Clinical Imaging Scientific Director – Oncology

This is a fully remote position, open to applicants in New Jersey, +2 more states.

📋 Description

• Take ownership of the strategy and execution of advanced early- and late-phase oncology imaging in clinical trials.

• Develop imaging endpoints and biomarkers while leading scientific imaging and tumor response evaluation for oncology clinical studies.

• Formulate tailored imaging biomarker strategies in collaboration with research, clinical imaging, and oncology therapeutic-area teams.

• Prepare and deliver presentations on clinical imaging strategies to senior management.

• Manage a complex network of stakeholders throughout Regeneron.

• Lead, design, and implement multi-modality imaging measures as endpoints for oncology clinical trials.

• Collaborate with clinical teams as the imaging subject matter expert on strategies, protocols, endpoints, manuals, charters, statistical analysis plans, and clinical study reports.

• Work in conjunction with Clinical Imaging Operations and imaging contract research organizations to ensure the integrity of study imaging components and endpoint data.

• Act as the Study Scientific Director for clinical trials that qualify and utilize novel imaging biomarkers.

• Lead interactions with regulatory agencies regarding imaging endpoints, procedures, and studies related to biomarker development.

• Facilitate communication with regulatory agencies and site ethics committees to obtain approvals for clinical imaging biomarker development studies.

⛳️ Requirements

• PhD program with a minimum of 10+ years of experience in clinical imaging, including at least 7 years in oncology drug development.

• Exceptional written and verbal communication as well as organizational skills.

• Experience in implementing central efficacy assessments utilizing RECIST 1.1, iRECIST, PCWG3, Lugano, and IMWG in oncology clinical trials.

• Proven track record of successful engagement with regulatory agencies.

• Ability to advocate for imaging innovations and effectively lead projects.

• Experience serving as the study scientific director for PET imaging biomarker clinical trials in oncology.

• Proficient in applying PET imaging as a quantitative endpoint in both clinical and preclinical oncology studies.

🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness programs.

• Fitness centers.

• Medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodations during the recruitment process for applicants with known disabilities or chronic illnesses.