Associate Director Duties

  • Serves as the principal scientific advisor to the Division Director, Office Director, and other Center managers with regard to post market evaluation and surveillance approaches regarding important drug safety issues.
  • Provides epidemiological expertise, consultation, and expert advice on the post market evaluation and surveillance of drugs.
  • Plans and develops activities, polices, and procedures involving interpretation and adaptation of program and policy objectives e.g. the development of the Outline Process for Epidemiology New assignments (OPENa) document and the Standards for Data Management and Analytic Processes (SDMAP) MaPP.
  • Provides critical leadership to the development of standards, processes, and good epidemiological and research practices to foster a high quality science-based epidemiological program evaluating drug safety concerns.
  • Serves as an authority on the epidemiological assessment of complex drug safety-related concerns to DEPI staff and OSE Divisions and other CDER programs. Issues reports on scientific findings to government and regulated industry.
  • Helps develop short and long term vision, priorities and plans to strengthen the epidemiology program including staff development and training, and improving computational infrastructure, analytic tools and database access.
  • Leads strategic planning of the Division to meet its mission’s needs
  • Leads or serves, as needed, as a member of Division task forces and study groups called to consider problems or directions in the areas of medical science and epidemiology. As required, conceives of the mission for such groups, develops propositions for study and represents the Division, the Office, and/or the Center on matters in the area of medical science and epidemiology.
  • Assists in the review and clearance of internal epidemiology reviews, manuscripts, papers, abstracts, and presentations intended for publication in scientific journals.
  • Represents the Division or the Office at relevant Advisory Committee meetings, Task Forces, Work Groups and national and international meetings as needed.
  • Participates in updating and implementing succession plans for current and future staffing needs.
  • Severs as a Project Officer for extramural research contracts.