Senior Director, Development - ECD and MCED Products

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.

• 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 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

• 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

• 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