Senior Vice President Oncology Development

Job Summary

Leading the clinical advancement of oncology programs, the remote Senior Vice President Oncology Development will manage clinical development strategy, global regulatory engagement, and late-stage execution, ensuring alignment between clinical strategy and regulatory expectations.

Key responsibilities

• Lead the clinical development strategy for oncology programs, focusing on cholangiocarcinoma and hepatocellular carcinoma from early development through late-stage studies
• Direct study design and execution for Phase 1-3 clinical trials, ensuring data robustness and regulatory readiness
• Serve as the clinical development lead for global regulatory interactions, collaborating with Regulatory Affairs on strategy and messaging

Required qualifications

• MD required with substantial clinical development experience in biotech or pharmaceutical industry
• 10-15+ years of clinical development experience, with a strong focus in oncology and direct experience in liver cancers preferred
• Demonstrated experience in late-stage development and regulatory submission support, including NDA and/or BLA filings
• Deep understanding of GCP, ICH, FDA, and global regulatory requirements
• Proven ability to lead multidisciplinary clinical teams and influence cross-functionally in a start-up environment