Bioanalysis and Biomarker Outsourcing Manager

Sanofi•Morristown, MA

1d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Experience overseeing and managing external vendors and outsourced study activities is highly desirable.

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.