Director, Organ Health IVD Product Development

The posting, as Natera wrote it

POSITION SUMMARY

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.

PRIMARY RESPONSIBILITIES

• 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
• 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
• Use data to identify technical and timeline risks, including ISO 14971 risk management deliverables, making risk-based decisions on mitigation and escalation

REQUIRED QUALIFICATIONS

• Advanced degree (PhD, MD, or equivalent) in Molecular Biolo

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s include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com .

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

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For more information

• BBB announcement on job scams
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