Are you making a difference contributing to the public health and well-being of millions of Americans? Would you like to? The physicians, scientists and other dedicated professionals at the U.S. Food & Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs 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 always looking for committed individuals to help us achieve our mission.
OND’s public health mission is to protect and enhance the health of the public through the review and evaluation of scientific data submitted by pharmaceutical manufactures in support of New Drug and Investigational New Drug applications, and to determine if candidate drugs are safe and effective. The Division of Gastroenterology within the Office of Immunology and Inflammation is seeking highly qualified gastroenterologists to serve as clinical reviewers.
We are seeking individuals who are board certified or board eligible in gastroenterology and/or hepatology (adult or pediatric). We are seeking individuals who are board certified or board eligible in gastroenterology. We are particularly interested in individuals with expertise and/or interest in functional GI, motility, or pancreatic disorders; however, others are also encouraged to apply. Graduating fellows and junior faculty are encouraged to apply.
Primary responsibilities of the clinical reviewer include the following:
- Determines whether clinical trials of new drugs and therapeutic biologics in humans are soundly conceived and supported to justify human testing
- Reviews clinical protocols and provides input regarding study design
- Together with other team members, interacts with investigators and industry sponsors to guide development of drugs and therapeutic biologics
- Determines whether marketing applications should be approved 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 and other educational activities, such as 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 special topics 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; and
- 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.).
- Relocation expenses and student loan repayment may be paid to eligible candidates.
- Flexible and/or partial telework schedules available (after completion of initial training period).
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 (ECFMG). Candidates must be U.S. citizens. Permanent U.S. residents may apply for staff fellowship appointments. The candidate will interact extensively with others within FDA, academia and industry and should have excellent written and oral communication skills. Prior research experience is desired, but not required. FDA provides extensive educational programing for new Medical Officers. This includes formal training in clinical trial design and conduct, biostatistics, clinical pharmacology, toxicology, regulatory science, technical writing, and other topics of interest. Certification by or eligibility for the American Board of Internal Medicine (ABIM) in gastroenterology, or American Board of Pediatrics (ABP) in pediatric gastroenterology, is required.
FDA IS AN EQUAL OPPORTUNITY EMPLOYER WITH A SMOKE FREE ENVIRONMENT
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