Senior Director, Product Development

Summary

Join Natera as a Senior Director of Product Development to spearhead the development and regulatory submission of innovative early cancer detection products. Oversee all aspects of product development, from research to post-market support. Lead a team in creating the performance data package for a Class III PMA application, collaborating with regulatory affairs. Design and execute clinical validation studies meeting FDA requirements. Work cross-functionally with research, bioinformatics, biostatistics, software engineering, clinical, regulatory quality, and commercial teams. Ensure compliance with Natera’s QMS and applicable standards (ISO 13485, FDA QSR, etc.). Identify and mitigate potential risks in development and regulatory processes.

Requirements

• Advanced degree (PhD, MD, or equivalent) in Molecular Biology, Biomedical Engineering, Life Sciences, or a related field
• Minimum 10+ years of experience in diagnostic device development, with a strong focus on Class III PMA-level submissions
• Required prior experience with complex NGS-based diagnostic devices, with proven ability to understand and then translate the requirements of device development to other technical and non-technical teams to enable outstanding development processes and performance study designs
• Proven track record of leading FDA Class III PMA or ex-US PMA submissions for novel diagnostic technologies and leading roll in interactions with regulatory agencies
• Experience in liquid biopsy, molecular diagnostics in oncology applications
• Deep knowledge of FDA regulations, ISO 13485, QSR, IVDR, and other applicable standards
• Strong understanding of oncology diagnostics, design-controlled product development, and clinical validation
• Demonstrated experience in leading cross-functional teams, managing complex projects, and driving regulatory strategies
• Ability to articulate complex regulatory and technical strategies to internal and external stakeholders to surface and drive decisions based on business and product requirements

Responsibilities

• Drive development, design verification and validation of an innovative early cancer detection device using NGS and alternative analytes, ensuring compliance with FDA Class III NGS diagnostic device regulations
• Lead a team to create the performance data package needed for the preparation and submission of a Class III PMA application, working closely with regulatory affairs to develop a comprehensive approval strategy and interacting as a subject matter expert in correspondence and meetings with the FDA
• Collaborate with clinical and regulatory teams to design and execute clinical validation studies that meet FDA and global regulatory requirements for submissions
• Work collaboratively with research, bioinformatics, biostatistics, software engineering, clinical, regulatory quality, and commercial teams to align development efforts with business goals
• Ensure product development follows Natera’s QMS and all applicable guidance (ISO 13485, FDA QSR, etc), to meet regulatory and safety standards
• Identify potential risks in the development and regulatory process and implement strategies to mitigate them

Benefits

• Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• 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!