Director, Pathology Services
Core
Lead the Pathology Services team to develop, manufacture, and commercialize highly regulated companion diagnostic medical devices for biopharma partners, focusing on tissue sample review, scoring algorithm development, and digital pathology strategy.
Role type
Director, Pathology Services (Companion Diagnostics)
Builds
Companion diagnostic assays and medical devices for biopharma clinical trials
Domain
Biotechnology / Precision Medicine / Companion Diagnostics
Deliverable
production ML models | product features
Required skills
Pathology workflow management, Companion diagnostic development, Cancer diagnostic assay expertise (IHC), Cross-functional collaboration, Digital pathology strategy, Regulatory study oversight (IRB/IEC)
Preferred skills
Management of pathologists and consultants, Protocol development for reagent optimization, Commercial product launch support
Technologies
Digital image analysis tools, IHC assays, Digital pathology platforms
Responsibilities
Manage project assignments and workload for pathologists, Develop workflow processes for pathology and clinical trials, Oversee pathologist ICQ tissue sample review and scoring algorithm development, Collaborate with Clinical, R&D, Regulatory, and QA teams, Prepare digital pathology strategy for assay scoring training, Oversee IQC evaluation of tissue samples for CDx assays, Present growth opportunities to biopharma partners
Seniority
Director, strategic leadership & hands-on management