Director, ECD Development

POSITION SUMMARY:

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.

PRIMARY RESPONSIBILITIES:

• 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), biostatistics, bioinformatics and research teams