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 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. You will be directly responsible for building high-performing teams, including managers and senior scientists, to drive this development and execution of verification and validation studies. 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 molecular diagnostics for germline-based assays (SNVs, indels, CNVs)
More about this role
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. You will be directly responsible for building high-performing teams, including managers and senior scientists, to drive this development and execution of verification and validation studies. Every test represents a real person, and you will lead a team of scientists and managers to execute performance data packages supporting regulatory submissions. You will serve as the technical subject matter expert in FDA and pharma partner 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 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...
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