Biomarker and Precision Medicine Lead

Job Title: Biomarker and Precision Medicine Lead

Location: Cambridge, MA

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.

Sanofi's Biomarkers & Precision Medicine group, within the Translational Medicine Unit, seeks an experienced Biomarker and Precision Medicine Lead. This data-driven position focuses on leading the development and implementation of decision enabling translational medicine strategies for our robust pipeline in Immunology and Inflammation with a specific focus on our growing pipeline in Inflammatory Bowel Disease (IBD). The role is critical in identifying and validating biomarkers that predict patient response, demonstrate molecular activity including target engagement, and correlate with clinical outcomes, as well as leading forward and reverse translational research activities in IBD.

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.

• Scientific Leadership & Strategy:
  Develop comprehensive and decision enabling biomarker and precision medicine strategies for research and development (Ph1-Ph4) projects

• Design approaches for implementing biomarkers in clinical studies using various platforms (omics, bioimaging, etc.)

• Provide scientific expertise in translating biological pathways to clinical markers and clinical markers into biological pathways

• Review and interpret complex clinical and non-clinical biomarker data sets

• Identify and validate novel biomarkers for patient selection and monitoring

• Lead cross-functional translational medicine sub-teams and coordinate the biomarker identification, assay development, implementation and execution efforts in a highly matrixed environment

• Ensure timely execution of biomarker studies within budget constraints

• Evaluate and select optimal platforms and methodologies for biomarker data generation

• Monitor study progress and troubleshoot technical challenges

• Maintain project documentation and regulatory compliance

• Author biomarker portions of clinical documents, including clinical protocols and reports, Investigator Brochures, etc.

• Work closely with global multidisciplinary teams including research scientists, clinical pharmacologists, clinicians, clinical and biomarker operations, regulatory and data scientists

• Engage with external key opinion leaders and research partners

• Initiate and lead external collaborations

• Present strategies and results at internal and external meetings

• Contribute to regulatory documents and scientific publications

• Support business development activities related to biomarker strategies

Required Qualifications:

• MD, MD/PhD, or PhD with 5+ years of industry experience in biomarker/ translational or clinical research in a global highly matrixed environment

• Demonstrated expertise in immunology and inflammation indications

• Strong understanding of biomarker development and implementation in global clinical trials for drug development

• Strong understanding of drug development and clinical trial design

• Experience with various biomarker platforms and technologies

• Proven track record in translational research

• Excellence in written and verbal communication

• Demonstrated experience in leading teams in a highly matrixed environment

Preferred Qualifications:

• Experience in Gastrointestinal diseases, preferably in IBD; additional experience in Transplantation is a plus

• Experience with bioinformatics and computational methods

• Knowledge of biomarker assay development for clinical use

• Publication record in Immunology and IBD

• Experience in regulatory interactions

• Project management certification

Experience/

Education:

• Bachelor’s degree plus minimum 15 years of relevant experience in an academic or…