Associate Director for Medicine (Chief Medical Officer)

Associate Director for Medicine (Chief Medical Officer)

Quick Facts

• Executive medical leadership for FDA’s biological product medicine programs
• Focus on medical program operations, regulatory medical review quality, clinical guidance, and public health priorities
• Requires Top-Secret security clearance and compliance with drug-testing requirements

Description

The Associate Director for Medicine serves as the Center’s chief medical leader, evaluating medical program needs and executing strategic improvements through subordinate leadership. The role oversees medical business operations, provides expert guidance on biologics controversies and compliance risk, and advises senior FDA leadership and external stakeholders. The position also develops clinical guidelines and helps ensure budgets and user fee commitments align with Center priorities.

Responsibilities

• Evaluate Center medical program needs and identify improvement opportunities; execute strategic change
• Oversee Center medical business operations (regulatory project management, resource capacity planning, hiring, and talent development)
• Review annual and ad-hoc budget requests and recommend funding based on trade-off analysis and Center priorities
• Ensure user fee commitments are met with FDA partners; build and maintain stakeholder relationships
• Advise the Center Director, Deputy Director, and senior FDA officials on Center-wide medical activities and public health priorities
• Resolve biological product controversies; make hazard and risk classification decisions for product problems and recalls
• Develop and negotiate biologics approval criteria with other agencies
• Oversee quality and consistency of Center-wide medical review processes; provide coordination to key officials
• Develop clinical guidelines for biologicals related to INDs, BLAs, IDEs, and PMAs; provide authoritative medical risk assessments
• Identify and correct weaknesses in Center medical programs; eliminate duplication and optimize resources across agencies
• Establish policy and program objectives aligned with organizational and government goals; keep leadership informed
• Represent the Center Director in complex medical/scientific meetings and present FDA’s position on biologics
• Provide expert consultation across FDA, represent FDA at professional meetings, and prepare Congressional testimony
• Perform other assigned duties

Requirements

• U.S. citizenship or proof of being a U.S. National by the closing date
• Career or career-conditional appointment within the competitive service
• Top-Secret security clearance and completion of required background investigation
• Negative pre-appointment urinalysis drug test; subject to random/reasonable suspicion/post-accident testing
• Ethics clearance and financial disclosure (SF-278) required
• Executive leadership experience in biologics or drug development and management of significant organizations and budgets
• Effective written communication for policy/guidance and Congressional inquiry responses
• Effective oral communication to communicate Center/Agency policies for biological product development
• Submit required education transcripts demonstrating eligibility

Benefits

A comprehensive federal benefits package is available. Eligibility depends on the position type and is determined by the hiring agency.