Senior Principal Scientist, Clinical Biomarkers

Title:

Company:

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas:
Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Job Description:

Job Title:

Clinical Biomarker Lead Senior Scientist

Division / Function:

Early Development Translational Sciences

Location:

London

WHAT -
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 Ipsens 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 Ipsens biomarker capabilities across therapeutic areas.

WHAT -
Main Responsibilities & Technical Competencies

• Develop and lead clinical biomarker strategies across Ipsens 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…