Ipsen Innovation (SAS)

Job Title:Clinical Biomarker Lead, Senior ScientistDivision / Function:Early Development, Translational SciencesLocation:LondonWHAT - Summary & Purpose of the PositionTo develop and lead clinical biomarker strategies that enable data-driven decision-making across clinical development and maximize the value of Ipsen's 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 Ipsen's biomarker capabilities across therapeutic area s.WHAT - Main Responsibilities & Technical CompetenciesDevelop 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 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 RequiredCommunicates 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 & ExperienceKnowledge & 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 OncologyLanguage(s) (essential):English: Business level, oral and writtenLanguage(s) (preferred):French: Business level, oral and writtenWe are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace "The Real Us". The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.