Clinical Imaging Scientific Director (Oncology)

Regeneron Pharmaceuticals • Elizabeth, MA

2d • Hybrid

About The Position

The Clinical Imaging Scientific Director for Oncology owns the strategy and execution of sophisticated early- and late-phase oncology imaging in clinical trials where imaging plays a key role, with a special focus on PET and CT. The role champions the development of imaging endpoints and biomarkers, drives the scientific imaging aspects of oncology clinical studies, and leads tumor response assessment. As an independent imaging scientific leader, this position serves on cross-functional program teams with Regeneron clinical and preclinical colleagues and external academic and industry partners. The role offers opportunities to develop innovative imaging endpoints and biomarkers in support of clinical development and new treatment options for patients.

The position develops fit-for-purpose imaging biomarker strategies and collaborates with research, clinical imaging, and the oncology therapeutic area to advance the clinical pipeline. It leads the design and implementation of multimodality imaging measures as endpoints, advises clinical teams on imaging strategy and study design, and oversees imaging components in partnership with Clinical Imaging Operations and imaging contract research organizations. The role also serves as Study Scientific Director for trials qualifying and using novel imaging biomarkers and leads regulatory interactions related to imaging endpoints, procedures, and biomarker development studies.

The role is based in Tarrytown, New York; Cambridge, Massachusetts; or Warren, New Jersey, four days per week, with remote work also considered for the right candidate.

Requirements

• PhD and a minimum of 10 years of clinical imaging experience, including at least 7 years within oncology drug development.
• Superior written and verbal communication and organizational skills.
• Experience implementing central efficacy assessments using oncology tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano, and IMWG in clinical trials.
• Successful experience engaging with regulatory agencies.
• 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 oncology studies.

Responsibilities

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

Benefits

• Annual bonuses or other incentive plans, depending on country and role.
• Equity awards, depending on country and role.
• Pension or retirement benefits, depending on country and role.
• 401(k) company match, depending on country and role.
• Health and wellness programs, depending on country and role.
• Fitness centers, depending on country and role.
• Medical, dental, vision, life, and disability insurance benefits, depending on country and role.
• Paid time off, depending on country and role.
• Family support benefits, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree