Senior Scientist, Biomarker Operations

Ipsen; Paris; Sur place; EUR 90 000 - 120 000; Plein temps

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.

Connaissances

Biomarker Ops

Study Coordination

Vendor Management

Biospecimen Mgmt

IHC Assays

GxP Knowledge

Stakeholder Mgmt

Cross-functional

Formation

Bachelor's in Life Sciences

Advanced degree preferred

Description du poste

WHAT - Summary & Purpose Of The Position

To provide operational leadership and tissue biomarker expertise to support the successful execution of biomarker activities across Oncology and Rare Disease clinical development programs. The role is responsible for coordinating biomarker operational activities throughout the study lifecycle, including biospecimen management, assay implementation, vendor oversight, documentation, quality, and inspection readiness, while serving as a subject matter expert for immunohistochemistry (IHC)-based biomarker strategies and assays.

Working closely with Clinical Biomarker Leads, Clinical Operations, external laboratories, and study teams, this individual ensures the efficient delivery of biomarker objectives through robust operational processes, effective stakeholder management, and high-quality execution. The role contributes to the continuous improvement, standardization, and scalability of biomarker operations and tissue biomarker practices across the portfolio.

WHAT - Main Responsibilities & Technical Competencies

Biomarker Operations Leadership

• Lead biomarker operational activities across assigned clinical studies from study start‑up through study 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 appropriate documentation, eTMF management and compliance with applicable procedures and quality standards.

Vendor Management and Study Delivery

• 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.

Tissue Biomarker Support

• 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 operational feasibility.
• Collaborate with Biomarker Leads, Pathologists and external laboratories to ensure successful assay deployment.

Continuous Improvement

• Contribute to the 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.

Level of Responsibility

• Operates with a high degree of independence in managing biomarker operational activities across assigned studies.
• Accountable for delivery of biomarker operational plans, sample management activities and vendor coordination.
• Works in partnership with Clinical Biomarker Leads, who retain responsibility for overall biomarker strategy and scientific direction.
• Independently resolves operational challenges and escalates strategic, scientific or portfolio‑level decisions as appropriate.

HOW - Behavioural Competencies Required

Ensures Accountability

• Takes ownership for delivery of biomarker operational activities, vendor oversight, sample management processes, and study milestones. Consistently delivers high‑quality outcomes while managing competing priorities and timelines.
• Builds productive partnerships across Clinical Biomarkers, Clinical Operations, Data Management, external laboratories, CROs, and study teams to ensure successful execution of biomarker activities.

Communicates Effectively

• Clearly communicates operational risks, issues, requirements, and solutions to both technical and non‑technical stakeholders. Ensures alignment across internal and external partners.

Manages Complexity

• Navigates multiple studies, vendors, assay platforms, and operational processes simultaneously. Uses sound judgement to resolve issues and drive efficient study execution in a complex clinical development environment.

Drives Results / Continuous Improvement

• Identifies opportunities to improve biomarker operational processes, standardize workflows, and enhance efficiency, quality, and scalability across the biomarker function.

HOW - Knowledge & Experience

Knowledge & Experience (essential)

• Experience supporting biomarker activities within clinical development programs, including responsibility for operational delivery across one or more clinical studies.
• Demonstrated experience managing biomarker vendors, testing laboratories, or external service providers to deliver high‑quality study outcomes.
• Experience coordinating biospecimen management activities throughout the clinical 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, assay documentation, 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.
• Experience collaborating effectively within multidisciplinary and global teams.
• Knowledge of tissue biomarker workflows and immunohistochemistry (IHC) assay implementation in clinical development settings.
• Experience contributing to process improvement, standardization, or operational excellence initiatives.

Knowledge & Experience (preferred)

• Experience supporting oncology clinical development programs.
• Experience with tissue‑based biomarkers, digital pathology, or translational biomarker technologies.
• Experience with assay validation, assay transfer, and external laboratory oversight.
• Familiarity with rare disease clinical development.
• Experience supporting global, multicenter clinical studies.
• Experience with biomarker data review and interpretation in partnership with scientific and clinical teams.
• Experience contributing to biomarker operational strategy, capability building, or implementation of new technologies.

Education / Certifications (essential)

• Bachelor's, Master's, or equivalent degree in Life Sciences, Biomedical Sciences, Immunology, Pathology, Molecular Biology, Biochemistry, or a related scientific discipline.

Education / Certifications (preferred)

• Advanced degree (MSc, PharmD, or PhD) in a relevant scientific discipline.

Language(s) (essential)

• Fluent English, both written and verbal.

Language(s) (preferred)

• Fluent in French, both written and verbal.