Bioanalysis and Biomarker Outsourcing Manager

Job description

Job title: Bioanalysis and Biomarker Outsourcing Manager Location: Cambridge, MA About the Job This position within Translational Medicine Unit operations group is for a Bioanalysis and Biomarker Outsourcing Manager with expertise in preclinical and clinical bioanalysis and biomarker analysis, and clinical operations. The successful candidate will be responsible for overseeing outsourced bioanalytical and biomarker activities across all stages of study execution, ensuring high-quality deliverables, operational excellence, and effective collaboration with internal stakeholders and external partners. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. 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. Main Responsibilities Key responsibilities include: Partner closely with Biomarker and Precision Medicine teams to develop and execute biomarker strategies and plans for clinical studies. Serve as the primary point of contact for externally conducted biomarker activities, enabling informed, data-driven decision-making across study teams. Support budget forecasting, planning, tracking, and management to provide clear visibility into biomarker operations and their impact on project objectives, timelines, and resource allocation. Identify, evaluate, and onboard external vendors for specialized analytical services, providing scientific and technical oversight as needed. Serve as the project manager for the externalization and operationalization of biomarker and bioanalytical activities supporting preclinical and clinical drug development programs. Work closely with vendors to ensure studies are executed according to agreed timelines, budgets, scientific objectives, and quality standards. Oversee outsourced biomarker, pharmacokinetic (PK) and anti-drug antibody (ADA) bioanalytical activities. Monitor assay development, validation, and sample analysis activities to ensure the timely delivery of high-quality data in compliance with applicable regulatory requirements and industry standards. Support data reconciliation, review, and import processes to ensure data integrity and readiness for downstream analyses. Collaborate with Central Laboratories, sample management teams, and clinical operation teams to ensure study sample collection, handling, logistics, storage, and tracking activities meet protocol requirements and operational timelines. Lead and support vendor contracting activities, including the development of Requests for Information (RFIs), Requests for Proposal (RFPs), contract negotiations, and ongoing vendor governance. Build and maintain strong partnerships with Procurement, Legal, Finance, and other cross-functional stakeholders. Partner with Quality Assurance to prepare for, support, and respond to audits, ensuring external vendors maintain compliance with Sanofi quality standards and applicable regulatory requirements. Interface with Regulatory Agencies, external vendors, and internal stakeholders to support regulatory inspections, inquiries, and submissions, and documentation related to biomarker and bioanalytical activities. The ideal candidate will possess a strong understanding of biomarker and bioanalytical technologies, along with extensive experience in preclinical and clinical sample analysis. They should have a solid knowledge of GxP regulations and quality standards and be able to proactively identify, troubleshoot, and resolve issues related to studies conducted at external vendors. The candidate must demonstrate excellent communication, collaboration, and stakeholder management skills, with the ability to work effectively across multidisciplinary teams and interact with a broad range of internal clients, external partners, and support functions. They should be adept at driving streamlined processes while maintaining a strong focus on quality, compliance, and timely execution. The successful candidate will be responsible for building and maintaining effective vendor relationships, ensuring study objectives are clearly communicated and executed, and that vendor performance meets project expectations. Experience overseeing and managing external vendors and outsourced study activities is highly desirable. About You Basic Qualifications Bachelor's degree required, Master's, or Ph.D. degree preferred in Biology, Biochemistry, Pharmacology, or a related scientific discipline. Minimum of 5 years of experience in the pharmaceutical, biotechnology, or contract research organization (CRO) industry. Experience in regulated bioanalysis, clinical biomarker development, translational medicine, or a related field is strongly preferred. Demonstrated understanding of GxP requirements and experience working with outsourced laboratory or clinical research service providers. Strong project management, organizational, and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment. Why 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. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. Help improve the lives of millions of people globally by making drug development quicker and more effective. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; 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. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress, discover extraordinaryBetter 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. Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, ge