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 Branch Chiefs” in the subject line to: CBERHumanCapital@fda.hhs.gov. View full vacancy announcement here: https://www.fda.gov/media/157155/download

Contact Information

CBER Human Capital
10903 New Hampshire Ave
Silver Spring, MD 20993 USA
CBERHumanCapital@fda.hhs.gov

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