Director, Early Cancer Detection NGS Development

Natera, Inc.; San Carlos (CA); Remote; USD 229,000 - 286,000; Full time

Benefits offered by this job

Competitive Benefits

Free testing for employees and depend.

Pregnancy and baby bonding leave

401k benefits

Commuter benefits

Employee referral program

Job summary

Natera, Inc. is seeking a Director of Development to own the end-to-end development and regulatory strategy for our Early Cancer Detection (ECD) IVD products.

You will drive design verification and validation from feasibility through PMA submission, serving as the FDA SME and leading a team of scientists and managers. You will oversee analytical performance strategies, coordinate with Regulatory Affairs, biostatistics, and research, and ensure successful technology transfer to commercial labs

Qualifications

• Advanced degree (PhD, MD, or equivalent) or MS with relevant industry experience
• 6+ years of experience in IVD or diagnostic device development under design controls
• 5+ years directing scientific or technical teams
• Deep technical expertise with NGS-based diagnostic assays and analytical validation
• Experience with FDA interactions for molecular diagnostics or NGS devices

Responsibilities

• Own the technical strategy and phase-gated development for ECD IVD devices
• Ensure compliance with FDA Class III PMA design and development requirements
• Lead analytical performance strategy for ECD assays and collaborate with RA, biostatistics, and bioinformatics
• Transfer assays to commercial labs and manufacturing
• Partner on statistical analysis plans for approvable device performance claims
• Deliver data-backed updates to FDA and leadership
• Build and mentor a high-performing organization and manage budgets and vendors

Skills

Team leadership

FDA interactions

NGS diagnostics

Regulatory knowledge

Cross-functional collaboration

Education

PhD/MD or MS with experience

Tools

Bioinformatics pipelines

IEC 62304

Job description

Natera, Inc. is seeking a Director of Development to own the end-to-end development and regulatory strategy for our Early Cancer Detection (ECD) IVD products.

You will drive design verification and validation from feasibility through PMA submission, serving as the FDA SME and leading a team of scientists and managers. You will oversee analytical performance strategies, coordinate with Regulatory Affairs, biostatistics, and research, and ensure successful technology transfer to commercial labs