Director of Companion Diagnostics
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