Translational Biomarker and CDx Leader

Translational Biomarker and CDx Leader

Pierre Fabre

Toulouse, France

The successful candidate will lead clinical translational activities, with a primary focus on cancer genomics-driven biomarker and CDx strategies that enable rigorous testing of therapeutic and mechanistic hypotheses within clinical programs, from early- to late-stage clinical development.

Responsibilities:

• Develop and implement genomics-driven biomarker strategies to support patient selection and stratification in precision oncology programs. Oversee the application of NGS-based platforms and liquid biopsy technologies for biomarker discovery, MRD monitoring, and resistance profiling
• Lead CDx co-development in partnership with diagnostics companies, overseeing assay selection, analytical and clinical validation, bridging studies, and labeling strategies
• Engage cross-functionally with Clinical Development, Data Science, Biometry, PK/PD, and Regulatory teams to execute clinical biomarker plans and translational strategy, manage timelines, budgets, and risk mitigation across clinical studies
• Collaborate with clinical teams to develop comprehensive clinical documents such as study protocols and data management plans; manage internal and external resources, generate high-quality documentation for decision-making, and develop SOPs implementing best practices for genomic biomarker testing and CDx workflows
• Select and manage contract research organizations (CROs) and external testing vendors, ensuring quality clinical sample processing and timely biomarker data delivery
• Proactively monitor the external pharmaceutical and clinical landscapes, to align internal directions with emerging industry advancements and best practices in precision oncology and cancer genomics

Who you are?

Your skills at the service of innovative projects:

• PhD, MD/PhD or PharmD in cancer biology, human genetics, genomics, or molecular oncology
• 7-12 years of experience in oncology translational research within pharma, biotech, or clinical CRO settings
• Proven track record of leading translational science activities and executing clinical-grade biomarker development strategies
• Prior regulatory experience with CDx co-development
• Hands-on experience with NGS-based platforms applied to oncology biomarker discovery and clinical translation. Proven expertise in liquid biopsy technologies (ctDNA, cfDNA) and their application in early detection, MRD monitoring, and resistance profiling

Leadership Competencies:

• Demonstrate effective leadership skills with experience in leading translational projects within a multi-functional matrix environment
• Foster a collaborative and inclusive work environment through strong interpersonal and communication skills
• Employ a critical and objective approach to decision-making, grounded in science-based data and interpretation, with emphasis on applying these insights within clinical settings
• Define operational priorities and set ambitious, demanding objectives to drive success
• Promote a culture focused on achieving results to maximize the quality of deliverables
• Proactively monitor external pharmaceutical and clinical landscapes, encouraging the evolution of internal directions and approaches to align with industry advancements and best practices in precision medicine
• Excellent written and oral communication skills in English; knowledge of French is considered as a plus