Clinical Reviewer Position - 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)

Become a part of an agency that touches the lives of every American!

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 Physician positions. Apply today for this exciting career opportunity for qualified candidates with interest in the drug development, review of clinical trials, and critical interpretation of study design and clinical data analysis.

Physicians provide clinical review and recommend appropriate actions on Investigational New Drug Applications, Biological License Applications, New Drug Applications, Investigational Drug Exemptions, Pre-Market Approvals, and Pre-Market Notifications 510(k) and other regulatory submissions pertinent to products within OTAT’s purview.

If you specialize in

Family Practice, Pediatrics, Internal Medicine or

Pediatric or Internal Medicine or Surgical subspecialties or

Sports Medicine, Orthopedics, or Physical Medicine and Rehabilitation,

we are looking for you.

What Does CBER Have to Offer You?

CBER is committed to facilitating the development of new biological products, to include but not limited to cell and gene therapies, plasma protein therapeutics, and select medical devices for a broad range of complex and often times life-threatening diseases as well as rare diseases. By joining CBER, you will fuel your own passions and use your many talents, skills, and experiences to help CBER successfully navigate the challenges and opportunities of 21st Century medicine. This position is excellent for a physician who is ready to transition into non-clinical work with an interest in drug development, review of clinical trials, and critical interpretation of study design and clinical data analysis.

Responsibilities: As a Physician within DCEPT, you will have the opportunity to:

• Review clinical trial protocols, clinical study reports, and product development plans and will participate in medical review of adverse event reports and monitoring of incoming safety data.
• Represent the agency at meetings with academic and industry sponsors and at medical conferences.

Qualifications: Physician, GP-0602: Must be a 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. The degree must have been approved by a recognized accrediting body at the time the degree was obtained.

A Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States may be demonstrated by the Educational Commission for Foreign Medical Graduates (external link), or a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country. Candidates for Civil Service or U.S. Commissioned Corps must possess a valid license to practice medicine in any state in the U.S. It is highly desired that the prospective candidate has eligible Board Certification.

Licensure: Applicant must 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.

Salary: Salary is equivalent to GS-0602-14, plus physician market pay (Title 38), and is commensurate with education/experience. U.S. Public Health Service Commissioned Corps Officers may also apply.

Location: FDA White Oak Campus in Silver Spring, MD

How to Apply: If you’re seeking a challenging and rewarding career opportunity, we invite you to apply today by completing the following steps:

1. Submit your electronic resume or curriculum vitae and supporting documentation to CBER Recruitment at cber.employment@fda.hhs.gov and carbon-copy Elizabeth Hart at elizabeth.hart@fda.hhs.gov. Supporting documentation may include: bibliography, summary of research accomplishments, and names/contact information of three references. Please reference Job Code: OTAT-21-01-JAM.
2. Create/Log-in to your USAJOBS account and review the official job opportunity announcement located on USAJobs.gov at https://www.usajobs.gov/GetJob/ViewDetails/569253400. Applications MUST be received by applying to the official job opportunity announcement located in the link above.

HHS/FDA is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.