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Director, ECD Development
Natera San Carlos, CA Posted Oct 14
About the role
Join Natera as the Director of Development for our Early Cancer Detection (ECD) In Vitro Diagnostic (IVD) products.
What you'll do
- 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,…
- Contribute to the robust transfer of assays to the commercial laboratory and manufacturing in support of the design transfer and operations teams
- Partner with clinical and biostatistics leaders on statistical analysis plans required for approvable device performance claims in clinical intended-use populations
- Think team by partnering directly across bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial functions to align development efforts with business goals, and drive resourcing and…
What you'll need
Natera lists the full requirements on its posting.