Careers

ADC Development Lead

Position Summary

The ADC Development Lead provides clinical leadership for multiple ADC programs including direct responsibility for clinical development strategy and execution of clinical trials. This person will independently lead multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions.  This position reports to the SVP, Head of Clinical Development.  This position is based on the Pacific Time Zone, with a preference for the San Francisco Bay Area.

Key Responsibilities

• Design robust and innovative clinical development plans for solid tumor ADCs with clinical trials spanning Phase Ia through registrational trials.
• Serve as the program lead while working in a cross functional environment with representatives from other involved line functions and lead teams towards sound decision-making.
• Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials and other clinical study related documents based on the global development plan.
• Perform medical monitoring, responses to site inquiries, and work with CRO medical monitors when appropriate.
• Interact effectively and successfully with regulatory agencies.
• Cultivate and nurture strong collaborations with key opinion leaders, investigators, CROs, research centers and corporate partners.
• Medical lead in data analysis and interpretation, reporting and communication to ensure consistency and relevance of medical content and scientific messages across Clinical Study Report, health authority briefing books, NDA/BLA submission documents, and external presentations and publications.

Education & Experience

• MD or MD/PhD with Oncology (solid tumor) or relevant clinical training.
• Minimum of 10 years of industry experience in oncology clinical development, with first-hand experience designing, executing, and interpreting first-in-human clinical trials and serving as the medical monitor.
• Minimum of 3 years operating as a clinical lead for an oncology program at a biotech/pharma organization.
• Experience with development of antibody-drug conjugates strongly preferred.
• Experience working in a small company environment.
• Ability to operate independently and work with internal team members, external development partners, and site investigators.
• Strong communication and presentation skills, with the ability to engage, influence, and build consensus across cross-functional teams, senior leadership, and external collaborators.
• Demonstrate proven knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates / products.
• Familiarity with drug-diagnostic co-development.