The opportunity
Join Natera as the Director of Product Development for our Organ Health In Vitro Diagnostic (IVD) products. You will take ownership of the development, verification, and validation of our Organ Health products from feasibility exit through regulatory submission and post-market support.
What you'll do
Own the execution of the technical strategy and phase-gated process of: development, design verification, and validation studies for next-generation sequencing (NGS) based IVD devices to characterize germline mutations (SNV’s, indels, CNV’s etc.) serving as a companion diagnostic (CDx) assay
Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements
Take ownership of the analytical performance strategy (accuracy, precision,: interference, stability, etc) for germline 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 regulatory: submissions, developing a comprehensive approval strategy with RA
- Serve as the technical subject matter expert in correspondence and meetings: with the FDA, and pharma partners 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
