Senior Director, Research Strategy and Operations (Core Team Leader)
Core
Lead the end-to-end development lifecycle of complex regulated diagnostic products (LDT, 510(k), PMA) from concept to commercial launch, acting as the strategic glue for cross-functional teams.
Role type
Senior Director, Research Strategy and Operations (Core Team Leader)
Builds
Regulated diagnostic products (Oncology Diagnostics, NGS, Liquid Biopsy) for clinical care
Domain
Life Sciences / Diagnostics / Oncology
Deliverable
production ML models
Required skills
Matrix leadership without direct authority, Stage-Gate governance, Design Control (21 CFR 820, ISO 13485), FDA regulatory pathways (PMA/510k), cross-functional negotiation, strategic trade-off decision making, operational scalability planning
Preferred skills
MBA, experience in Oncology Diagnostics, NGS, or Liquid Biopsy, FDA Class II/III medical device development
Technologies
NGS, Liquid Biopsy, LDT
Responsibilities
Serve as single point of accountability for development lifecycle and Target Product Profile; Lead cross-functional Core Team (R&D, Clinical, Regulatory, Quality, Software, Operations) without direct line authority; Lead formal Stage-Gate Reviews and synthesize complex data for executive leadership; Champion Design Control compliance and guide regulatory pathways; Oversee transition from R&D to Clinical Lab Operations; Mediate friction between functional groups to ensure alignment
Seniority
Senior Director, strategic leadership & matrix management