Director – Clinical Imaging Operations
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Berkeley Heights, NJ, USA, Tarrytown, NY, USA |
| Salary | $202000 – $336600 |
| Type | Full-Time |
| Degrees | Bachelor’s, PhD |
| Experience Level | Expert or higher |
Requirements
- BA/BS or PhD (engineering/biology/imaging fields preferred)
- 10+ years of clinical imaging experience as applied to drug development
- Knowledge of CT, PET, US, and MRI imaging acquisition & analysis techniques
- Experience in GCP clinical imaging as a quantitative endpoint in clinical studies
- Experience in clinical imaging operations
- Experience in regulatory interactions and submissions
- Familiarity with modern clinical imaging scanners
Responsibilities
- Lead and develop the Clinical Imaging Operations function with supervision of multiple direct reports
- Liaise and coordinate activities across collaborator functions, such as Data Management, Global Procurement (GP), Clinical Trial Management (CTM) and Vendor Relationship Management (VRM)
- Liaise with imaging scientific leads to ensure operational feasibility and execution of imaging strategies
- Collaborate with VRM and GP in imaging vendor oversight and performance management
- Design and implement imaging operational procedures across all therapeutic areas and imaging modalities
- Author, review and approve Imaging Manuals, Communication Plans, study document templates and SOPs
- Support regulatory interactions and inspection activities related to clinical imaging
- Coordinate, review, serve as escalation point and troubleshoot imaging procedures related to study startup
- Track imaging progress across multiple clinical studies and address imaging issues
- Lead internal and external collaborative activities related to the development of new technologies and innovative approaches to increase operational efficiency
- Lead process improvement initiatives to create efficiencies in the implementation of operations aspects of imaging throughout the lifecycle of studies
Preferred Qualifications
- Extensive experience managing direct reports
- Excellent relationship management skills
- Outstanding written and verbal communication skills
- Proven organizational capabilities and experience
- Ability to work in fast-paced and dynamic environment