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Senior Director, Assay Development
DELFI Diagnostics, Inc.Liquid Biopsy company
Palo Alto, United StatesDirector
DFJ Growth
Menlo Ventures
OrbiMed
Eli Lilly and Company
Point72
Foresite Capital
About the role
TL;DR
Lead assay development for cancer screening tests.
- •As Senior Director of Assay Development, you will own all development activities across DELFI’s NGS-based cancer screening portfolio
- •driving the transition of innovative assays into verified, validated, and manufacturable IVD products.
- •Key Responsibilities Own end-to-end assay development strategy across all LDT and IVD programs
- •from study design and execution through protocol approval, analytical validation, regulatory documentation, and FDA PMA submissions Establish and enforce compliant analytical performance claims aligned to CLIA, FDA, and international IVD standards (21 CFR Part 820, ISO 13485, ISO 14971, IVDR) Contribute to and/or lead Formal Design Reviews at key milestones; partner with Systems Engineering to ensure product requirements are fully addressed through design verification Oversee reagent development and qualification, automated process scale-up, and statistical process control (SPC) for lab production environments Lead design transfer activities across programs, ensuring robust handoffs to manufacturing and sustained assay performance at commercial scale Requirements PhD or MS in Molecular Biology, Biochemistry, Biomedical Engineering, Genomics, or a related discipline 12+ years in IVD and/or LDT assay development in regulated environments Hands-on expertise in AV and design verification of multi-marker genomic or ‘omic-based assays, with direct experience contributing to FDA regulatory submissions Deep knowledge of IVD regulatory frameworks: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR Proven track record designing scalable processes, SOPs, quality systems, and operational infrastructure in regulated IVD environments
Required skills
Project ManagementCompliance Management
Domain expertise
biotech