Role Summary
Lead Biomarker and Precision Medicine efforts within the Translational Medicine Unit to develop and implement translational medicine strategies for Immunology & Inflammation programs. Identify and validate biomarkers that predict patient response, demonstrate molecular activity, and correlate with clinical outcomes. Location: Cambridge, MA; Morristown, NJ.
Responsibilities
- Develop comprehensive biomarker and precision medicine strategies for research and development 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
- Review and interpret complex clinical and non-clinical data sets
- Identify and validate novel biomarkers for patient selection and monitoring
- Lead translational medicine sub-teams and coordinate biomarker identification efforts
- 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
- Work closely with multidisciplinary teams including research scientists, clinicians, and data scientists
- Engage with external key opinion leaders and research partners
- 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: PhD with at least 5 years of experience in translational and/or clinical research. Will consider MD (or equivalent with similar skill set)
- Required: Demonstrated expertise in immunology, preferably in dermatologic and/or respiratory diseases
- Required: Strong understanding of biomarker development and implementation in clinical trials
- Required: Experience with various biomarker platforms and technologies
- Required: Proven track record in translational research
- Required: Excellence in written and verbal communication
- Preferred: Experience with bioinformatics and computational methods
- Preferred: Knowledge of biomarker assay development for clinical use
- Preferred: Publication record in relevant therapeutic areas
- Preferred: Experience in regulatory interactions