FDA - Deputy Division Director Division of Clinical Evidence and Analysis 3- Epidemiologist
5 days ago
As the Deputy Division Director for the Division of Clinical Evidence & Analysis 3 (DCEA3) within the CDRH’s Office of Clinical Evidence and Analysis (OCEA), you will play a pivotal role in enhancing public health through rigorous development and management of epidemiological studies and real-world evidence (RWE) infrastructures. Under the guidance of the Division Director, you will spearhead efforts to integrate clinical community perspectives into FDA's regulatory and patient safety work. This involves substantial collaboration with external stakeholders, such as hospitals and clinical researchers. Your leadership will ensure that the division’s projects align with the strategic goals of the CDRH and contribute to the overall mission of protecting and promoting public health.
Employee Value Proposition (EVP):
This role offers a distinctive opportunity to impact public health by ensuring the safety and effectiveness of medical devices and radiation-emitting products. As the Deputy Division Director, you will lead pioneering initiatives that shape national regulatory standards and enhance patient safety. This position provides a platform for professional advancement in regulatory science and public health, offering the chance to influence policies and methodologies with far-reaching effects on healthcare and patient outcomes.
Key ResponsibilitiesFunctional 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. 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.
Additional Skills 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.
Equal Employment Opportunity (EEO) Responsibilities:As the Deputy Division Director, you will be responsible for furthering the goals of equal employment opportunity (EEO) by actively promoting affirmative action and adhering to non-discriminatory practices regarding 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.
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Silver Spring, United States AE Strategies Full timePosition Overview:As the Deputy Division Director for the Division of Clinical Evidence & Analysis 3 (DCEA3) within the CDRH’s Office of Clinical Evidence and Analysis (OCEA), you will play a pivotal role in enhancing public health through rigorous development and management of epidemiological studies and real-world evidence (RWE) infrastructures. Under...
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