Associate Director, Clinical Imaging (Oncology)

Regeneron Pharmaceuticals • Boston, MA

3d • $176,100 - $287,300

About The Position

At Regeneron, the Associate Director, Clinical Imaging leads strategy and execution for complex early- and late-phase oncology imaging in clinical trials, with a special focus on PET and CT. The role champions the development of imaging endpoints and biomarkers, leads scientific imaging activities, and oversees tumor response assessment in oncology studies. The successful candidate is an independent imaging scientific leader and a member of cross-functional program teams, collaborating with Regeneron clinical and preclinical colleagues and external academic and industry partners. The position offers opportunities to develop innovative imaging endpoints and biomarkers in support of clinical development and new treatment options for patients.

The preferred work arrangement is on-site at Regeneron's Tarrytown, New York offices four days per week. Remote work is also an option for an exceptional candidate.

Requirements

• PhD.
• At least 7 years of clinical imaging experience, including at least 5 years in oncology drug development.
• Experience implementing central efficacy assessments using oncology tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano, and IMWG.
• Successful experience engaging with regulatory agencies.
• Ability to champion imaging innovations and lead projects effectively.

Nice To Haves

• At least 7 years of imaging experience in oncology drug development and clinical PET tracer development in a pharmaceutical or biotechnology setting.
• Experience as study scientific director of PET imaging biomarker clinical trials in oncology.
• Experience with radiopharmaceuticals and applying imaging as a quantitative endpoint in clinical and preclinical oncology studies.
• Experience overseeing imaging CROs and implementing quality control procedures.

Responsibilities

• Create fit-for-purpose imaging biomarker strategies and work with research, clinical imaging, and oncology teams to develop imaging endpoints that inform and advance 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 clinical studies.
• Serve as an imaging subject matter expert to clinical teams, supporting study design and execution, including protocols, imaging manuals and charters, statistical analysis plans, and clinical study reports.
• Work with Clinical Imaging Operations and imaging contract research organizations to ensure conduct and data integrity of imaging study components and endpoints.
• Serve as Study Imaging Director on clinical trials focused on qualifying and using novel imaging biomarkers.
• Design and implement novel PET, immuno-PET, and other novel imaging agents and biomarkers in oncology clinical trials.
• 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 may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

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