As the Head of Biospecimen Management at Sanofi, you will lead a global team responsible for managing biospecimens vital for clinical trials. Your expertise will ensure compliance and quality in the handling of samples, aligning cross-functional teams towards successful project outcomes.
Key Responsibilities
Lead a global team supporting all aspects of sample management for clinical trials
Manage pre-clinical biospecimens
Develop strategy for Biospecimen Management for biomarkers and bioanalysis
Oversee biospecimen management team activities
Implement translational medicine strategy focusing on biospecimen operations
Review clinical trial protocols and Informed Consent Forms
Prepare study-related documents
Ensure compliance with biospecimen lifecycle regulations
Track and manage sample-related activities for PK, PD, and biomarkers
Set up and manage Laboratory Information Management System
Ensure accuracy of sample delivery for analysis
Support management of 'precious' samples
Liaise with clinical study organization and external partners
Develop relationships with central labs
Required Qualifications
Master’s Degree in a biomedical science or related discipline
5 plus years of people management experience in a pharmaceutical environment
Practical experience in sample management
Operational experience in clinical studies
Project management experience
Hands-on experience with LIMS system, e.g. Watson
Familiar with requirements of regulatory authorities (GCP, GCLP, international guidance)
Solid understanding of the operational aspects of clinical trials
Knowledge of biomarkers, PK, ADA, and bioanalysis
Preferred Qualifications
Basic knowledge of data management and process optimization through digitization and AI applications