Define and lead the end-to-end global regulatory diagnostic strategy for the company’s portfolio
Job Summary
Define and lead the end-to-end global regulatory diagnostic strategy for the company’s portfolio.
Ensure companion diagnostics are fully integrated into clinical development plans with no downstream regulatory surprises.
Build and lead a high-performing global regulatory CDx organization, fostering a culture of scientific rigor, accountability, collaboration, and execution excellence.
Matching Summary
Define and lead the end-to-end global regulatory diagnostic strategy for the company’s portfolio.
Salary
$211,000—$264,000 USD
Skills & Requirements
Must-have
Global regulatory diagnostic strategy
Drug-diagnostic co-development
Synchronized drug and CDx approvals
NGS and PCR technologies expertise
Biomarker validation and clinical implementation
Nice-to-have
Leadership in precision oncology CDx
Cross-functional stakeholder alignment
External network with diagnostic manufacturers
Key Requirements
12+ years experience in pharma/biotech/diagnostics
10+ years leading CDx or biomarker programs
Demonstrated success leading FDA and global CDx submissions
Advanced degree in Molecular Biology, Pathology, or Genetics