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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in oncology imaging strategies and clinical trial execution, with a strong focus on developing imaging endpoints and biomarkers. Proven ability to lead regulatory interactions and manage complex stakeholder networks in clinical research.
Highest-signal resume keywords
Oncology Imaging ExperienceClinical Trial ManagementRegulatory Agency EngagementPET Imaging Biomarker DevelopmentImaging Endpoint Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ImagingBiomarker DevelopmentRECIST 1.1 ImplementationIRECIST ImplementationPCWG3 ImplementationLugano Criteria ApplicationIMWG ApplicationQuantitative Imaging AnalysisStudy Scientific Director ExperienceMulti-Modality Imaging Design
Soft Skills
Superior Communication SkillsOrganizational SkillsProject LeadershipStakeholder ManagementChampioning Innovations
Certifications & Qualifications
PhD in Relevant Field
Industry Keywords
Oncology Drug DevelopmentClinical Imaging OperationsTumor Response AssessmentImaging ProtocolsStatistical Analysis Plans
About the role
Key responsibilities & impact- Own the strategy and execution of sophisticated early- and late-phase oncology imaging in clinical trials
- Develop imaging endpoints and biomarkers and drive scientific imaging and tumor response assessment for oncology clinical studies
- Create fit-for-purpose imaging biomarker strategies with research, clinical imaging and oncology therapeutic-area teams
- 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 the imaging subject matter expert on imaging strategies, protocols, endpoints, manuals, charters, statistical analysis plans and clinical study reports
- Work with Clinical Imaging Operations and imaging contract research organizations to ensure study imaging components and endpoint data integrity
- Serve as Study Scientific Director for clinical trials qualifying and utilizing novel imaging biomarkers
- Lead regulatory-agency interactions regarding imaging endpoints, procedures and biomarker development studies
- Lead interactions with regulatory agencies and site ethics committees for approval of clinical imaging biomarker development studies
Requirements
What you’ll need- PhD program with a minimum of 10+ years of clinical imaging experience, including a minimum of 7 years within oncology drug development
- Superior written and verbal communication and organization skills
- 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
- 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
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 for applicants with known disabilities or chronic illnesses
