Director of Companion Diagnostics

Job Summary

A company is looking for a Director of CDx Development.

Key Responsibilities

• Lead the development and execution of integrated CDx strategies across clinical development programs
• Collaborate with internal and external teams to develop predictive assays and define Diagnostic Target Product Profiles
• Oversee CDx development activities and ensure timely delivery of diagnostic kits for pharmaceutical registration and launch

Required Qualifications

• PhD with a minimum of 5+ years of experience in clinical biomarker testing and companion diagnostics development
• Strong scientific and technical expertise in clinical development and regulatory requirements for IVD and CDx products
• Hands-on knowledge of diagnostic platforms such as NGS, IHC, and FISH
• Proven ability to lead complex, cross-functional programs to completion on time and within budget
• Experience working effectively in a matrixed environment and leading cross-functional teams