Develop and execute comprehensive CDx strategies aligned with corporate clinical development business objectives
Lead and drive efforts to identify and validate diagnostic biomarkers, utilizing advanced technologies like genomics, proteomics, and molecular diagnostics
Establish and manage collaborations with diagnostic partners, technology providers, labs, and stakeholders for successful diagnostic implementation
Oversee regulatory compliance, collaborate on clinical trial design, and ensure successful execution of CDx strategy.
Qualifications:
PhD, MD, or equivalent in medical related disciplines
Track record in CDx strategies development and execution in biopharmaceutical industry, prior ADC therapy advantageous
Good understanding of biomarker discovery, diagnostic tech, and clinical trial design
Well-versed in regulatory guidelines for companion diagnostics
Strong leadership, problem-solving and communications skills