Senior Director, Development - ECD and MCED Products

The role

You will own product development strategy and execution for the Early Cancer Detection and Multi-Cancer Early Detection portfolio. You will guide NGS and cfDNA-based IVD products from feasibility through FDA PMA and post-market support.

What you will do

• Define and own the multi-year assay development strategy and technical lifecycle for the ECD and MCED portfolio.
• Take accountability for the phase-gated execution of all ECD and MCED programs.
• Set team priorities, allocate people, budget, and laboratory resources.
• Establish the analytical verification and validation strategy for the portfolio.
• Partner with clinical, medical, and biostatistics leaders to support study design and performance claims.
• Define regulatory pathways and evidence requirements for PMA submissions.
• Represent the Development approach in senior-level engagement with the FDA.
• Build, retain, and mentor a leadership team of directors, managers, and scientists.
• Partner across research, bioinformatics, biostatistics, software, clinical, regulatory, and commercial functions.
• Communicate portfolio status, risks, and tradeoffs to executive leadership.

Required qualifications

• Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field
• 7+ years of experience in IVD or diagnostic device development under design controls
• 7+ years of experience directing scientific or technical organizations
• 5+ years managing senior managers or directors
• Experience managing multiple concurrent development programs, including budget, resource allocation, and prioritization
• Technical expertise with complex NGS-based diagnostic assays, including assay design, analytical validation, and transfer to a commercial laboratory
• Leadership of the technical and performance evidence for at least one FDA premarket submission (PMA, De Novo, or equivalent high-complexity IVD approval) for an NGS-based device
• Experience in liquid biopsy or molecular diagnostics for clinical oncology, specifically cfDNA-based detection of low-abundance signals at high specificity
• Deep knowledge of FDA regulations (21 CFR Part 820/QMSR, Part 809, and Part 814), ISO 13485:2016, ISO 14971, and IVDR

Nice to have

• Served as the principal technical leader on a PMA submission for an NGS-based oncology device or an equivalent IVD approval outside the US (e.g., IVDR Class C/D, PMDA, NMPA)
• Experience with large prospective or pivotal screening studies in partnership with clinical and biostatistics leaders
• Experience with multi-cancer or cancer screening assays, including multi-cancer classification, cancer signal origin prediction, and operating points requiring very high specificity
• Experience translating Laboratory Developed Tests (LDTs) into FDA-regulated IVD products
• Experience with bioinformatics pipelines and machine-learning-based classifiers as components of a regulated IVD (IEC 62304)

Benefits

• Comprehensive medical, dental, vision, life and disability plans
• Free testing for employees and their 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.