Clinical Imaging Scientific Director (Oncology)

Responsibilities

• Own the strategy and execution of sophisticated early and late phase oncology imaging, with a focus on PET and CT modalities.
• Create fit-for-purpose imaging biomarker strategies to advance the Regeneron clinical pipeline.
• Lead the design and implementation of multi-modality imaging measures as endpoints for oncology therapeutic clinical studies.
• Collaborate with clinical teams to develop protocols, imaging manuals, charters, statistical analysis plans, and clinical study reports.
• Serve as Study Scientific Director for clinical trials focused on the qualification and utilization of novel imaging biomarkers.
• Manage interactions with regulatory agencies and site ethics committees regarding imaging endpoints and procedures.
• Partner with Clinical Imaging Operations and external CROs to ensure data integrity and flawless study conduct.

Requirements

• PhD degree with a minimum of 10+ years of clinical imaging experience.
• At least 7 years of experience within oncology drug development.
• Proven expertise in implementing central efficacy assessments using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano, and IMWG.
• Experience as a study scientific director for PET imaging biomarker clinical trials in Oncology.
• Experience applying PET imaging as a quantitative endpoint in clinical and preclinical oncology studies.
• Demonstrated experience engaging with regulatory agencies to champion imaging innovations.
• Superior written and verbal communication and organizational skills.

About the Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to translate science into medicine has led to numerous FDA-approved treatments and a robust pipeline of product candidates.