FDA - Deputy Division Director Division of Clinical Evidence and

Job Description

Description

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote public health. CDRH assures that

patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiationemitting products. CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible sciencebased information about the products we oversee. We facilitate medical device innovation by advancing regulatory science,

providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in

devices marketed in the United States.

21st Century Cures Act Eligibility: All CDRH positions directly impact and/or support the mission to assure that patients and

providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

This position reports to the Division Director.

This position is located in various locations.

Functional duties and responsibilities:

Serves as the Deputy Division Director for the Division of Clinical Evidence & Analysis 3 (DCEA3), within CDRH’s Office of Clinical

Evidence and Analysis (OCEA), Office of Product Evaluation and Quality (OPEQ). 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 Division Director regarding matters of general policy, program objectives and priorities,

project resource allocations, and budget limitations.

Cures SOD – OCEA/DCEA3 Deputy Division Director

The Deputy Director supports the the DCEA3 Director in efforts to direct and measure 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. He/she will direct 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. The incumbent will oversee

the epidemiological analysis and interpretation of real-world studies through 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. The Deputy Division Director will coordinate with stakeholders on the development of infrastructure novel methodology for

generating real-world evidence.

He/she ensures the safety of marketed devices through oversight of the development methods for post-market surveillance and

conducting real-world evidence based post-market safety studies. Communicates data findings to Office leadership stakeholders

using different visual formats and graphic displays to share meaningful presentations of data and provide reports. Forges 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.

In this role, the Deputy Director provides subject matter expertise and regulatory support in the form of consultation in the reviews

of new medical devices and accompanying test data and reports. Represents the FDA/CDRH at national scientific conferences,

multiple stakeholder committees, registries steering committees, national working groups, and/or FDA advisory panel meetings.

Supervisory responsibilities: Supervises and coordinates the work of Assistant Directors and other Division personnel involved in

multiple projects across clinical evidence areas (such as clinical investigations, bioresearch compliance, human subject protection,

clinical evidence synthesis and analysis, epidemiological methodologies and data infrastructure, and collaboration and outreach with

hospitals). Reviews work for potential impact on broad FDA/CDRH policy objectives and program goals and for contribution to the

advancement of the field. In partnership with the Division Director, leads the strategic achievement of organizational goals,

evaluating organizational performance and taking action to improve performance.

Organizational Management: Partners in managing a Division.

Program Management: Runs a functional activity. Oversees multiple projects. Identifies inputs and outputs needed to

perform functional activities.

Resource Management: Consolidates and balances resource needs of multiple projects in a functional activity or Division.

Personnel Performance Management: Counsels and rates immediate subordinates.

Human Capital Management: Identifies ways to meet employee competency goals.

Key Responsibilities

EEO responsibilities: The incumbent is responsible for furthering the goals of equal employment opportunity (EEO) by taking

positive steps to assure the accomplishment of affirmative action objectives and by adhering to non-discriminatory employee

practices in regard to race, color, religion, sex, national origin, age, disability, sexual orientation, affiliation or non-affiliation with a

labor organization, political affiliation, and status as a parent or gender identity. Specifically, as a manager, the incumbent initiates

nondiscriminatory practices and affirmative action for the Center in the following: (1) merit promotion of employees and

recruitment and hiring; (2) fair treatment of all employees; (3) encouragement and recognition of employees’ achievements; (4)

career development of employees; and (5) full utilization of their skills.

Skills, Knowledge and Expertise

Other factors.

Knowledge:

Qualifications: Advanced working knowledge of all aspects of occupational specialty. May be obtaining proficiency

in one or more aspects of other occupational specialties.

Breadth of Knowledge: Medium

Depth of Knowledge: Deep

Complexity of work:

Problem Solving: Solves problems of all complexities for a function. Identifies and prioritizes problems for a

function.

Decision Making: Consolidates multiple decisions to form a cohesive consensus.

Statement Making: Consolidates declarative results from multiple projects to form a coherent message.

Cures SOD – OCEA/DCEA3 Deputy Division Director 3

Coalition building:

Coordination: Coordinates work across projects within a discipline.

Thought Leadership: Forges relationships among professionals to spread best practices.

Impact:

Impact on Work Being Performed: Work impacts multiple projects simultaneously.

Level of Autonomy: Identifies and recommends standard procedures.

Scope of Work (Impact on Consumer): Oversees determinations of successful or unsuccessful outputs of activities.

Impact on Organization: Oversees quality of work on multiple projects.

Risk Management: Identifies risk mitigation procedures.