Director of Clinical Biomarkers

Role Summary

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

Responsibilities

• Lead the overall biomarker strategy and execution for assigned program(s) by serving 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 preclinical to clinical transitions and align translational and biomarker strategies.
• Partner with Clinical Operations, Stats, Data Management, Project Leadership, and other teams to contribute to biomarker-related aspects of trial design and conduct, study documents, trial readouts/endpoints, and regulatory interactions.
• Manage CROs, vendors, 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 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 teams contributing to biomarker documents, plans, operations and workstreams.
• Knowledge of regulatory requirements and best practices in biomarker assay development and validation to support global clinical trials.
• Strong understanding of technology platforms and datasets, including omics, for discovery, validation and implementation of biomarkers; experience engaging vendors and CROs for biomarker assays.
• Expertise in oncology, rare disease, or immunology/inflammation.
• Ability to think critically, strategically and practically to enable decision making and influence R&D teams; proven problem solving, data analysis/interpretation and team science innovation.

Skills

• Translational science and biomarker assay development
• Clinical study design and cross-functional collaboration
• Regulatory awareness and communications for biomarkers
• Vendor and CRO management; data management and sample logistics
• Omics technologies and biomarker data interpretation

Education

• PhD, MD or equivalent in a relevant scientific discipline

Additional Requirements

• Working location: Salt Lake City / New York City / Toronto / London / Oxford; hybrid environment with 50% in office; relocation support available.