Director, Organ Health IVD Product Development

The role

You will lead the development, verification, and validation of Organ Health IVD products from feasibility through regulatory submission. You will build and manage teams of scientists and managers to execute performance data packages for regulatory submissions.

What you will do

• Own technical strategy and phase-gated process for NGS-based IVD devices.
• Ensure compliance with FDA Class III (PMA) design and development requirements.
• Take ownership of analytical performance strategy for germline assays.
• Contribute to the transfer of assays to commercial laboratory and manufacturing.
• Partner with clinical and biostatistics leaders on statistical analysis plans.
• Align development efforts with business goals through cross-functional partnership.
• Deliver analytical performance data packages supporting regulatory submissions.
• Serve as technical subject matter expert in FDA and pharma partner interactions.
• Build, develop, and retain a high-performing organization of scientists and managers.
• Use data to identify technical and timeline risks.

Required qualifications

• Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field; an MS with additional relevant industry experience will be considered
• 6+ years of experience in IVD or diagnostic device development under design controls
• 5+ years of experience directing scientific or technical teams
• Deep technical expertise with complex NGS-based diagnostic assays
• Demonstrated direct experience in FDA interactions (e.g., Pre-Submission meetings) for a molecular diagnostic or NGS-based device
• Experience in molecular diagnostics for germline-based assays (SNVs, indels, CNVs)
• Working knowledge of FDA premarket pathways for high-complexity IVD approvals
• Deep knowledge of FDA regulations (21 CFR Part 820/QMSR, Part 809, and Part 814), ISO 13485:2016, ISO 14971, and IVDR
• Ability to translate device development requirements to technical and non-technical teams
• Demonstrated experience in building and developing high-performing teams, including managers and senior scientists
• Strong understanding of germline-based assay diagnostics, design-controlled product development, and clinical validation

Nice to have

• Served as a principal technical contributor on a PMA, De Novo, or Breakthrough Device submission for an NGS-based germline assay
• Experience with use of multiple clinical trial assays (CTAs) being used for patient enrollment and later bridging to the final IVD candidate using clinical bridging studies
• Experience translating Laboratory Developed Tests (LDTs) into FDA-regulated IVD products
• Experience with bioinformatics pipelines and companion software as components of a regulated IVD (IEC 62304)
• Experience developing and validating orthogonal tests (such as Sanger sequencing, qPCR, ddPCR, MLPA, etc.)

Benefits

• Comprehensive medical, dental, vision, life and disability plans
• Free testing for employees and immediate families
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Employee referral program

About the company

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The team consists of statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals.