Senior Director Clinical Development

Job Summary

Driving the clinical aspects of late-stage clinical development studies, the full-time Senior Director Clinical Development will manage clinical study planning and execution, oversee regulatory submissions, and collaborate with cross-functional teams, with the option to work remotely or from San Diego, CA.

Key responsibilities

• Lead the planning and execution of clinical studies to advance programs through pivotal trials and regulatory submission
• Develop key clinical documents and provide medical and scientific input for study activation and conduct
• Gather and analyze clinical data to inform strategic decisions and maintain strong relationships with internal teams and external stakeholders

Required qualifications

• Undergraduate degree required; advanced degree (PhD, PharmD) in a health science field preferred
• At least 10 years of experience in biotech or pharmaceutical clinical development, with extensive oncology trial experience
• Experience leading clinical contributions to regulatory submissions and working in dynamic startup environments
• Deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
• Demonstrated ability to evaluate and present complex scientific data effectively