Clinical Biomarker Lead, Senior Scientist

Title:

Clinical Biomarker Lead Senior Scientist

Company:

Ipsen Innovation (SAS)

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!

For more information visit us at follow our latest news on LinkedIn and Instagram.

Job Description:

Job Title:

Clinical Biomarker Lead Senior Scientist

Division / Function:

Early Development Translational Sciences

Location:

London or Paris

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 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.

HOW - Behavioural Competencies Required

• 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.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Experience supporting biomarker activities across clinical development including 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 a range of biomarker technologies and platforms including tissue-based cellular genomic transcriptomic and proteomic approaches.
• Knowledge of biomarker assay development fit-for-purpose validation analytical performance assessment and data quality requirements for clinical studies.
• Strong scientific problem-solving skills with the ability to critically evaluate opportunities risks and evidence to support practical decision-focused biomarker strategies.
• Excellent written verbal and presentation skills with the ability to communicate complex scientific concepts effectively to both technical and non-technical audiences.
• Experience in oncology and/or rare disease drug development is strongly preferred.

Knowledge & Experience (preferred):

• Demonstrated experience developing and executing biomarker strategies in pharmaceutical or biotechnology drug development with responsibility for influencing key development decisions.
• Experience integrating biomarker data into clinical development strategies and communicating biomarker insights to multidisciplinary teams and senior stakeholders.
• Experience working within cross-functional matrix teams and collaborating effectively with Clinical Development Clinical Operations Biostatistics Regulatory Affairs Translational Medicine and external partners.
• Working knowledge of drug development clinical trial design and applicable GxP requirements relevant to biomarker implementation.
• Experience selecting and managing CROs external laboratories and other scientific partners to deliver high-quality biomarker data.
• Experience supporting late-stage or registration-enabling clinical development programs is preferred.
• Experience contributing to regulatory submissions health authority interactions or biomarker-related regulatory documentation is preferred.

Education / Certifications (essential):

• PhD in Immunology Oncology Life Sciences or a related scientific discipline.
• Equivalent combinations of education scientific training and relevant industry experience may be considered.

Education / Certifications (preferred):

• PhD and 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

#LI-MM1 #LI-hybrid

Nous nous engageons à créer un lieu de travail où chacun se sent écouté valorisé et soutenu où nous incarnons The Real Us*. La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de linclusion et de légalité des chances. Lorsque nous intégrons des modes de pensée diversifiés nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin daménagements ou daide pendant le processus de candidature veuillez en informer léquipe de recrutement. Ces informations seront traitées avec soin et nauront aucune incidence sur le résultat de votre candidature. *Soyons nous-même

Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1