Director of Companion Diagnostics Development - Remote

Overview

The Director of Companion Diagnostics Development will lead the development and execution of diagnostic strategies aligned with clinical programs, focusing on precision medicine to fight cancer.

In Short

• Lead integrated CDx strategies for clinical development programs.
• Engage with research teams to understand biomarker strategies.
• Collaborate on developing predictive assays with internal and external teams.
• Define and advance CDx strategies through governance bodies.
• Work with Regulatory Affairs on documentation and submissions.
• Oversee CDx development activities for timely delivery of diagnostic kits.
• Communicate program progress and risks to stakeholders.
• Monitor industry trends and regulatory requirements.
• Contribute to training and management activities.

Requirements

• PhD with 5+ years in clinical biomarker testing and CDx development.
• Strong expertise in clinical development and regulatory requirements.
• Hands-on knowledge of diagnostic platforms like NGS and IHC.
• Ability to lead complex cross-functional programs.
• Strong analytical and strategic thinking skills.
• Excellent communication skills for diverse audiences.
• Experience in a matrixed environment.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision.
• 401(k) with company contributions.
• Paid Time Off and Wellness programs.
• Equity awards and Employee Stock Purchase Plan.
• Participation in annual bonus or incentive compensation plans.