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This position in located in the Center for Drug Evaluation Research (CDER), Office of New Drugs (OND), Office of Hematology & Oncology Products (OHOP), Division of Hematology Oncology Toxicology (DHOT) located in Silver Spring, MD.
Who May Apply: This vacancy is open to current Office of New Drugs (OND) employees with competitive status only. Competitive status refers to employees who are serving on a career or career conditional appointment.
YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE).
This announcement may be used to fill multiple positions in multiple locations.
Reviews and evaluates scientific submissions focusing on non-clinical in vitro and animal data and evaluation of toxicological potential of drugs in support of proposed clinical studies or proposed dosage regimens in the labeling.
The incumbent develops comments on labeling as it pertains to animal studies and probable safety in use of the drug for the proposed indications and at the recommended dosage.
Reviews and evaluates the results of non-clinical pharmacological and toxicological studies submitted by the drug sponsor/applicant in support of INDs, NDAs, BLAs amendments, supplements and other related scientific submissions to assess the safety of the drug based on toxicity experiments conducted by the applicant.
Prepares comprehensive summaries and integrated discussions of data submitted for reivew and other available information. Submits substantive regulatory recommendations and conclusions for concurrence by the scientific supervisor.
Meets with industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within area of review, with emphasis on non-clinical studies to support clinical studies or NDA or BLAs, as well as deficiencies in animal studies.