Senior Principal Scientist

Clinical Biomarker Lead, Senior Scientist

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Division / Function: Early Development, Translational Sciences
Location: London or Paris
Summary & Purpose Of The Position

To develop and lead clinical biomarker strategies that enable data-driven decision-making across clinical development and maximize the value of Ipsen's oncology and rare disease portfolio. The Biomarker Lead serves as a strategic partner to cross‑functional development teams, ensuring biomarker approaches are scientifically robust, aligned with program objectives, and support critical development milestones. The position provides biomarker leadership from early clinical development through registration, defining data‑generation strategies that inform patient selection, mechanism of action, clinical benefit, and regulatory decision‑making. The role contributes expertise in biomarker development, validation and implementation while fostering innovative approaches that strengthen Ipsen's biomarker capabilities across therapeutic areas.

Main Responsibilities & Technical Competencies

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• Develop and lead clinical biomarker strategies across Ipsen's oncology and rare disease portfolio to support critical development and portfolio decisions.
  
• Define biomarker plans to support target engagement, pharmacodynamic and mechanistic understanding, patient stratification, and support efficacy assessment across clinical development.
  
• Provide strategic leadership for biomarker data generation from early clinical development through late‑stage and registration‑enabling studies, as appropriate.
  
• Select and apply the most appropriate biomarker technologies and analytical approaches to address program objectives, including cellular, tissue‑based, genomic, transcriptomic, proteomic, and emerging platform technologies.
  
• Drive implementation of biomarker strategies within clinical studies, including development of protocols, schedules of activities, laboratory manuals, biomarker analysis plans, and study‑related documentation.
  
• Provide scientific oversight of biomarker assay development, fit‑for‑purpose validation, and analytical performance assessments to ensure data quality and fitness for intended use.
  
• Collaborate with Clinical Development, Translational Pharmacology, Companion Diagnostics, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, and external partners to ensure successful execution and interpretation of biomarker activities.
  
• Lead the selection, oversight, and performance management of external laboratories, CROs, and other vendors supporting biomarker development and analysis.
  
• Contribute to biomarker components of statistical analysis plans and integrate biomarker findings into study interpretation and development strategy.
  
• Author, review, and contribute to biomarker sections of protocols, study reports, regulatory submissions, briefing documents, and health authority responses.
  
• Represent Biomarkers on cross‑functional project teams and governance forums, effectively communicating biomarker strategies, risks, opportunities, and key findings.
  
• Manage biomarker budgets, contracts, timelines, and outsourcing activities in accordance with Ipsen processes and standards.
  
• Maintain current knowledge of emerging biomarker science, diagnostic technologies, and global regulatory expectations relevant to biomarker and precision medicine development.
  
• Ensure compliance with applicable regulations, industry standards, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Ipsen SOPs.
  

Behavioural Competencies Required

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• Communicates Effectively – Translates complex scientific concepts into clear, impactful messages tailored to diverse audiences, from technical experts to senior leaders and non‑scientific stakeholders.
  
• Influences – Builds alignment and gains commitment across cross‑functional teams and external partners to advance biomarker strategies and achieve program objectives.
  
• Manage Complexity – Evaluates scientific opportunities and competing priorities critically, focusing efforts on biomarker approaches that generate meaningful evidence and support decision‑making.
  
• Adaptability – Remains effective and resilient in a rapidly changing environment, adjusting priorities and approaches in response to evolving program and portfolio needs.
  
• Collaborates – Builds productive relationships across functions, fosters an inclusive and supportive team environment, and leverages diverse expertise to achieve shared goals.
  

Knowledge & Experience (essential)

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• Experience sup