Biomarker and Precision Medicine Lead

Sanofi•Cambridge, MA

3d•Onsite

About The Position

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.

Requirements

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
Bachelor’s degree plus minimum 15 years of relevant experience in an academic or biopharmaceutical setting OR Master’s Degree plus minimum 12 years post MS degree relevant experience in an academic or biopharmaceutical setting OR Ph.D. plus a minimum of 10 years post PhD relevant experience in an academic or biopharmaceutical setting.

Nice To Haves

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

Responsibilities

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 lead 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