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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading oncology imaging strategies and executing clinical trials, with a strong focus on developing imaging endpoints and biomarkers. Proven ability to collaborate with cross-functional teams and manage stakeholder relationships effectively.
Highest-signal resume keywords
PhDClinical Imaging ExperienceOncology Drug DevelopmentRegulatory Agency EngagementImaging Biomarker Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Imaging Endpoint DevelopmentTumor Response AssessmentRECIST 1.1IRECISTPCWG3LuganoIMWGPET ImagingQuantitative ImagingRadiopharmaceuticals
Soft Skills
Project LeadershipStakeholder ManagementCollaborationCommunication
Tools & Technologies
Imaging CRO OversightStatistical Analysis PlansClinical Study Reports
Industry Keywords
OncologyClinical TrialsBiotechnologyPharmaceuticalImaging Innovations
About the role
Key responsibilities & impact- Lead the strategy and execution of complex early- and late-phase oncology imaging in clinical trials
- Develop imaging endpoints and biomarkers and drive scientific imaging aspects and tumor response assessment of oncology clinical studies
- Participate in cross-functional program teams with Regeneron clinical and preclinical colleagues and external academic and industry partners
- Create fit-for-purpose imaging biomarker strategies and 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 multi-modality imaging measures as endpoints for oncology clinical studies
- Collaborate with clinical teams as imaging subject matter expert on imaging strategy, 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 studies
- Serve as Study Imaging Director on trials focused on novel imaging biomarkers
- Design and implement novel PET, immuno-PET and other imaging agents/biomarkers in oncology trials
- Lead regulatory-agency interactions regarding imaging endpoints, procedures and clinical imaging biomarker development studies
- Lead interactions with site ethics committees for approval of clinical imaging biomarker development studies
Requirements
What you’ll need- PhD
- Minimum of 7+ years of clinical imaging experience
- Minimum of 5 years within oncology drug development
- Experience implementing central efficacy assessments using RECIST 1.1, iRECIST, PCWG3, Lugano and IMWG in oncology clinical trials
- Successful engagement experience with regulatory agencies
- Ability to champion imaging innovations and lead projects effectively
- 7+ years of imaging experience in oncology drug development and clinical PET tracer development in a pharmaceutical/biotechnology setting preferred
- Experience as study scientific director of PET imaging biomarker clinical trials in Oncology preferred
- Experience with radiopharmaceuticals and applying imaging as a quantitative endpoint in clinical and preclinical studies in Oncology preferred
- Imaging CRO oversight and implementation of quality control procedures preferred
Benefits
Comp & perks- 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 accommodation during the recruitment process where required