Director of IVD Assay Development

A company is looking for a Director, IVD Assay Development.

Key Responsibilities

Lead the design and execution of development studies for colorectal cancer tests

Oversee Analytical Validation (AV) studies to support Premarket Approval (PMA) applications

Manage and mentor team members while ensuring alignment with regulatory standards and corporate goals

Required Qualifications

Ph.D / MS / BS in Molecular Biology, Biochemistry, Genetics, or related field

Experience in a regulated environment and with AV studies for liquid biopsy tests

Proven experience in negotiations with the FDA for AV study designs

10+ years of experience managing R&D teams in clinical diagnostics development

Hands-on experience with NGS-based molecular assay development and knowledge of CLSI guidelines