Head of Organ Health NGS IVD Development

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

Descrizione del lavoro

Natera, Inc. in Austin, TX is seeking a Director of Product Development to own the development, verification, and validation of Organ Health IVD products from feasibility to regulatory submission and post-market support.

You will build and lead a high-performing team of scientists and managers, partner with Regulatory Affairs, biostatistics, and clinical teams, and serve as the technical expert in FDA interactions to defend performance data.

Competenze

• PhD/MD or equivalent in Molecular Biology, Biomedical Engineering, Life Sciences, or related field.
• 6+ years in IVD or diagnostic device development under design controls.
• 5+ years directing scientific or technical teams.

Mansioni

• Own the technical strategy and phase-gated development for NGS-based IVD devices.
• Ensure rigorous FDA Class III (PMA) design and development compliance.
• Own analytical performance strategy for germline assays with cross-functional teams.
• Transfer assays to a commercial laboratory and manufacturing.
• Partner with clinical and biostatistics on analysis plans for approvable device claims.
• Collaborate across bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial functions.
• Deliver analytical performance data package supporting regulatory submissions.
• Serve as SME in FDA and pharma partner meetings.
• Treat QMS/regulatory guidance as the foundation of development.
• Build and retain high-performing teams and manage budgets.
• Use data to identify risks and drive mitigation.

Conoscenze

NGS design

FDA interactions

Team leadership

Regulatory strategy

Clinical validation

Formazione

PhD/MD or equivalent

MS with industry experience

Descrizione del lavoro

Natera, Inc. in Austin, TX is seeking a Director of Product Development to own the development, verification, and validation of Organ Health IVD products from feasibility to regulatory submission and post-market support.

You will build and lead a high-performing team of scientists and managers, partner with Regulatory Affairs, biostatistics, and clinical teams, and serve as the technical expert in FDA interactions to defend performance data.