Senior Director, Development - ECD and MCED Products
Core
Own the multi-year product development strategy and execution for Early Cancer Detection (ECD) and Multi-Cancer Early Detection (MCED) NGS-based IVD products, guiding them from feasibility through FDA Premarket Approval (PMA) and post-market support.
Role type
Senior Director, Product Development (IVD)
Builds
FDA-approved NGS-based cell-free DNA (cfDNA) diagnostic devices for oncology screening
Domain
Molecular diagnostics / Oncology / In Vitro Diagnostics (IVD)
Deliverable
production ML models
Required skills
NGS assay design and validation, cfDNA analysis, FDA PMA submission leadership, liquid biopsy expertise, regulatory strategy (FDA/ISO), team leadership, budget allocation, cross-functional partnership
Preferred skills
PMA principal technical leader experience, large prospective screening study design, multi-cancer classification algorithms, LDT-to-IVD transition, bioinformatics pipeline integration
Technologies
Next-Generation Sequencing (NGS), cell-free DNA (cfDNA), methylation analysis, bioinformatics pipelines, machine learning classifiers
Responsibilities
Define multi-year assay development strategy, oversee phase-gated execution of ECD/MCED programs, allocate resources and make go/no-go decisions, establish analytical validation strategies, partner on pivotal study design, represent development with FDA, build and mentor leadership teams, ensure QMS compliance
Seniority
Senior Director, hands-on IC with management of senior managers
