Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care. Backed by Lightspeed and Sequoia.
About the role
Join Natera as the Director of Development for our Early Cancer Detection (ECD) In Vitro Diagnostic (IVD) products. You will take ownership of the development, verification, and validation of our early cancer detection (ECD) Next Generation Sequencing products from feasibility exit through regulatory submission and post-market support. Every test represents a real person, and you will lead a team of scientists and managers to execute the performance data packages supporting PMA submissions. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field, an MS with additional relevant industry experience will be considered
- 6+ years of experience in IVD or diagnostic device development under design controls
- 5+ years of experience directing scientific or technical teams
- Deep technical expertise with complex NGS-based diagnostic assays, including assay design, analytical validation, and transfer to a commercial laboratory or manufacturing
- Demonstrated direct experience in FDA interactions (e.g., Pre-Submission meetings) for a molecular diagnostic or NGS-based device
- Experience in liquid biopsy or molecular diagnostics for clinical oncology, specifically cfDNA-based detection of low-abundance signals at high specificity
More about this role
Join Natera as the Director of Development for our Early Cancer Detection (ECD) In Vitro Diagnostic (IVD) products. You will take ownership of the development, verification, and validation of our early cancer detection (ECD) Next Generation Sequencing products from feasibility exit through regulatory submission and post-market support. Every test represents a real person, and you will lead a team of scientists and managers to execute the performance data packages supporting PMA submissions. You will serve as the technical subject matter expert in FDA interactions, partnering across functions to deliver design-controlled diagnostic products that directly impact patient care.
- Own the execution of the technical strategy and phase-gated process of of development, design verification, and validation studies for ECD IVD devices utilizing cfDNA, methylation and other potential analytes
- Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements
- Take ownership of the analytical performance strategy (limit of blank/detection, precision, linearity, interference, stability) for ECD assays, partnering directly with Regulatory Affairs (RA),...
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