Associate Director, Clinical Imaging (Oncology)

Regeneron Pharmaceuticals•Boston, MA

About The Position

At Regeneron, the Associate Director, Clinical Imaging (Oncology) leads the strategy and execution of complex early- and late-phase oncology imaging in clinical trials where imaging plays a key role. The role covers all imaging modalities, with a special focus on PET and CT, and champions imaging endpoints and biomarkers, scientific imaging, and tumor response assessment in oncology studies. The successful candidate is an independent imaging scientific leader and member of cross-functional program teams, working 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 position is preferably based on-site at Regeneron’s Tarrytown, New York offices four days per week, but remote work may be considered 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 in clinical trials.
Successful engagement experience 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 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 in oncology clinical studies.
Serve as an imaging subject matter expert to clinical teams, supporting the design and execution of imaging strategies, 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 effective conduct and data integrity for imaging components and endpoints.
Serve as Study Imaging Director on clinical trials focused on qualification and use of novel imaging biomarkers.
Design and implement novel PET, immuno-PET, and other novel imaging agents or biomarkers in oncology clinical trials.
Lead interactions with regulatory agencies concerning 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 may include medical, dental, vision, life, and disability coverage, 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.

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