Director, Organ Health IVD Product Development

Natera; Austin (TX); On-site; USD 185,000 - 231,000; Full time

Job summary

Natera in Austin, TX is seeking a Director of Product Development for Organ Health IVD products. You will lead development, verification, and validation, and drive regulatory submissions.

You will build and manage scientists and managers to deliver robust performance data packages for FDA submissions. You will partner with bioinformatics, biostatistics, software, regulatory, and clinical teams to align strategy with business goals, manage budgets, and ensure smooth design transfer to

Qualifications

• Deep expertise in NGS-based diagnostic assays and validation.
• Experience interacting with FDA for regulatory submissions.
• Background in molecular diagnostic development and germline assays.

Responsibilities

• Oversee technical strategy and phase-gated development for NGS IVDs.
• Ensure compliance with FDA Class III design requirements.
• Lead analytical performance strategy for germline assays with cross-functional teams.
• Transfer assays to commercial lab and manufacturing with design transfer.
• Collaborate with clinical and biostatistics for analysis plans supporting claims.

Skills

NGS diagnostics

FDA interactions

Molecular diagnostics

Regulatory knowledge

Cross-functional leadership

Education

PhD/MD or equivalent in Life Sciences

MS with relevant industry experience

Job description

Austin, TX

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

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Austin, TX

$185,000 - $231,200 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits 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!

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.

Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Natera’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.