Director, Companion Diagnostics

The role

The Director for Companion Diagnostics will drive cross-functional alignment of biomarker operations, clinical development, regulatory and quality expectations with external partners. This person will lead CDx development through IVD clinical validation to support drug development milestones.

What you will do

• Align IVD and clinical milestones with IVD quality and regulatory expectations.
• Lead oversight of device and IVD partners regarding scope, timelines, budgets, and quality.
• Define device and IVD intent, user needs, and target product profiles.
• Partner with biomarker and clinical teams to ensure IVD integration into clinical studies.
• Drive analytical validation plans and clinical validation strategies.
• Support global regulatory strategy and submissions in collaboration with partners.
• Ensure compliance with applicable device standards and regulations.
• Coordinate cross-functional working groups and conduct audit preparedness.
• Oversee document review and coordinate manufacturing readiness and supply planning.

Required qualifications

• Advanced degree in relevant field (e.g., molecular biology, biomedical engineering, or related) or equivalent experience.
• 10+ years of experience in diagnostic development.
• 4+ years leading CDx or IVD programs in pharmaceutical, medical device, or diagnostic settings.
• Proven track record delivering CDx aligned to drug approvals.
• Deep understanding of diagnostic platforms (NGS, PCR, IHC, software, DHTs, etc.) and associated standards.
• Experience managing external IVD partners and complex, cross-functional programs.
• Awareness of evolving regulatory and quality expectations.

Nice to have

• RAC
• Experience in rare disease and oncology indications

About the company

Remix Therapeutics is a clinical-stage biotechnology company developing novel small molecule therapies designed to reprogram RNA processing and address disease drivers at their origin.