Team Lead - Physician

Employer
Center for Biologics Evaluation and Research, FDA
Location
Silver Spring, Maryland
Salary
Commensurate with education/experience
Closing date
Oct 28, 2021

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Team Lead - Physician

Office of Tissues and Advanced Therapies (OTAT)
Center for Biologics Evaluation and Research (CBER)
Food And Drug Administration (FDA)
Department of Health and Human Services (HHS)

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies’ (OTAT) Division of Clinical Evaluations and Pharmacology/Toxicology (DCEPT) is recruiting to fill multiple positions for Team Lead - Physician in the Clinical Hematology Branch (CHB).

RESPONSIBILITIES: As the Team Lead - Physician, duties may include but are not limit to:

  • Serving as the principal advisor to the Branch Chief and the Division Director for all classes of biologic products that concern hematologic disorders.
  • Evaluating clinical data submitted to OTAT by sponsors of biologic products and advanced therapies to support Biologics License Applications (BLAs), Investigational New Drug applications (INDs), Investigational Device Exemptions (IDEs), reports of pre-and post-marking trials and studies and other related regulatory submissions.
  • Consulting other offices in CBER and other Centers at FDA on complex issues related to advanced therapies, including cell and gene therapy and other therapeutic biological products and devices.

QUALIFICATIONS: Must be U.S. citizen with Doctor of Medicine (M.D.), Doctor of Osteopathic Medicine (D.O.) or equivalent from a school in the United States or Canada. Official transcripts will be required prior to appointment. Applicants must possess 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 and 5 years of graduate-level training in the specialty of the position to be filled or equivalent experience and training.

SALARY: Salary is equivalent to GS-0602-15, plus physician market pay (Title 38), and is commensurate with education/experience.

LOCATION: Silver Spring, MD

TO LEARN MORE: If interested in learning more about this position within CBER, please express your interest in a brief explanation and submit your electronic resume or curriculum vitae to CBER Recruitment at cber.employment@fda.hhs.gov and carbon-copy both Bindu George at bindu.george@fda.hhs.gov and Tejashri Purohit-Sheth at tejashri.purohit-sheth@fda.hhs.gov. Please reference Job Code: OTAT-21-13-ACO.

DEPARTMENT OF HEALTH AND HUMAN SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER SMOKE FREE ENVIRONMENT

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