Biomarker & Bioanalysis Outsourcing Lead

Socket.dev; Cambridge (MA); On-site; USD 122,000 - 177,000; Full time

Job summary

Sanofi in Cambridge, MA seeks a Bioanalysis and Biomarker Outsourcing Manager to oversee outsourced biomarker and bioanalytical activities across preclinical and clinical studies. You will manage external vendors, ensure data quality, and collaborate with internal teams to meet timelines and budgets.

The role requires strong knowledge of GxP, experience with outsourced CROs, and excellent communication and stakeholder management to drive high-quality outcomes.

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.

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.
• Oversee outsourced biomarker, pharmacokinetic (PK) and anti-drug antibody (ADA) bioanalytical activities.

Job description

Sanofi in Cambridge, MA seeks a Bioanalysis and Biomarker Outsourcing Manager to oversee outsourced biomarker and bioanalytical activities across preclinical and clinical studies. You will manage external vendors, ensure data quality, and collaborate with internal teams to meet timelines and budgets.

The role requires strong knowledge of GxP, experience with outsourced CROs, and excellent communication and stakeholder management to drive high-quality outcomes.