Job Title: Head of Biospecimen Management About the job: + 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. 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, 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. About You + 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 **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $172,500.00 - $287,500.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)