Key Accountabilities:
- Develop study documentation including study protocols, investigators brochures (IBs), informed consent documents, and clinical dossiers for regulatory submissions
- Provide scientific input into documentation including IBs, IMPDs, DSURs, and CSRs
- Review study data (safety and efficacy) for accuracy and quality
- Triage and delegate work requests to in-house SMEs; manage timeline, resources, and workload
- Collaborate with Clinical Operations, Medical Affairs, and asset matrix teams to ensure compliance with organizational SOPs
- Participate in Steering Committees and Advisory Boards with global thought leaders as needed
- Provide senior management regular updates on clinical research progress
- Review imaging studies; provide input on interpretation, quality assurance, accuracy, and final review of imaging materials prior to implementation
- Coordinate clinical imaging, pharmacology, biostatistics, and physics SMEs to address complex trial questions/strategy
Education and Experience / Qualifications:
- University degree with MD required
- 10+ years clinical experience with strong sponsor or CRO experience required
- 5+ years 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 oncology training
- Experience managing groups within matrix teams
Personal Attributes / Skills:
- Plan and execute multiple projects under tight timelines; strong attention to detail
- Prioritize and manage time effectively; strong organizational and interpersonal skills
- Proficiency in Microsoft Office (Outlook, Word, PowerPoint, Excel)
- Excellent oral and written communication; manage teams through complex issues
- Ability to communicate with multiple stakeholders