About This Role
This role involves serving as an expert senior toxicologist on a multi-disciplinary scientific and medical team. You will evaluate and decide on the approvability of regulatory submissions and applications requesting FDA regulatory consideration in specialist areas such as clinical research, testing, and manufacture of human drugs.
Responsibilities
- Serve as an expert senior toxicologist on a multi-disciplinary scientific/medical team that reviews, evaluates, and decides on the approvability of regulatory submissions and applications that request FDA regulatory consideration for specialist areas such as clinical research, testing, and manufacture of human drugs, or any other related regulatory submission to FDA
- Evaluate animal toxicological and adverse human clinical events reported by a variety of complex industry applications and post-market reports
- Maintain professional knowledge and understanding of toxicology research and testing methods as well as having a clear understanding of complex drug interactions and mechanism of actions
- Serve as CDER resources for information on current concepts in toxicology and pharmacology
Requirements
- Successful completion of a full four-year course of study at an accredited college or university leading to a bachelor's or higher degree in toxicology; or an appropriate discipline of the biological, medical, or veterinary sciences that included at least 30 semester hours in chemistry, biochemistry, or physiology, and 12 semester hours in toxicology
- One year of specialized experience, equivalent to the GS-13 in the Federal service, that includes evaluating and conducting toxicology studies; conducting research into the basic of toxicological and the development of assessments that address clinical and safety data from the pre and post marketing periods; and creating databases of toxicological and the adverse human effects of chemicals
- Submission of an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned if claiming education as any part of your qualifications
- If using education completed in foreign colleges or universities, provide evidence that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program
