The opportunity
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…
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, bioinformatics and research teams
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 go/no-go recommendations at phase gates
What they're looking for
- Deliver the analytical performance data package supporting Class III PMA: submissions, developing a comprehensive approval strategy with RA
- Serve as the technical subject matter expert in correspondence and meetings: with the FDA, defending performance evidence using data
- Treat Quality Management System (QMS) requirements (ISO 13485:2016, FDA QMSR: 21 CFR Part 820, ISO 14971, IEC 62304) and regulatory guidance as the foundation of product development rather than a final check
- Build, develop, and retain a high-performing organization of scientists and: managers, optimizing program budgets and external vendor partnerships
