About this role
Role Overview
- Support the design, strategy, and operationalization of clinical trials during the drug development process from Phase 0 to Phase 4
- Develop study documentation including study protocols, investigators brochures, informed consent documents, clinical dossiers for regulatory submissions
- Provide scientific input into documentation including investigators brochures, investigational medicinal product dossiers, developmental safety update reports and clinical study reports
- Review study data including safety and efficacy data for accuracy and quality
- Triage and delegate work requests to the in-house team of subject matter experts
- Work closely with Clinical Operations, Medical Affairs, and asset matrix teams to ensure compliance with organizational SOPs
- Assist in development and participate as needed, in Steering Committees and Advisory Boards with global thought leaders
- Provide senior management personnel regular updates on the progress of the clinical research
- Review imaging studies and be qualified to provide input on interpretation, quality assurance, accuracy of imaging interpretation, and final review of imaging, protocols, and imaging charters prior to implementation
- Coordinate efforts associated with clinical imaging, pharmacology, biostatistics, and physics subject matter experts to address complex trial related questions/strategy
Requirements
- Scientific background with university degree and MD required
- 10+ years Clinical experience with strong sponsor or CRO experience required
- 5+ years’ experience leading teams required
- Detailed knowledge of global clinical trial regulations
- Formal training in clinical diagnostic imaging (e.g. Radiology, Nuclear Medicine, Radiation Oncology) with Clinical Fellowship level training in Oncology associated field
- Familiarity with managing groups within matrix teams
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development