The opportunity
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…
What you'll do
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
What they're looking for
- 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
