U.S. Licensed Senior Director Clinical Development

Job Summary

U.S. Licensed Senior Director, Clinical Development is a full-time position responsible for leading clinical development strategy and execution for immuno-oncology assets across Phase I-III, ensuring patient safety, driving regulatory interactions, and collaborating cross-functionally to deliver trials on time.

Key Responsibilities

• Lead the creation of Clinical Development Plans (CDPs) and design Phase I-III clinical trial protocols for immuno-oncology assets
• Serve as the primary Medical Monitor for assigned studies, overseeing patient safety and managing immune-related adverse events
• Act as the lead clinical representative for regulatory interactions and author key clinical sections for submissions

Required Qualifications

• M.D. or M.D./Ph.D. with specialization in Medical Oncology or Hematology/Oncology
• 7+ years of experience in clinical development within the biotech or pharmaceutical industry
• Deep knowledge of immuno-oncology therapies for oncology
• Proven ability to thrive in a fast-paced, startup environment
• Expert understanding of GCP, ICH guidelines, and global regulatory requirements