Lead Physician (Hematology)

Company/Institution: FDA/Center for Biologics Evaluation and Research
Location: Silver Spring, MD, USA
Degree Requirements: MD, DO, Board Eligible, Board Certified Salary: $150,000 - $199,999
Job Type: Research, Academic/Administrative, 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, to include training/experience in either malignant and/or nonmalignant hematologic conditions to serve as a Lead Physician in our Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT). The Lead Physician will serve as a secondary reviewer and is 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. Duties/Responsibilities: - 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 junior staff to evaluate clinical trial designs and interpret regulations and guidance regarding the standards of safety and effectiveness for products regulated by OTAT. - Lead reviews to include assigning and evaluating work of team members on a regular and recurring basis. - Perform secondary regulatory reviews 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. - Serve 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. - Serve 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. 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, copy of active medical license, copy of 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. View full vacancy announcement here: https://www.fda.gov/media/157153/download

Contact Information

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

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