Job Overview

Summary

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

This position is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Office of Drug Evaluation 3 (ODE).  The incumbent serves on a multi-disciplinary scientific/medical team that reviews, evaluates and decides on the approvability of drug submissions and applications that request regulatory consideration. 

 

This job opportunity announcement may be used to fill additional vacancies.

Duties

  • Reviews and evaluates scientific submissions (e.g., non-clinical pharmacological and toxicological studies) to determine the toxicological potential of drugs.
  • Prepares comprehensive summaries of data submitted including regulatory recommendations for concurrence by the supervisor.
  • Applies new developments and theories to critical and novel problems regarding pharmacological/toxicological issues.
  • Provides leadership and regulatory guidance to subordinate pharmacologist.
  • Meets with industry representatives to exchange information and provide advice in support of clinical studies, New Drug Applications (NDA), or Biologic License Applications (BLA), and deficiencies in animal studies.