Position 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 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.

Major Performance Objectives (MPOs):

Lead the Development and Implementation of Epidemiological Studies

1. Objective: Within the first 12 months, spearhead the design, development, and execution of at least two significant epidemiological studies or surveillance systems that support the strategic goals of the CDRH.
2. Measures of Success: Successful completion and launch of these studies, including the establishment of robust study designs, methodologies, and data analysis plans. Meeting key project milestones on schedule and within budget.

Enhance Real-World Evidence (RWE) Methodologies

1. Objective: Within the first 9 months, collaborate with internal teams and external partners to create and implement innovative RWE methodologies and infrastructure to support the assessment of medical device safety and efficacy.
2. Measures of Success: Introduction and validation of at least two new RWE methodologies. Positive feedback from stakeholders and evidence of enhanced regulatory decision-making processes.

Strengthen Stakeholder Partnerships

1. Objective: In the first 6 months, establish and solidify partnerships with key external stakeholders including medical device manufacturers, hospitals, academic institutions, and patient advocacy groups to enhance collaboration and data sharing for regulatory science.
2. Measures of Success: Formalized agreements or partnerships with at least three new organizations. Increased engagement and successful collaborative projects or initiatives.

Promote Equal Employment Opportunity (EEO) and Affirmative Action

1. Objective: Continuously foster an inclusive workplace by taking proactive steps to assure the accomplishment of affirmative action objectives and by adhering to non-discriminatory practices in recruitment, hiring, promotion, and employee development.
2. Measures of Success: Implementation of initiatives that promote EEO and affirmative action. Demonstrated fair treatment of all employees and recognition of their achievements, ensuring the career development and full utilization of their skills. Regular monitoring and reporting on EEO metrics and outcomes.

Critical Subtasks and Key Performance Indicators (KPIs):

Operational Audit and Assessment

1. Objective: Conduct a thorough operational audit of the division's current epidemiological study and RWE processes within the first 60 days.
2. Measures of Success: Identification and documentation of process strengths, weaknesses, and opportunities for improvement. Presentation of a detailed audit report with actionable recommendations.

Collaboration and Cross-Functional Integration

1. Objective: Foster strong cross-functional relationships within the CDRH and other FDA offices to ensure alignment and integration of epidemiological efforts.
2. Measures of Success: Regular, documented meetings and collaborative projects with at least two other departments or offices. Demonstrated alignment of goals and strategies across functions.

Project Management for Major Initiatives

1. Objective: Lead the project management efforts for one major initiative involving the implementation of new regulatory science methodologies or safety protocols within the first year.
2. Measures of Success: Successful project completion within specified timelines and budget. Achievement of project deliverables and positive stakeholder feedback.

Long-term Strategic Planning

1. Objective: Develop and lead a long-term strategic initiative to enhance the division’s capacity in real-world evidence generation and analysis over the next 3 years.
2. Measures of Success: Development of a strategic plan with clearly defined goals, timelines, and resource requirements. Initial implementation and measurable progress within the first year.

Crisis Management and Problem Resolution

1. Objective: Effectively manage and resolve any major unexpected problems or crises related to epidemiological studies or RWE activities.
2. Measures of Success: Swift identification and resolution of issues with minimal disruption to ongoing projects. Documentation of problem-solving steps and outcomes.