Director, ECD Development

Natera seeks a Director of Development to lead the design control, verification, and validation of early cancer detection NGS-based in vitro diagnostic devices. The role oversees technical strategy, analytical performance execution, and FDA Class III PMA submissions while building and managing a cross-functional scientific team.

Responsibilities

• Execute technical strategy and phase-gated development, verification, and validation studies for ECD IVD devices
• Own analytical performance strategy including limit of detection, precision, linearity, and stability across assays
• Partner with regulatory, biostatistics, and clinical teams on statistical analysis plans and clinical study design
• Serve as technical subject matter expert in FDA interactions and correspondence
• Build, develop, and retain high-performing scientific and management teams

Requirements

• Advanced degree (PhD, MD, or equivalent) in molecular biology, biomedical engineering, life sciences, or related field
• 6+ years IVD or diagnostic device development experience under design controls
• 5+ years directing scientific or technical teams
• Deep expertise with NGS-based diagnostic assays, analytical validation, and commercial laboratory transfer
• Direct FDA interaction experience for molecular diagnostic or NGS-based devices
• Experience in liquid biopsy or cfDNA-based oncology diagnostics for low-abundance signal detection