Role Responsibilities:
- Create fit-for-purpose imaging biomarker strategies and develop imaging endpoints to advance the clinical pipeline.
- Prepare and present clinical imaging strategies to senior management.
- Manage complex stakeholder networks.
- Lead, design, and implement multi-modality imaging measures as endpoints for oncology therapeutic clinical studies.
- Serve as imaging subject matter expert to ensure optimal design/execution, including protocols, imaging endpoints, imaging manuals/charters, statistical analysis plans, and clinical study reports.
- Partner with Clinical Imaging Operations and imaging CROs to ensure flawless imaging conduct and data integrity.
- Serve as Study Scientific Director for trials focused on qualification and utilization of novel imaging biomarkers.
- Lead regulatory agency communications regarding imaging endpoints, procedures, and approval discussions with site ethics committees.
Qualifications / Required Skills:
- PhD with 10+ years of clinical imaging experience (7+ years in oncology drug development).
- Superior written/verbal communication and organizational skills.
- Experience implementing central efficacy assessments using RECIST 1.1, iRECIST, PCWG3, Lugano, and IMWG.
- Successful regulatory agency engagement; ability to champion imaging innovations and lead projects effectively.
- Experience as Study Scientific Director for PET imaging biomarker clinical trials in oncology.
- Experience applying PET imaging as a quantitative endpoint in oncology clinical and preclinical studies.