Clinical Imaging Scientific Director (Oncology)

About the role

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 ethics committees for approval of clinical imaging biomarker development studies.

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 ethics committees for approval of clinical imaging biomarker development studies.

Requirements

• PhD program with a minimum of 10+ years of clinical imaging experience (minimum of 7 years within oncology drug development).
• Superior written/verbal communication and organization skills.
• Experience implementing central efficacy assessments using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano and IMWG in oncology clinical trials is needed.
• We also are looking for you to have had successful engagement experience with regulatory agencies and the ability to champion imaging innovations and lead projects effectively.
• 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.

Qualifications

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

Skills

• Superior written/verbal communication and organization skills.
• Experience implementing central efficacy assessments using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano and IMWG in oncology clinical trials.
• 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.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$205,000.00 - $341,600.00 annually

Schedule

Full time