Organ Health IVD Product Development Director

Natera; Austin (TX); In loco; USD 185.000 - 231.000; Tempo pieno

Descrizione del lavoro

Natera in Austin, TX is seeking a Director of Product Development for Organ Health IVD products. You will lead development, verification, and validation, and drive regulatory submissions.

You will build and manage scientists and managers to deliver robust performance data packages for FDA submissions. You will partner with bioinformatics, biostatistics, software, regulatory, and clinical teams to align strategy with business goals, manage budgets, and ensure smooth design transfer to

Competenze

• Deep expertise in NGS-based diagnostic assays and validation.
• Experience interacting with FDA for regulatory submissions.
• Background in molecular diagnostic development and germline assays.

Mansioni

• Oversee technical strategy and phase-gated development for NGS IVDs.
• Ensure compliance with FDA Class III design requirements.
• Lead analytical performance strategy for germline assays with cross-functional teams.
• Transfer assays to commercial lab and manufacturing with design transfer.
• Collaborate with clinical and biostatistics for analysis plans supporting claims.

Conoscenze

NGS diagnostics

FDA interactions

Molecular diagnostics

Regulatory knowledge

Cross-functional leadership

Formazione

PhD/MD or equivalent in Life Sciences

MS with relevant industry experience

Descrizione del lavoro

Natera in Austin, TX is seeking a Director of Product Development for Organ Health IVD products. You will lead development, verification, and validation, and drive regulatory submissions.

You will build and manage scientists and managers to deliver robust performance data packages for FDA submissions. You will partner with bioinformatics, biostatistics, software, regulatory, and clinical teams to align strategy with business goals, manage budgets, and ensure smooth design transfer to