Director of Early Cancer Detection NGS Programs

Natera; San Carlos (CA); À distance; USD 229 000 - 286 000; Plein temps

Résumé du poste

Natera is seeking a Director of Development to own the regulatory-driven development of ECD IVD products. You will lead a team of scientists to generate performance data for PMA submissions and serve as a technical expert in FDA communications.

You will drive cross-functional collaboration across bioinformatics, biostatistics, software, clinical, regulatory, and commercial teams to align development with business goals and ensure timely phase-gate decisions and risk management.

Qualifications

• Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or related field; MS with relevant experience considered.
• 6+ years in IVD or diagnostic device development under design controls.
• 5+ years directing scientific or technical teams.

Responsabilités

• Own the execution of the technical strategy and development for ECD IVD devices.
• Ensure compliance with FDA Class III design and development requirements.
• Lead analytical performance strategy for ECD assays.
• Transfer assays to commercial lab and manufacturing.
• Collaborate with RA, biostatistics, bioinformatics and research teams.

Connaissances

NGS diagnostics

FDA interactions

Team leadership

Cross-functional

Design controls

Molecular biology

cfDNA assays

Regulatory knowledge

Analytical validation

Formation

PhD in Molecular Biology

MD (optional)

Outils

Bioinformatics pipelines

Regulatory submission tools

ISO 14971

Description du poste

Natera is seeking a Director of Development to own the regulatory-driven development of ECD IVD products. You will lead a team of scientists to generate performance data for PMA submissions and serve as a technical expert in FDA communications.

You will drive cross-functional collaboration across bioinformatics, biostatistics, software, clinical, regulatory, and commercial teams to align development with business goals and ensure timely phase-gate decisions and risk management.