Chief Medical Officer

About This Role

Serve as the senior medical and scientific authority for a diagnostics-focused CRO, supporting complex IVD clinical trials. This strategic role involves medical oversight, regulatory leadership, and driving scientific integrity and growth.

Responsibilities

• Serve as Principal Investigator for IVD validation trials
• Provide medical oversight across national physician study sites
• Ensure scientific integrity and regulatory compliance across all trials
• Review and approve protocols, study designs, and validation strategies
• Guide inclusion and exclusion criteria, endpoints, and clinical relevance
• Act as senior medical signatory where applicable, interfacing with regulatory bodies like the FDA
• Support business development by shaping scientifically sound proposals and advising on differentiation strategy
• Represent the company at scientific and industry conferences, building relationships with key opinion leaders
• Contribute to whitepapers and thought leadership initiatives
• Identify trends in diagnostics and precision medicine that influence company growth

Requirements

• MD required
• Strong experience in In Vitro Diagnostics
• Experience serving as Principal Investigator in clinical validation studies
• Deep knowledge of assay validation and clinical study design
• CRO and diagnostics experience required
• Experience interacting with FDA and regulatory agencies
• Familiarity with CLIA high-complexity laboratories

Qualifications

• MD

Nice to Have

• California experience preferred
• On-site presence strongly preferred