At a Glance
- Tasks: Lead clinical biomarker strategies in oncology and rare diseases to drive impactful decisions.
- Company: Ipsen, a forward-thinking organisation dedicated to patient-focused innovations.
- Benefits: Inclusive workplace, equal opportunities, and support throughout the application process.
- Other info: Collaborative environment with opportunities for professional growth and influence on key decisions.
- Why this job: Make a real impact on life-changing projects that benefit patients and society.
- Qualifications: PhD in relevant field with strong experience in biomarker activities and clinical development.
The predicted salary is between 80000 - 100000 £ per year.
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
- Ph D 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) – Ph D in Immunology, Oncology, Life Sciences, or related discipline. Equivalent combinations may be considered.
- Education / Certifications (preferred) – Ph D 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.
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Senior Principal Scientist in London employer: Ipsen Biopharm Ltd
Ipsen Biopharm Ltd is an excellent employer, offering a dynamic work environment in Wrexham where innovation and compliance are at the forefront of pharmaceutical manufacturing. Employees benefit from a strong commitment to health and safety, opportunities for professional growth, and a culture that values continuous improvement and teamwork. Joining Ipsen means being part of a dedicated team that plays a crucial role in delivering high-quality drug substances while enjoying the support and resources needed to thrive in your career.
