FDA Wants YOU! - Applied Clinical Trials

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FDA Wants YOU!

Source: Applied Clinical Trials

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and Center leaders are looking for experienced industry managers to help rebuild its staff.  Many experienced FDAers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment” of the agency,” explains Richard Moscicki, Deputy Director for Science Operations at CDER, who is leading its executive recruitment campaign. Moscicki formerly headed clinical development at Genzyme before coming to FDA in February 2013, and hopes to attract more people with similar backgrounds to public service. While some positions may be filled by internal candidates, Moscicki is looking to bring in people with leadership and management experience that may not exist at the agency.

The top jobs require advanced degrees and are most likely to come from the R&D side of biopharmaceutical companies. MDs are wanted to head the Office of Medical Policy (OMP), the Office of Generic Drugs (OGD) and for a second deputy director for the Office of New Drugs (OND).  OMP, which oversees the Office of Prescription Drug Promotion and a number of key agency initiatives, has been looking for a new leader since the January departure of long-time CDER staffer Rachel Sherman. OGD requires “someone who understands medicine, and also has the ability to drive managerial efficiency” to meet extensive new user fee goals, Moscicki noted. OND plans to add another deputy director to take on operational and quality management assignments, plus several deputy directors for individual drug evaluation offices.

Lawyers well versed in food and drug law are the likely candidates to head of CDER’s Office of Regulatory Policy, rudderless since the departure of Jane Axelrad earlier this year, and Office of Compliance, which lost Howard Sklamberg to the larger job of heading up FDA global regulatory operations. And the Office of Pharmaceutical Science (OPS) is looking for PhDs with pharmaceutical science experience to serve as director and deputy director, following the departure of Keith Webber last September. Compliance and OPS face major organizational changes under the plan to form a new Office of Pharmaceutical Quality. But Moscicki believes that the opportunity to help shape the new operation makes this “a great time” to join the agency.

FDA admittedly has to overcome a number of obstacles to recruiting experienced industry executives. The pay is low (not much above $250,000 even for top jobs) compared to the private sector. Financial disclosure is necessary, along with the divestiture of stocks in regulated companies that the individual could influence. And the hiring process can take months – something that Moscicki’s “blue-ribbon” recruitment team hopes to speed up to avoid losing attractive candidates to competing offers. FDA is limited in its ability to use executive recruiters due to cost and contracting issues, and the usual federal jobs postings are not reaching people with the managerial experience and drug regulatory knowledge that FDA wants. Thus CDER has launched this concerted effort to reach out to industry. “Yes, there are bureaucratic issues and the salary scale is lower,” but individuals gain the opportunity “to contribute to broader issues of health care and medicine,” Moscicki observes. Anyone interested in learning more should send a resume or CV to CDERExecutiveRecruitment@fda.hhs.gov.

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