Biomarker & Bioanalysis Outsourcing Lead

Sanofi; Cambridge (MA); On-site; USD 122,000 - 177,000; Full time

Benefits offered by this job

Parental leave (14 weeks)

Health and wellbeing benefits

Job summary

Sanofi is seeking a Bioanalysis and Biomarker Outsourcing Manager in Cambridge, MA to oversee outsourced bioanalytical and biomarker activities across study execution, ensuring quality and timelines. The role collaborates with Biomarker teams, external vendors, and internal stakeholders to drive data-driven decisions and maintain regulatory compliance.

The ideal candidate has 5+ years in pharmaceutical/biotech/CRO settings, strong GxP knowledge, and proven project-management skills to lead

Qualifications

• Bachelor's degree required; Master's or Ph.D. preferred in Biology, Biochemistry, Pharmacology, or related field.
• Minimum of 5 years of experience in the pharmaceutical, biotechnology, or CRO industry.
• Experience in regulated bioanalysis, clinical biomarker development, translational medicine, or related field preferred.
• Demonstrated understanding of GxP requirements and experience with outsourced laboratory or clinical research providers.
• Strong project management, organizational, and problem-solving skills with ability to manage multiple priorities.

Responsibilities

• Partner with Biomarker and Precision Medicine teams to develop biomarker strategies for clinical studies.
• Lead external biomarker activities and oversight of outsourced studies.
• Support budget forecasting, planning, tracking, and management for biomarker operations.
• Identify, evaluate, and onboard external vendors for specialized analytical services; provide scientific oversight.
• Oversee outsourced biomarker, PK and ADA bioanalytical activities to ensure timely, high-quality data.
• Interface with Regulatory Agencies, external vendors, and internal stakeholders for inspections and submissions.

Skills

Project management

Stakeholder management

Regulatory knowledge

Biomarker analysis

GxP knowledge

Communication

Education

Bachelor's degree

Master's degree

PhD

Job description

Sanofi is seeking a Bioanalysis and Biomarker Outsourcing Manager in Cambridge, MA to oversee outsourced bioanalytical and biomarker activities across study execution, ensuring quality and timelines. The role collaborates with Biomarker teams, external vendors, and internal stakeholders to drive data-driven decisions and maintain regulatory compliance.

The ideal candidate has 5+ years in pharmaceutical/biotech/CRO settings, strong GxP knowledge, and proven project-management skills to lead