Deputy Director for Science, Office of Translational Science, FDA

FDA's Center for Drug Evaluation and Research (CDER) is conducting a nationwide search for a talented leader to join the Office of Translational Sciences (OTS) as the Deputy Director for Science.

The Office of Translational Sciences (OTS) has over 500 employees. OTS promotes and protects public health by assuring that safe and effective drugs are available to Americans by:

• Promoting innovation in drug regulatory review across CDER
• Assuring the validity of clinical trial design and analysis in regulatory decision making
• Developing and applying quantitative and statistical approaches to decision making in the regulatory review process
• Promoting scientific collaboration to advance regulatory review
• Ensuring alignment of CDER research with CDER goals

This unique, dynamic, and impactful position supports the Office Director and represents the Center's top management in scientific and regulatory matters. The Deputy Director for Science provides direction, coordination, and leadership to the OTS science and research staff, coordinates and oversees CDER research activities, including research in human subjects, the Regulatory Science Research Enhancement (RSR) program, and CDER Critical Path Initiatives. The Deputy Director for Science promotes the development and implementation of CDER-wide processes to identify science needs, set scientific priorities, establish policy, develop tools to track, manage, and report on science activities, review the quality and outcomes of CDER science programs, and manage competitive intramural funding programs. This critical position supports the Center Director in developing responses to queries from various stakeholders, including FDA, DHHS, OPM, and Congress ,related to CDER’s regulatory science programs, projects, and outcomes.

The Deputy Director for Science serves as a full deputy with full delegated authority in the absence of the Director. This position supervises a staff of scientists and project managers; participates fully in overall management of the OTS with emphasis on science matters and administration of science and research programs; and advises or exercises a strong influence on the formulation of basic policy directives that form the framework for management of Office and Center science programs.

The competitive candidate must be an excellent communicator, have a commitment to the highest standards of public service; be a proponent of innovation in translational sciences; have a broad understanding of regulatory science;have 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; have an understanding of Federal Regulations related to the work of CDER; and the proven ability to provide strong leadership and innovative thinking to promote the maximum potential of a large organization with a multicultural workforce.

FDA and CDER headquarters are located in Silver Spring, Maryland, on the beautiful White Oak Campus. CDER is responsible for the regulation of over-the-counter and prescription drugs, including biological therapeutics and generic drugs. Additional information about CDER’s work, organizational structure can be found here: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/default.htm

At a minimum, the candidate must possess a doctoral-level degree from an accredited institution of higher learning, including: PhD, MD, DVM, DDS, DMD, ScD, or other research doctoral degree widely recognized in US academia as equivalent to a PhD.

If you are interested in applying for this position, please submit your resume or curriculum vitae, including any experience, training, and skills which have prepared you for this assignment, a copy of your transcript and any publications to: CDERExecutiveRecruitment@fda.hhs.gov">CDERExecutiveRecruitment@fda.hhs.gov