Director of Companion Diagnostics

Job Summary

Leading the development of integrated diagnostic strategies, the full-time Director of Companion Diagnostics will execute end-to-end plans aligned with clinical development programs while collaborating with cross-functional teams in a remote setting.

Key responsibilities

• Lead the execution of CDx strategies across clinical development programs, ensuring alignment with drug development objectives
• Collaborate with research teams and external vendors to develop predictive assays and advance CDx strategies through governance bodies
• Oversee CDx development activities, ensuring timely delivery of diagnostic kits to support pharmaceutical registration and commercial launch

Required qualifications

• PhD with a minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development
• Strong scientific expertise in clinical development, biomarker strategies, and regulatory requirements for IVD and CDx products
• Hands-on knowledge of diagnostic platforms such as NGS, IHC, and FISH technologies
• Proven ability to lead complex, cross-functional programs to completion on time and within budget
• Demonstrated ability to influence and align stakeholders across development and commercial organizations