Medical Officer

Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation & Research

Office of Vaccines Research and Review

Division of Vaccines and Related Product Applications

This position is for a Medical Officer GP-0602-14/15 in the Clinical Review Branch, Division of Vaccines and Related Product Applications (DVRPA), Office of Vaccines Research and Review, Center for Biologics Evaluation and Research.

The Division of Vaccines and Related Product Applications is responsible for (i) reviewing, evaluating, and recommending appropriate action on biological submissions, primarily vaccine products for prevention of infectious diseases; and (ii) developing guidance and policy related to these products.  The products include vaccines encompassing a wide range of pediatric and adult infectious diseases of domestic and global importance.  Live biotherapeutic products  (“probiotics”) being developed for treatment of various disorders also are reviewed by this branch.

The DVRPA is responsible for clinical review and requires medical knowledge of the diseases being treated, judgment in evaluating adverse events, and understanding of clinical trail design.  The reviewer will be responsible for determining whether products are safe and effective for human use.

The Medical Officer recruited to the DVRPA will have responsibility for review of clinical trial design of vaccine products for prevention of infectious diseases, as well as clinical trials of live biotherapeutic products.  The responsibilities will include:

1. ensuring that review memos and consultation memos, including those for pre-INDS, INDs, and BLAs, are completed in a competent and timely fashion;
2. presenting summaries of reviews at internal meetings held by DVRPA/OVRR, with sponsors, and at Advisory Committee meetings;
3. interacting professionally and courteously, and communicating with clarity with colleagues in the FDA and industry;
4. participating in preparation of guidance and policy documents;
5. helping to organize workshops to resolve regulatory issues; and
6. representing the FDA at local, state, and national and international meetings.

Specialty training in any of the following will be contributory: infectious diseases, pediatrics, internal medicine, immunology, microbiology (virology and bacteriology).

In-house training and mentoring in FDA law, biostatistics, and review practices will be provided.

Qualifications:

Must be a U.S. Citizen. 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. 

GP-15 positions may be subject to peer review.

Salary Range: 

Salary is equivalent to GP-602-14/15 plus physician market pay (Title 38).  Salary is commensurate with education and experience.  Additional recruitment incentives may be available.  The Federal government offers an excellent benefits package. These positions may also be filled by appointment in the US Public Health Service, Commissioned Corps.

How to Apply:

Submit electronic resume or curriculum vitae with cover letter to: CBER.Employment@fda.hhs.gov by November 30, 2009.  Please reference Job Code: Sun.

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