Director of Clinical Biomarkers

Role Summary

Director of Clinical Biomarkers. Lead the biomarker strategy on clinical program teams, delivering fit-for-purpose biomarker strategies including predictive and pharmacodynamic biomarker assays to support clinical decision making and the development of safe and effective medicines.

Responsibilities

• Lead the overall biomarker strategy and execution for assigned program(s) in the portfolio as the clinical biomarker lead on program/study teams.
• Develop plans to deliver fit-for-purpose pharmacodynamic, predictive, prognostic and/or other biomarker assays to support decision making in early development; collaborate with discovery teams to support transitions and align translational biomarker strategies.
• Partner with Clinical Operations, Stats, Data Management, Project Leadership, and others to contribute to biomarker-related trial design and conduct, study documents, trial readouts/endpoints and regulatory interactions.
• Manage CROs, vendors, suppliers and other groups for assay development and qualification/validation; oversee operational aspects of biomarker implementation, including sample logistics and data management.
• Stay current with emerging science and innovate with novel technologies to generate/analyze/apply data for insights on mechanisms, indications, combinations and patient selection/stratification.
• Present biomarker findings at key internal and external meetings.

Qualifications

• PhD, MD or equivalent in a relevant scientific discipline with 8+ years of biopharmaceutical industry experience in drug discovery and early development.
• Extensive experience in clinical biomarkers/diagnostics and/or translational research; strong understanding of clinical studies and cross-functional study/program teams; experience contributing to biomarker documents, plans, operations and workstreams.
• Knowledge of regulatory requirements and best practices in applying translational science and biomarker assay development/validation for global clinical trials.
• Strong understanding of technology platforms and datasets, including omics; familiarity with engaging vendors/CROs for biomarker assays.
• Expertise in oncology, rare disease, or immunology/inflammation.
• Strategic, practical thinking with ability to influence R&D teams; proven problem solving, data analysis/interpretation and team science innovation.

Skills

• Biomarker assay development and validation
• Translational science
• Cross-functional collaboration and trial design
• Regulatory understanding for global clinical trials
• Data analysis and interpretation

Education

• Doctoral-level degree (PhD) or medical degree (MD) or equivalent

Additional Requirements

• Hybrid work location: Salt Lake City / New York City / Toronto / London / Oxford; 50% in-office requirement; relocation support available.