Senior Director, Development ECD and MCED Products

POSITION SUMMARY:

Join Natera as the Senior Director of Development for our Early Cancer Detection (ECD) and Multi-Cancer Early Detection (MCED) portfolio. You will take ownership of product development strategy and execution guiding Next-Generation Sequencing (NGS) and cell-free DNA-based (cfDNA) In Vitro Diagnostic (IVD) products from feasibility through FDA Premarket Approval (PMA) and post-market support. Every test represents a real person and you will build an organization of scientific contributors and managers to deliver robust clinical tools. You will establish priorities allocate resources and represent development with the FDA and executive leadership ensuring that scientific rigor and data drive all regulatory and portfolio decisions.

PRIMARY RESPONSIBILITIES:

• Define and own the multi-year assay development strategy and technical lifecycle for the ECD and MCED portfolio in alignment with corporate and R&D strategy
• Take accountability for the phase-gated execution of all ECD and MCED programs overseeing the development design verification and validation of NGS-based cancer detection IVD devices using cfDNA methylation and other analyte classes.
• Set team priorities allocate people budget and laboratory resources and make or recommend go/no-go decisions to executive leadership
• Establish the analytical verification and validation strategy for the portfolio to ensure robust assays transfer seamlessly to commercial manufacturing
• Partner with clinical medical and biostatistics leaders to support approvable pivotal and prospective study design statistical analysis plans and performance claims for screening-population use in both the ECD and MCED intended-use claims
• Define regulatory pathways and evidence requirements for PMA submissions for ECD and MCED in an evolving regulatory landscape. Be facile in representing the Development approach and activities in senior-level engagement with the FDA (e.g. pre-submission meetings and advisory panels as applicable) and accountable for the analytical performance data packages supporting each submission
• Build retain and mentor a leadership team of directors managers and scientists optimizing the organizations budget and external vendor partnerships
• Think team by partnering directly across research bioinformatics biostatistics software clinical regulatory and commercial functions to deliver design-controlled IVD products in a highly cross-functional environment
• Communicate portfolio status risks and tradeoffs to executive leadership and drive alignment on enterprise priorities
• Ensure the organization operates within Nateras QMS and all applicable guidance (ISO 13485:2016 FDA QMSR (21 CFR Part 820) ISO 14971 IEC 62304 etc) and partner with Quality to maintain audit readiness and strengthen design control practices

REQUIRED QUALIFICATIONS:

• Advanced degree (PhD MD or equivalent) in Molecular Biology Biomedical Engineering Life Sciences or a related field
• 7 years of experience in IVD or diagnostic device development under design controls
• 7 years of experience directing scientific or technical organizations with 5 years managing senior managers or directors

KNOWLEDGE SKILLS AND ABILITIES:

• Demonstrated experience managing multiple concurrent development programs with full accountability for budget resource allocation and prioritization
• Deep technical expertise with complex NGS-based diagnostic assays including assay design analytical validation and transfer to a commercial laboratory
• Demonstrated leadership of the technical and performance evidence for at least one FDA premarket submission (PMA De Novo or equivalent high-complexity IVD approval) for an NGS-based device including senior-level FDA interactions
• Experience in liquid biopsy or molecular diagnostics for clinical oncology specifically cfDNA-based detection of low-abundance signals at high specificity
• Push for clarity and outcome-driven action at the executive level taking ownership of technical and programmatic challenges without relying on a finished playbook
• Clear direct communication to articulate complex regulatory and technical strategies to internal and external stakeholders driving decisions based on data
• Deep knowledge of FDA regulations (21 CFR Part 820/QMSR Part 809 and Part 814) ISO 13485:2016 ISO 14971 and IVDR
• Ability to translate scientific strategy into rigorous business cases and resourcing plans exercising judgment under uncertainty

PREFERRED QUALIFICATIONS:

• Served as the principal technical leader on a PMA submission for an NGS-based oncology device or an equivalent IVD approval outside the US (e.g. IVDR Class C/D PMDA NMPA)
• Experience with large prospective or pivotal screening studies in partnership with clinical and biostatistics leaders
• Experience with multi-cancer or cancer screening assays including multi-cancer classification cancer signal origin prediction and operating points requiring very high specificity
• Experience translating Laboratory Developed Tests (LDTs) into FDA-regulated IVD products
• Experience with bioinformatics pipelines and machine-learning-based classifiers as components of a regulated IVD (IEC 62304)

OUR OPPORTUNITY

Natera is a global leader in cell-free DNA (cfDNA) testing dedicated to oncology womens 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 youll work hard and grow quickly. Working alongside the elite of the industry youll 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!

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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.

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