Head of Biospecimen Management
- Biospecimen Management is a global team and, within the Translational Medicine Unit, part of Operations. The team is responsible for sample collection, handling, and logistics of samples that are collected for pharmacokinetic, immunogenicity, or biomarker analyses in Sanofi's clinical trials.
- Leads a global team that supports all aspects of sample management for clinical trials of all phases.
- Supports some aspects of the management of pre-clinical biospecimens.
- Responsible for the strategy of Biospecimen Management for biomarkers and bioanalysis.
- Oversees the activities of the biospecimen management team:
- Implementing the translational medicine strategy (e.g., Biomarker/Companion Diagnostics, pharmacokinetic, anti-drug antibodies) of clinical trials, focusing on biospecimen operations.
- Reviewing clinical trial protocols and Informed Consent Forms to ensure that the collection and analysis of biological samples are conducted according to the protocol and the biomarker plan, and in alignment with regulatory guidance.
- Preparation of study-related documents, e.g. Study Sample Management Plan.
- The entire business process of biospecimen lifecycle, ensuring that samples are collected, shipped, processed, analyzed, and stored with the highest degree of quality and in compliance with applicable regulations.
- Tracking and managing all sample related activities for PK, PD, and biomarkers; supporting discrepancy resolution between CL and BA laboratory.
- Setting up the analytical Laboratory Information Management System software to register biospecimen of clinical trials to be prepared for analysis.
- Registering of samples, label preparation, correct storage, and compliant destruction.
- Accountable for quality and compliance in the handling of clinical samples; assures accuracy of sample delivery for analysis.
- Supports the management of 'precious' samples and samples for future use.
- Works with local teams to manage clinical samples according to health authority guidelines and quality requirements defined in GLP/GCP.
- Liaises with the clinical study organization, bioanalytical experts, and external partners (e.g., CRO, analytical labs) to ensure cross-functional alignment, and adherence to deliverables and timelines.
- Develops productive working relationships with central labs, ensuring the shipping, delivery, and quality of biospecimen fulfil Sanofi expectations.
- Master’s Degree in a biomedical science or related discipline and 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
- Basic knowledge of data management and process optimization through digitization and AI applications
- Technical skills:
- 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.
- Soft skills:
- Excellent communication skills
- Mind set for high quality
- Respectful of timelines
- Collaborative team worker
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