Food and Drug Administration

Center for Biologics Evaluation & Research

Office of Blood Research and Review

Division of Hematology Clinical Review

Medical Officer

The FDA’s Center for Biologics Evaluation and Research, Office of Blood Research and Review, Division of Hematology Clinical Review, Clinical Review Branch (CRB) seeks a Medical Officer with a background in adult hematology to serve as a clinical reviewer of product applications. The CRB is responsible for the clinical review of blood-derived medical products and their recombinant or transgenic analogues used in a broad range of common and rare diseases.   Applicants should have knowledge of clinical trial design. Examples of products reviewed by the CRB include: coagulation factors (including prothrombin complex concentrates), anticoagulation factors, oral anticoagulant reversal agents, novel blood components, immune globulins, c-1 esterase inhibitors, alpha-1 protease inhibitors, hemoglobin based oxygen carriers, heme-based products, fibrin sealants, and volume expanders. The reviewer will analyze clinical studies and recommend whether biologic products are safe and effective for human use. In addition, the incumbent will have the responsibility for the review of clinical trial design.  This is an outstanding opportunity to work in an Office that is supported by cutting edge research. The successful candidate will participate in the FDA’s mission of advancing and protecting public health. The position also offers opportunity for advancement.

Specifics related to the position include the opportunity to:

Work with sponsors on clinical trial design

Coordinate critical and timely reviews of Investigational New Drug Applications; Biologics License Applications; New Drug Applications, and device Premarket Applications/Premarket Notifications

Present reviews at meetings within CBER, with sponsors, and with Advisory Committees;

Participate in the preparation of guidance and policy documents;

Represent FDA at local, state, national and international meetings

Participate in FDA-sponsored public workshops.

Qualifications: 

Must be a U.S. Citizen with a Doctor of Medicine or Doctor of Osteopathy from a school in the United States or Canada approved by a recognized accrediting body in the year of the applicant's graduation. [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 permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG) (or a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country).] Education completed in foreign colleges or universities may be used to meet the above requirements if you can show that the foreign education is comparable to that received in an accredited educational institution in the United States. It is your responsibility to provide such evidence when applying. This position may also be filled by appointment in the U.S. Public Health Service, Commissioned Corps. 

Candidates must possess a valid license to practice medicine in any state in the U.S.

Salary:

Salary is equivalent to GP-602-14/15 plus physician market pay (Title 38). Salary is commensurate with education and experience.  An excellent benefits package is also available.

Location: Silver Spring, Maryland

How to Apply: Submit electronic resume or curriculum vitae with cover letter to: CBER.Employment@fda.hhs.gov. Please reference Job Code: CRB-2014-1

This position may be subject to strict prohibited financial interest regulations for the employee, the spouse, and minor children of the employee.  The applicant may be required to contact the FDA Ethics and Integrity Staff to discuss these regulations and file a Confidential Financial Disclosure Report (OGE 450) which this position may have, and/or limit the ability of the employee to perform certain official functions.  Until the FDA Ethics and Integrity staff clear the selectee for this position, a final offer letter may not be granted.

The Department of Health and Human Services is an equal opportunity employer 

with a smoke free environment.