Deputy Division Director

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

Introduction

The U.S. Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

The mission of the Center for Devices and Radiological Health (CDRH or Center) is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. The Office of Product Evaluation and Quality (OPEQ) assures patients have access to high quality, safe, and effective medical devices and products throughout the total product lifecycle (TPLC) by implementing program areas through which medical devices are evaluated or cleared for clinical investigations and marketing. The Office of Clinical Evidence and Analysis’ (OCEA or Office) Division of Clinical Science and Outreach (DCEA3) is responsible for epidemiological and real-world evidence infrastructure development, epidemiologic study design, methodology, and data analysis, as well as outreach and collaboration with external stakeholders including hospitals and clinical researchers. As the Deputy Division Director, the incumbent serves under the direction of the DCEA3 Director, regarding matters of general policy, program objectives and priorities, project resource allocations, and budget limitations.

Duties/Responsibilities As a Deputy Division Director of OCEA/DCEA3, the selected candidate will support the DCEA 3 Director by: • Directing the design, development, coordination, implementation, and management of complex public health epidemiological studies and surveillance systems to ensure programmatic and project goals and objectives are consistent, compatible, and complementary with mission of the Office and Center. • Directing and measuring the effects and quality of all aspects of activities under FDA’s national Medical Product Safety Network, MedSun, and incorporate the clinical community’s perspective into the regulatory and patient-safety work of FDA. • Drafting recommendations, most of which will be technical in nature, to describe real-world evidence activities, analysis, results, and conclusions to assist in regulatory decision-making. • Coordinating and collaborating with stakeholders on the development of infrastructure novel methodology for generating real-world evidence. • Directing the epidemiologic analysis and interpretation for real-world studies. • Ensuring the safety of marketed devices through overseeing the development of methods for post-market surveillance and conduct of real-world evidence based post-market safety studies. • Communicating data findings to Office leadership and stakeholders using different visual formats and graphic displays to share meaningful presentations of data and provide reports. • Forging mutually beneficial formal partnerships with medical device manufacturers, foreign agencies, professional scientific organizations, health care community, patient advocacy groups, academia, and other federal, state, and local stakeholders. • Creating and sustaining a strong and dynamic culture within the Division including organizational agility, a focus on continuous improvement, and staff empowerment and collaboration. • Providing subject matter expertise and regulatory support in the form of consultation in the reviews of new medical devices and accompanying test data and reports.

How to Apply Submit resume or curriculum vitae, transcripts with cover letter by October 12, 2023 to CDRHRecruitment@fda.hhs.gov. Compile all applicant documents into one combined document (i.e., Adobe PDF). Candidate resumes may be shared with hiring official within the CDRH with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please include the following Job Reference ID in the subject line of your email submission: DCEA3 Deputy Division Director

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.

Announcement Contact For questions regarding this Cures position, please contact CDRHRecruitment@fda.hhs.gov.

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.