Bioanalysis and Biomarker Outsourcing Manager

Key Responsibilities

• 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.

Ideal Candidate

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.

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.