Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a Translational IHC Consultant as part of the Early Drug Development team based remotely.
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 requirement 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.
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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
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