Sr. Medical Director, Clinical Development (GU Cancer/Prostate Renal)

Role Summary

The Senior Medical Director - Clinical Development (GU Cancer/Prostate Renal) leads the clinical development of targeted radiopharmaceuticals for treatment of solid tumors, focusing on GU cancers. Provides medical direction and scientific/clinical expertise to guide RayzeBio's GU cancer clinical development plans, including IND support, regulatory interactions, and Phase 1–3 trials, with medical monitoring. Based onsite in San Diego, CA or Lawrenceville, NJ.

Responsibilities

• Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
• Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies
• Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents
• Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators
• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
• Translate findings from research and nonclinical studies into clinical development opportunities
• Oversee Data Review and Independent Data Monitoring Committees
• Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
• Establish and maintain positive relationships with clinical trial investigators and thought leaders
• Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings
• Supervise and mentor clinical scientists and medical directors
• Willing to travel approximately 30% of the time

Education

• MD or equivalent with sub-specialty training in oncology and at least 8 years of pharmaceutical/biotech in oncology solid tumor clinical development or equivalent academic experience. Radiopharmaceutical experience is preferred but not required.
• Drug development experience in GU cancer required.

Skills

• Patient-focused, with deep commitment to understanding needs and improving lives of patients with cancers
• Ability to work in fast-paced, high-accountability environment; leads through influence and interpersonal skills
• Strong task prioritization and ability to deliver on deadlines with high standards
• Collaborates effectively with multiple functions in a team
• Intellectually curious with courage to challenge and improve processes
• Strong written and oral communication, including presentations
• Ability to analyze and interpret data and present findings
• Strong critical, strategic, and analytical thinking
• Experience with protocol conduct across early and late phases, including start-up, execution, analysis, and reporting
• Experience working with investigative sites and trial personnel
• Skilled in clinical research and drug development/approval processes
• Ability to function in a highly regulated environment and adhere to RayzeBio SOPs
• Solid understanding of GCP and ICH guidelines

Education

• Not specified beyond the above; education section repeated for emphasis