Head of Biospecimen Management

About Sanofi:We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.About the JobBiospecimen 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.Main Responsibilities: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, analysed, 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 organisation, bioanalytical experts, and external partners (e.g., CRO, analytical labs) to ensure cross-functional alignment, and adherence to deliverables and timelines.Devolops productive working relationships with central labs, ensuring the shipping, delivery, and quality of biospecimen fulfil Sanofi expectations.About youExperience:Master's Degree in a biomedigal or related discipliine and 5 years + of leadership experience in a pharmaceutical environmentPractical experience in sample managementOperational experience in clinical studiesAt least 8 years in a pharmaceutical environmentProject management experienceSoft skills:Excellent communication skillsMind set for high qualityRespectful of timelinesCollaborative team workerTechnical skills:Familiar with requirements of regulatory authorities (GCP, GCLP, international guidance)Solid understanding of the operational aspects of clinical trialsKnowledge of biomarkers, PK, ADA, and bioanalysis.Education:Degree in a biomedical science or related disciplineLanguages:English fluent, French and German a plusWhy choose us?Bring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.Benefit from a well-thought-out benefits package that rewards your contribution and commitment.We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.Pursue Progress.

Discover Extraordinary.Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve.

Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary – together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at LI-Hybrid#Biomarkers#ClinicalStudiesSanofiSanofiCareersPursueProgressDiscoverExtraordinaryWeAreSanofiIgnitingPotentialnull