Senior Principal Scientist

Overview

Senior Principal Scientist - Clinical Biomarker Lead, Oncology/Rare Disease. Develop and lead clinical biomarker strategies to enable data-driven decisions across clinical development and maximize Ipsen's portfolio value. Serve as a strategic partner to cross-functional teams, ensuring robust biomarker approaches aligned with program objectives and regulatory considerations.

Responsibilities

• 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 efficacy assessment across clinical development.
• Provide strategic leadership for biomarker data generation from early clinical development through late-stage and registration-enabling studies.
• Select and apply biomarker technologies and analytical approaches (cellular, tissue-based, genomic, transcriptomic, proteomic, and emerging platform technologies) to address program objectives.
• 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, communicating biomarker strategies, risks, opportunities, and key findings.
• Manage biomarker budgets, contracts, timelines, and outsourcing activities in accordance with Ipsen processes and standards.
• Maintain knowledge of emerging biomarker science, diagnostic technologies, and regulatory expectations relevant to biomarker and precision medicine development.
• Ensure compliance with applicable regulations, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Ipsen SOPs.

Qualifications

• Essential - PhD in Immunology, Oncology, Life Sciences, or related discipline (equivalent combinations considered). Strong experience supporting biomarker activities in clinical development; design and implementation of biomarker plans within clinical studies.
• Strong understanding of translational science and the role of biomarkers in informing target engagement, pharmacodynamic activity, mechanism of action, patient stratification, efficacy, and safety.
• Experience applying biomarker technologies across tissue-based, cellular, genomic, transcriptomic, and proteomic platforms; knowledge of biomarker assay development and validation.
• Excellent written and verbal communication; ability to convey complex scientific concepts to technical and non-technical audiences. Experience in oncology and/or rare disease drug development is preferred.

• Preferred - Demonstrated experience developing and executing biomarker strategies with influence on development decisions; integrating biomarker data into clinical strategies; cross-functional collaboration; experience managing CROs and external partners; knowledge of regulatory documentation related to biomarkers; experience supporting late-stage or registration-enabling programs.
• Education / Certifications (essential) - PhD in Immunology, Oncology, Life Sciences, or related discipline. Equivalent combinations may be considered.
• Education / Certifications (preferred) - PhD with post-doctoral studies in Immunology or Oncology.
• Language(s) (essential) - English: business level (oral and written).
• Language(s) (preferred) - French: business level (oral and written).

Work Environment & Commitment

We are an inclusive organization committed to equal opportunities and creating a workplace where everyone feels heard, valued, and supported. We provide adjustments or support during the application process if needed. At Ipsen, each employee makes a real impact, and teams work on life-changing projects that benefit patients and society.