[Hiring] Senior Director, Development @Natera

Role Description

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.

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

Requirements

• 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
• Build, retain, and mentor a leadership team of directors, managers, and scientists, optimizing the organization’s 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 Natera’s 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

Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Free testing for Natera employees and their immediate families in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• A generous employee referral program

Company Description

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.