Principal Scientist, GI/Liver Biomarkers & Translational Research
Core
Lead biomarker and translational strategy for clinical-stage GI/IBD and liver disease programs, translating mechanism into fit-for-purpose biomarker plans from early development through Phase II/III.
Role type
Principal Scientist (hands-on scientific leadership)
Builds
Clinical-stage drug development programs for inflammatory bowel disease and liver disease
Domain
Biopharmaceuticals, Gastroenterology, Hepatology, Translational Medicine
Required skills
Human immunology, GI/IBD and liver disease biology, clinical biomarker strategy, assay development and validation, cross-functional leadership, regulatory document authoring, multi-omic data integration, mentorship
Preferred skills
Crohn's disease and ulcerative colitis experience, liver inflammation and fibrosis expertise, Phase I-III study support, single-cell or spatial profiling, transcriptomics, proteomics, digital pathology, microbiome analysis
Technologies
Single-cell profiling, spatial profiling, transcriptomics, proteomics, cytometry, digital pathology, genetics, microbiome analysis
Responsibilities
Lead end-to-end biomarker strategy including target engagement, pharmacodynamic, and safety biomarkers; Translate program hypotheses into decision-focused clinical biomarker plans and sampling strategies; Provide hands-on scientific leadership for blood, stool, tissue, endoscopic, histologic, imaging, and multi-omic approaches; Lead assay selection, characterization, qualification, and vendor oversight; Partner with Clinical Development, Biostatistics, and Regulatory to embed biomarker objectives into protocols; Lead integrated interpretation of high-dimensional datasets to generate actionable development recommendations; Author biomarker content for protocols, regulatory submissions, and publications; Mentor colleagues and establish scientific standards across the portfolio
Seniority
Principal, hands-on scientific leadership