Clinical Imaging Scientific Director (Oncology)

Role Summary

The Clinical Imaging Scientific Director for Oncology will own the strategy and execution of complex early through late-phase oncology imaging in clinical trials where imaging plays a key role. Imaging includes all modalities with a special focus on PET and CT. The role champions the development of imaging endpoints and biomarkers and drives the scientific imaging aspects as well as tumor response assessment of oncology clinical studies in partnership with clinical sciences and preclinical research teams.

Responsibilities

• Create fit-for-purpose imaging biomarker strategies and work closely with research, clinical imaging and the oncology therapeutic area for the development of imaging endpoints to inform and advance the Regeneron clinical pipeline.
• Prepare and present clinical imaging strategies to senior management.
• Manage a complex network of stakeholders across Regeneron.
• Lead, design and implement multi-modality imaging measures as endpoints for oncology therapeutic clinical studies.
• Collaborate closely with Regeneron clinical teams as imaging subject matter expert to ensure optimal design and execution of imaging strategy including development of protocols, imaging endpoints, imaging manuals, imaging charters, statistical analysis plans and clinical study reports.
• Work closely with Clinical Imaging Operations and imaging contract research organizations to ensure the flawless conduct and data integrity of studies’ imaging components and endpoints.
• Serve as Study Scientific Director for clinical trials focused on qualification and utilization of novel imaging biomarkers.
• Lead the interaction with regulatory agencies for communications regarding imaging endpoints and procedures.
• Lead the interaction with regulatory agencies and site ethic committees for approval of clinical imaging biomarker development studies

Qualifications

• Experience as study scientific director of PET imaging biomarker clinical trials in Oncology.
• Experience applying PET imaging as a quantitative endpoint in clinical and preclinical studies in Oncology.
• People management experience.
• Direct experience with preclinical oncology imaging models using PET and immuno-PET imaging biomarkers.
• Strong background in oncology, biology, molecular imaging, radiopharmceuticals and familiar with precision medicine approaches.
• Imaging CRO oversight and implementation of quality control procedures.

Skills

• Core expertise in oncology imaging and biomarker development
• Strategic imaging trial design and endpoint development
• Regulatory engagement and communications
• Cross-functional collaboration and stakeholder management

Education

• PhD with a minimum of 10+ years of clinical imaging experience (minimum of 7 years within oncology drug development).

Additional Requirements

• Experience implementing central efficacy assessments using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano and IMWG in oncology clinical trials is required.