Clinical Reviewer

Found in: beBee S US - 2 weeks ago

Silver Spring, United States FDA - Office of New Drugs Full time

Would you like to make an outsized difference to the public health and well-being of Americans? The physicians, scientists and other dedicated professionals at the U.S. Food & Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs (OND) located in Silver Spring, MD, contribute to the public health of millions of Americans every day. We pride ourselves on our dedicated and skilled staff and are looking for committed individuals to help us achieve our mission. OND’s mission is to ensure that safe and effective drugs and biologics are available to Americans. We provide guidance to drug companies on a wide variety of clinical, scientific, and regulatory matters and make decisions on whether new drugs or new uses of already marketed drugs should be approved.

The Pharmacy Compounding Review Team within OND seeks physicians with internal medicine board certification/board eligibility (ABIM) to serve as clinical reviewers of  compounded drug products. Practicing physicians, fellows, and residents are encouraged to apply.

Primary responsibilities of the clinical reviewer include the following:

  • Assesses suitability of the bulk drug substances to be used in 503A or 503B compounded drug products, depending primarily on the type of compounder involved in producing the drug product, under the Drug Quality and Security Act (DQSA) of the Federal Food, Drug and Cosmetic Act (FD&C Act).
  • Determines whether clinical trials of drugs and biologics in humans are sound and supported to justify human testing.
  • Reviews clinical protocols and provides input regarding study design.
  • Together with other team members, interacts with investigators and drug companies to guide development of drugs and biologics.
  • Reviews publicly available scientific literature and determines whether bulk drug substances should be added to the 503A or 503B Bulks Lists  based on an evaluation of the evidence of safety and effectiveness.
  • Consults, when needed and where appropriate, with other medical specialists and scientists within and outside FDA.
  • Assists in the development and conduct of training programs, educational activities, workshops, and conferences.
  • Keeps abreast of the progress in medical and related sciences by reviewing the scientific literature and participating in staff seminars where cases and topics of interest are discussed.

    As a clinical reviewer, you will have the opportunity to:

    • Advance the public health through new drug development.
    • Experience teaching and training opportunities.
    • Interact with pharmaceutical companies, world-renowned disease experts, patients, and advocacy groups.
    • Work with a wide range of scientific disciplines in a team-oriented atmosphere

      This is primarily a non-clinical position; there is an option to provide one half-day per week of clinical care, if interested.

      SALARY & BENEFITS

    • Salary is commensurate with experience and expertise.
  • Excellent federal government benefits package (health insurance, life insurance, retirement, etc.).
Student loan repayment may be paid to eligible candidates. Flexible and telework-eligible schedules available (requires 2-days onsite in Silver Spring, MD and 8-days telecommute each 2 weeks’ pay period)

QUALIFICATIONS

Applicants must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited medical school. Graduates of foreign medical schools must be certified by the Education Commission for Foreign Medical Graduates. Excellent oral and written communication skills and an ability to work effectively in a team are necessary to be successful in this role. Experience with clinical research and scientific publications is desirable but not required.

TO APPLY

Please send a current CV/resume and cover letter to ond-employment@fda.hhs.gov for consideration. Please reference source code: #24-023EG in the subject line.

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