Clinical Imaging Scientific Director (Oncology)
About The Position
The Clinical Imaging Scientific Director for Oncology will own the strategy and execution of sophisticated early and late phase oncology imaging in clinical trials where imaging plays a key role. Imaging includes all modalities with a special focus on PET and CT. In this role, you will champion the development of imaging endpoints and biomarkers and drive the scientific imaging aspects as well as tumor response assessment of oncology clinical studies. The successful candidate will be an independent imaging scientific leader and a member of cross-functional program teams including Regeneron clinical and preclinical colleagues as well as external academic and industry partners. This position provides excellent opportunities to develop innovative imaging endpoints and biomarkers in support of clinical development and contribute to bringing new treatment options to patients.
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.
- Successful engagement experience 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 studies in Oncology.
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
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
