Director – Organ Health IVD Product Development

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 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

KNOWLEDGE, SKILLS, AND ABILITIES: 

• 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)
• Push for clarity and outcome-driven action across the organization, with a solutions-oriented approach to both technical challenges and cross-functional team dynamics
• Working knowledge of FDA premarket pathways for high-complexity IVD approvals
• Deep knowledge of FDA regulations (21 CFR Part 820/QMSR, Part 809, and Part 814), ISO 13485:2016, ISO 14971, and IVDR
• Deliver unvarnished, data-backed updates to internal and external stakeholders (including the FDA and executive leadership), pushing for decisions grounded in analytical evidence
• Ability to translate the requirements of device development to technical and non-technical teams, enabling robust development processes and performance study designs
• Demonstrated experience in building and developing high-performing teams, including managers and senior scientists; and driving execution across functions in a matrixed organization
• Strong understanding of germline-based assay diagnostics, design-controlled product development, and clinical validation, including analytical performance characterization of NGS assays

PREFERRED QUALIFICATIONS: 

• Served as a principal technical contributor on a PMA, De Novo, or Breakthrough Device submission for an NGS-based germline assay
• Experience with use of multiple clinical trial assays (CTAs) being used for patient enrollment and later bridging to the final IVD candidate using clinical bridging studies
• Experience translating Laboratory Developed Tests (LDTs) into FDA-regulated IVD products
• Experience with bioinformatics pipelines and companion software as components of a regulated IVD (IEC 62304)
• Experience developing and validating orthogonal tests (such as Sanger sequencing, qPCR, ddPCR, MLPA, etc.) for validating accuracy of NGS in challenging regions of the genome

Austin, TX 185000 - 231200 USD