Seeking a Director, Office of Biostatistics (OB) within the Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER) located at the Food and Drug Administration (FDA) in Silver Spring, Maryland. OTS seeks a candidate fully committed to supporting FDA’s public health mission and ensuring its status as a premier regulatory agency. The Director leads one of the largest groups of biostatisticians in the world that protect and promote public health.
The Center for Drug Evaluation and Research (CDER) within the FDA is responsible for regulating prescription drugs, including new drugs and generic drugs as well as over-the-counter drugs. CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the over the counter drug monograph system; monitoring of all marketed drug safety and promotional activities; review, monitoring and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.
The Office of Biostatistics is recognized for excellence in the application and communication of statistical science in drug regulation and development. It has a central role in promoting innovative, science-based, quantitative decision-making throughout the drug development life-cycle. The Office of Biostatistics provides CDER and other internal and external stakeholders with statistical leadership, expertise, and advice to foster the expeditious development of safe and effective drugs and therapeutic biologics for the American people.
Director is expected to:
Manage the daily operations of an expansive matrix organization
Encourage innovative science in drug development and regulatory processes
Lead development of streamlined bioinformatics and computational science support for quantitative decision making
Lead efforts toward research oversight and prioritization
Foster an environment of open scientific discussion
Serve as the CDER primary point of contact for statistical activities and interactions
Promote and expand visibility for statistical science initiatives
Integrate translational scientific principles into the regulatory review process
The ideal candidate should have the following characteristics and qualifications:
A commitment to the highest standard of public service
A proponent of innovation in translational sciences
A concern for professional growth and development of scientific staff
A commitment to outreach and collaboration with internal and external stakeholders
Ability to function within a regulatory environment and problem solve to meet challenging demands
An understanding of Federal Regulations related to the work of CDER
Proven ability to provide strong leadership and promote maximum potential of a large organization with a multicultural workforce
Candidates must meet the minimum qualification requirements for the GS-15 or beyond in the civil service General Schedule and must have a strong scientific background and managerial experience.
Candidates must have a doctoral-level degree from an accredited institution of higher learning, including: Ph.D. or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph. D.;
Transcripts are a requirement to support the advanced degree.
A strong scientific background in translational sciences with a strong fundamental understanding of biostatistics and clinical medicine/therapeutics; have experience and/or knowledge of contemporary drug development; prior senior leadership experience and have excellent interpersonal skills. The candidate will also be experienced in oversight and implementation of quality systems as they apply to the life cycle of drug development.
Position level:Title 42 209(f)
Salary Range: Salary is commensurate with education and experience.
Relocation, recruitment incentive and credible service will be considered.
Divestment Information: As an incumbent, you could be required to sell all financial interests in organizations that are deemed significantly regulated by FDA unless the financial interest meets the exception and does not conflict with the duties you are hired to perform.
How to Apply: All qualified candidates can submit resume/curriculum vitae electronically and a cover letter in which you describe why you feel you are uniquely qualified for this position. Submit both documents to Whitney Flickinger, CDERExecutiveRecruitment@fda.hhs.gov.
Closing Date: January 31, 2018.
Department of Health and Human Services (DHHS)/ Food and Drug Administration (FDA) is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and
veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by h...elping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has
responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public
health and to reduce tobacco use by minors.
FDA also plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring
the security of the food supply and by fostering development of medical products to respond to deliberate and naturally
emerging public health threats.