Director, ECD Development
Core
Lead the end-to-end development, verification, and validation of Early Cancer Detection (ECD) Next Generation Sequencing (NGS) in vitro diagnostic (IVD) products for FDA Class III PMA submission.
Role type
Director of Development (Senior IC with team leadership)
Builds
FDA-approved NGS-based liquid biopsy assays for early cancer detection
Domain
Molecular diagnostics / Oncology / In Vitro Diagnostics (IVD)
Deliverable
production ML models
Required skills
NGS assay design and validation, FDA PMA regulatory strategy, analytical performance strategy (LOD/LOQ, precision, linearity), risk management (ISO 14971), team leadership, cross-functional partnership
Preferred skills
PMA/De Novo submission experience, pivotal clinical validation studies, LDT to IVD translation, bioinformatics pipeline integration
Technologies
Next Generation Sequencing (NGS), cfDNA, methylation analysis, IEC 62304
Responsibilities
Own technical strategy and phase-gated development process; ensure compliance with FDA Class III design controls; lead analytical performance data packages; serve as technical SME for FDA interactions; build and retain high-performing teams; manage program budgets and vendor partnerships; identify technical and timeline risks.
Seniority
Director, hands-on technical leadership
