Director of Companion Diagnostics

Job Summary

Providing strategic and operational leadership, the full-time Director of Companion Diagnostics will manage the planning, development, validation, and execution of companion diagnostic assays for oncology projects in a hybrid work environment.

Key responsibilities:

• Lead the development of CDx strategy for oncology programs, ensuring alignment with clinical development and regulatory approvals
• Provide strategic guidance and drive cross-functional alignment for programs requiring predictive biomarkers
• Oversee external diagnostic partnerships, including performance oversight, risk management, and budget accountability

Required qualifications:

• Bachelor's degree in Biological Sciences, Bioengineering, or a related field, with a minimum of 10 years of experience in diagnostics or pharmaceuticals
• Seven or more years of experience in project management or related leadership roles
• Experience in oncology drug development and biomarker-based patient selection strategies
• Working knowledge of CDx development processes and global regulatory interactions
• Advanced proficiency with Microsoft Project or enterprise planning platforms