Biomarker and Precision Medicine Lead

Role Summary

Biomarker and Precision Medicine Lead — Location: Cambridge, MA. This data-driven role leads the development and implementation of decision-enabling translational medicine strategies for an Immunology and Inflammation pipeline, with a specific focus on Inflammatory Bowel Disease (IBD). The position identifies and validates biomarkers that predict patient response, demonstrates molecular activity including target engagement, and correlates with clinical outcomes, while guiding forward and reverse translational research in IBD.

Responsibilities

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

Qualifications

• Required: MD, MD/PhD, or PhD with 5+ years of industry experience in biomarker/translational or clinical research in a global highly matrixed environment
• Required: Demonstrated expertise in immunology and inflammation indications
• Required: Strong understanding of biomarker development and implementation in global clinical trials for drug development
• Required: Strong understanding of drug development and clinical trial design
• Required: Experience with various biomarker platforms and technologies
• Required: Proven track record in translational research
• Required: Excellence in written and verbal communication
• Required: Demonstrated experience in leading teams in a highly matrixed environment
• Preferred: Experience in Gastrointestinal diseases, preferably in IBD; additional experience in Transplantation is a plus
• Preferred: Experience with bioinformatics and computational methods
• Preferred: Knowledge of biomarker assay development for clinical use
• Preferred: Publication record in Immunology and IBD
• Preferred: Experience in regulatory interactions
• Preferred: Project management certification

Education

• 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.