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Senior Director, Development - ECD and MCED Products
Natera San Carlos, CA Posted Oct 14
About the role
Join Natera as the Senior Director of Development for our Early Cancer Detection (ECD) and Multi-Cancer Early Detection (MCED) portfolio.
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…
- 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…
- Define regulatory pathways and evidence requirements for PMA submissions for ECD and MCED in an evolving regulatory landscape.
What you'll need
Natera lists the full requirements on its posting.