Director of ECD NGS Development

Natera; United States; Teletrabalho; USD 229 000 - 286 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive Benefits

Fertility care benefits

401k benefits

Commuter benefits

Resumo da oferta

Natera is seeking a Director of Development for its ECD IVD products. You will own the development, verification, and validation of Next Gen Sequencing assays from feasibility to regulatory submission and post-market support, leading scientists and managers and partnering across functions for PMA submissions.

You will serve as the technical expert in FDA interactions, drive design control compliance, and build a high-performing organization while optimizing program budgets and external

Qualificações

• Deep expertise with NGS-based diagnostic assays and analytical validation.
• Direct experience interacting with FDA for molecular diagnostics.
• Experience leading scientific or technical teams.
• Knowledge of liquid biopsy or cfDNA assays is a plus.
• Understanding of FDA design controls and QMS for IVD devices.
• Ability to translate device development to cross-functional teams.

Responsabilidades

• Own development strategy and phase-gated processes for ECD IVD programs.
• Lead verification and validation studies for cfDNA-based tests.
• Define analytical performance strategy and liaise with RA and biostatistics.
• Transfer assays to commercial labs and support design transfer.
• Collaborate with clinical and biostatistics for validation plans.
• Provide data-driven updates to FDA and leadership.

Conhecimentos

NGS-based diagnostics

FDA interactions

Team leadership

Cross-functional collaboration

Formação académica

PhD/MD or equivalent in Life Sciences

MS with relevant industry experience

Descrição da oferta de emprego

Natera is seeking a Director of Development for its ECD IVD products. You will own the development, verification, and validation of Next Gen Sequencing assays from feasibility to regulatory submission and post-market support, leading scientists and managers and partnering across functions for PMA submissions.

You will serve as the technical expert in FDA interactions, drive design control compliance, and build a high-performing organization while optimizing program budgets and external