Deputy Super Office Director for Drug Safety
The Office of New Drugs (OND) is recruiting to fill the position of Deputy Director for Safety (DDS).
OND ensures that safe and effective drugs and biologics are available to the American people. OND provides regulatory oversight for investigational studies during drug development, makes decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products, and provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.
The DDS for OND has primary responsibility for the implementation and management of all post-market (PM) drug safety programs and activities within OND. The role requires the individual (1) to supervise and coordinate all PM safety management conducted by the clinical office and divisional-level PM safety staff (e.g., Divisional Deputy Director’s for Safety and safety regulatory project managers, and with other clinical staff involved in PM safety drug management), assuring consistency with statute and regulations and established policy and procedures, timeliness of PM safety management decisions, and quality of decision-making consistent with the highest clinical/scientific rigor, (2) to integrate OND PM safety management efforts with those of other Center for Drug Evaluation and Research (CDER) offices involved in PM safety (including with Office of Surveillance and Epidemiology, Office of Pharmaceutical Quality, and the Office of Generic Drugs, Office of Compliance) and with PM drug safety project management and the Drug Risk Management Board in the Center Director’s office, serving in a liaison function, as appropriate; and (3) to have OND-level responsibility for advancing and developing PM safety policies, procedures, and structures (e.g., Drug Safety Teams) according to evolving knowledge, principles, and capabilities for PM drug safety; in this capacity, will work closely with the OND Policy Office and other policy offices in CDER (and FDA), with the Safety Policy and Research Team, and with the OND research program in the Office of Drug Evaluation Sciences.
As the DDS for OND, the incumbent provides technical and administrative direction and leadership to subordinate employees within the organization involved in the complex task of regulating and evaluating new drugs and biological products. The DDS for OND acts with full authority in carrying out the variety of day-to-day operations of the PM drug safety program including understanding all projects underway and an intimate understanding of major policy issues. The DDS for OND will be an innovator who seeks to improve PM drug safety and will have the ability to greatly impact within the broader CDER organization. The selected candidate will possess extensive pharmaceutical industry experience and has a proven record of leading an organization. Candidates must have a Doctor of Medicine or Doctor of Osteopathy degree from an accredited medical school. Graduates of foreign medical school must be certified by the Education Commission for Foreign Medical Graduates. Candidates must be U.S. citizens.
Interested candidates may direct questions concerning the position to the OND External Recruitment Team at firstname.lastname@example.org. To apply, submit your cover letter and CV/resume to email@example.com. Please indicate that you are applying to source code: 20-072EG.