Tech Stack

Description

You will define and lead the global regulatory diagnostic strategy for Revolution Medicines' oncology pipeline, ensuring synchronized drug-diagnostic co-development from discovery through registration and launch across US, EU, and Asia-Pacific markets. You will build and manage a high-performing regulatory CDx organization and serve as a strategic partner to clinical development and commercial teams.

Requirements

• Advanced degree in Molecular Biology, Pathology, Genetics, or related discipline
• 12+ years in pharma, biotech, or diagnostics; 10+ years leading CDx or biomarker-driven programs
• Demonstrated success leading FDA and global CDx regulatory submissions (PMA/IDE, IVDR)
• Deep expertise in NGS and PCR technologies, biomarker validation, and oncology
• Proven ability to lead matrixed organizations and drive alignment across stakeholders

Responsibilities

• Define and execute global companion diagnostic regulatory strategy aligned with precision oncology pipeline
• Ensure early integration of biomarker and CDx strategies into clinical development programs
• Build and lead a high-performing global regulatory CDx organization
• Manage global regulatory CDx operating budget
• Develop global regulatory strategies for CDx with FDA, EU IVDR, PMDA, and other authorities