Translational IHC (Consultant)

Role Overview

This role bridges pathology, biomarker and clinical development, ensuring high-quality tissue biomarker data generation to inform baseline, compound MoA, target engagement and safety.

Key Responsibilities

• Collaborate with selected CRO to develop, optimize and validate chromogenic IHC, mIF and spatial Omics as well as ensure assays are phase-appropriate and fit-for-purpose (exploratory to clinical and potential CDx pathway).
• Define technical requirements and quality criteria such as antibody selection and qualification, benchmark and scoring algorithms and support GCP-aligned assay validation whenever applicable.
• Review study design, validation and analysis reports.
• Partner with TR scientists, clinical development and pathologists to translate biological questions and clinical challenges into quantitative image-based endpoints and computational workflows.
• Interpret data in collaboration with Translational scientists and pathologists. Correlate findings with clinical endpoints and peripheral biomarkers from Flow cytometry, cytokine and Omics data. Provide mechanistic insights in CAR-T infiltration, immune activation and exhaustion and on- and off-target signals.
• Documents image processing workflows in compliance with internal SOPs and collaborate with global teams for training and deliverables.
• Contribute clinical protocols and regulatory submissions and briefing documents.
• Candidate has the authority to make decisions related to methodologies and approaches development processes. He/she can make decisions related to project execution, including timelines and milestones. Higher-level approvals are required for those related to significant technical selection, strategic shifts, or major collaborations that have substantial scientific and long-term implications.

Requirements

• Ph.D in Pathology, Immunology, Oncology or related field.
• 5+ years of experience in Translational biomarker development; IHC/mIF assay development in oncology and immunology.
• Deep understanding of TME, Immune cell phenotyping.
• Deep understanding of image analysis method such as segmentation, detection and classification, etc.
• Experience supporting clinical trials.
• Former biopharma TR/pathology lead preferred
• Proficiency in image analysis platforms such as HALO, VisioPharm, QuPath, etc.

Pay

Commensurate with experience.

Schedule

Remote