Senior Director, Research & Development
Core
Leading late-stage assay and product development for molecular diagnostics, focusing on design-controlled IVDs, CDx, IUOs, and LDTs to deliver precision diagnostics.
Role type
Senior Director, Regulated Assay Development
Builds
Molecular diagnostic products (IVD, CDx, IUO, LDT) and scalable development systems
Domain
Life Sciences / Molecular Diagnostics / Regulated Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design-controlled product development, IVD/CDx validation, regulatory submissions (FDA/IVDR), cross-functional leadership, process standardization, team mentorship, resource planning
Preferred skills
Audit/inspection support, companion diagnostic development, pharma partnerships, automation/LIMS experience, 21 CFR Part 11 software tools
Technologies
LIMS, ELNs, 21 CFR Part 11 compliant software
Responsibilities
Lead late-stage development and launch readiness for molecular diagnostic programs; Provide strategic leadership for design controls and validation; Drive regulatory submission support; Oversee documentation strategy for inspection readiness; Lead complex issue resolution and root cause investigations; Mentor high-performing teams of scientists and specialists
Seniority
Senior Director, hands-on IC with people management
