Translational IHC (Consultant)
Legend Biotech
9 hours ago
Remote
United States
Clinical Research and Development
Translational IHC Consultant (Early Drug Development) — Remote
Role Overview
- Bridges pathology, biomarker and clinical development to generate high-quality tissue biomarker data to inform baseline, compound MoA, target engagement and safety.
Key Responsibilities
- Collaborate with a CRO to develop, optimize and validate chromogenic IHC, mIF and spatial Omics; define antibody selection/qualification, benchmark and scoring algorithms; support GCP-aligned assay validation as applicable; review study design, validation and analysis reports.
- Partner with TR scientists, clinical development and pathologists to translate biological/clinical questions into quantitative image-based endpoints and computational workflows.
- Interpret data with translational scientists and pathologists; correlate with clinical endpoints and peripheral biomarkers (flow cytometry, cytokines, Omics); provide mechanistic insights into CAR-T infiltration, immune activation/exhaustion and on-/off-target signals.
- Document image processing workflows per internal SOPs; collaborate on training and deliverables.
- Contribute to clinical protocols, regulatory submissions and briefing documents.
Requirements
- Ph.D. in Pathology, Immunology, Oncology or related field.
- 5+ years in translational biomarker development; IHC/mIF assay development in oncology and immunology.
- Deep understanding of TME and immune cell phenotyping.
- Deep understanding of image analysis (segmentation, detection, classification).
- Experience supporting clinical trials.
- Former biopharma TR/pathology lead preferred.
- Proficiency with image analysis platforms such as HALO, VisioPharm, QuPath, etc.
Role Overview
- Bridges pathology, biomarker and clinical development to generate high-quality tissue biomarker data to inform baseline, compound MoA, target engagement and safety.
Key Responsibilities
- Collaborate with a CRO to develop, optimize and validate chromogenic IHC, mIF and spatial Omics; define antibody selection/qualification, benchmark and scoring algorithms; support GCP-aligned assay validation as applicable; review study design, validation and analysis reports.
- Partner with TR scientists, clinical development and pathologists to translate biological/clinical questions into quantitative image-based endpoints and computational workflows.
- Interpret data with translational scientists and pathologists; correlate with clinical endpoints and peripheral biomarkers (flow cytometry, cytokines, Omics); provide mechanistic insights into CAR-T infiltration, immune activation/exhaustion and on-/off-target signals.
- Document image processing workflows per internal SOPs; collaborate on training and deliverables.
- Contribute to clinical protocols, regulatory submissions and briefing documents.
Requirements
- Ph.D. in Pathology, Immunology, Oncology or related field.
- 5+ years in translational biomarker development; IHC/mIF assay development in oncology and immunology.
- Deep understanding of TME and immune cell phenotyping.
- Deep understanding of image analysis (segmentation, detection, classification).
- Experience supporting clinical trials.
- Former biopharma TR/pathology lead preferred.
- Proficiency with image analysis platforms such as HALO, VisioPharm, QuPath, etc.