Senior Principal Scientist, Clinical Biomarkers

Overview

As Clinical Biomarker Lead, you will define and drive biomarker strategies to enable data-driven decisions across Ipsen’s oncology and rare disease programs. You will partner with cross-functional teams to ensure scientifically robust approaches that align with program goals and regulatory expectations. You’ll oversee biomarker development from early clinical stages through registration, shaping patient stratification, pharmacodynamics, and mechanism of action insights. This role offers the chance to advance innovative biomarker platforms and contribute to translational medicine at a global scale.

Responsibilities

• Develop and lead clinical biomarker strategies across oncology and rare disease portfolios to support critical development decisions
• Define biomarker plans for target engagement, pharmacodynamics, patient stratification, and efficacy assessment
• Provide strategic leadership for biomarker data generation from early to late-stage studies
• Select and apply biomarker technologies and analytical approaches across cellular, tissue-based, genomic, transcriptomic, and proteomic platforms
• Drive implementation of biomarker strategies in studies, including protocols, analysis plans, and study documentation
• Oversee biomarker assay development, validation, and data quality assessments
• Collaborate with Clinical Development, Translational Pharmacology, Regulatory Affairs, Biostatistics, and external partners
• Manage external labs and CROs contributing to biomarker data
• Contribute to statistical analysis plans and integrate biomarker findings into development strategy
• Author and review biomarker sections of protocols, reports, and regulatory submissions
• Represent Biomarkers in cross-functional governance and communicate risks, opportunities, and findings
• Manage biomarker budgets, timelines, and outsourcing per Ipsen processes
• Maintain knowledge of emerging biomarker science and regulatory expectations
• Ensure compliance with GCP, GLP, and Ipsen SOPs

Key requirements

• Experience supporting biomarker activities in clinical development with biomarker plan design and implementation
• Strong translational science background and understanding of biomarker roles in target engagement, pharmacodynamics, mechanism of action, and patient stratification
• Experience with diverse biomarker technologies (tissue-based, cellular, genomic, transcriptomic, proteomic)
• Knowledge of biomarker assay development, validation, and data quality for clinical studies
• Excellent communication skills for technical and non-technical audiences
• Oncology and/or rare disease drug development experience is strongly preferred
• Desirable: experience shaping biomarker strategies and integrating data into development decisions
• Desirable: regulatory submission or health authority interaction experience
• Desirable: CRO/vendor management for biomarker data
• Desirable: late-stage or registration-enabling program experience

• Effective communication with diverse audiences
• Influence and align cross-functional teams
• Navigate complexity and prioritize impactful biomarker approaches
• Biomarker strategy development
• Translational science
• Target engagement and pharmacodynamics

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