Biomarker Operations Lead — Tissue & IHC Expert

Ipsen

Paris

Sur place

EUR 90 000 - 120 000

Plein temps

14 jours+

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Résumé du poste

Ipsen in Paris seeks a Biomarker Operations Leader to drive execution of biomarker activities across oncology and rare disease programs. You will coordinate biospecimen management, assay implementation, vendor oversight and study-wide documentation, ensuring quality and inspection readiness.

You will serve as the IHC biomarker SME, guiding tissue-based assays and collaborating with pathologists and external labs to enable scalable biomarker workflows and continuous process improvement across the

Qualifications

Experience supporting biomarker activities within clinical development programs and delivering operational outcomes across studies.
Experience managing biomarker vendors, testing laboratories, or external service providers.
Experience coordinating biospecimen management activities through the trial lifecycle, including sample logistics, tracking, reconciliation, biobanking, and documentation.
Working knowledge of biomarker assays and laboratory operations in a regulated clinical development environment.
Experience developing and maintaining study documentation such as laboratory manuals, sample management plans, or operational procedures.
Strong understanding of GxP principles, quality requirements, inspection readiness, and clinical trial processes.
Demonstrated ability to manage multiple priorities and stakeholders while independently resolving operational challenges.
Knowledge of tissue biomarker workflows and IHC assay implementation in clinical development settings.
Experience contributing to process improvement, standardization, or biomarker operational excellence initiatives.

Responsabilités

Lead biomarker operational activities across assigned clinical studies from study start-up through close-out.
Serve as the biomarker operations representative on cross-functional study teams.
Develop and maintain biomarker operational documents, including laboratory manuals, sample management plans and study-specific procedures.
Ensure high-quality execution of biospecimen management activities, including sample tracking, reconciliation, biobanking and sample disposition.
Maintain inspection readiness through documentation, eTMF management and compliance with procedures and quality standards.
Lead operational oversight of biomarker vendors and testing laboratories.
Coordinate biomarker activities and deliverables across internal and external stakeholders.
Monitor timelines, risks, issues and quality metrics, escalating where appropriate.
Review operational and laboratory deliverables to ensure timely and compliant execution.
Act as the study team's tissue biomarker and IHC subject matter expert.
Support implementation of tissue-based biomarker assays across clinical studies.
Provide guidance on tissue collection, handling, testing workflows and feasibility.
Collaborate with Biomarker Leads, Pathologists and external laboratories to ensure successful assay deployment.
Contribute to development and implementation of biomarker operational processes, tools, templates and best practices.
Identify opportunities to improve efficiency, quality and consistency across biomarker operations.
Support knowledge sharing and operational excellence across the Clinical Biomarkers function.