- Serve as the clinical lead for one or more clinical programs, managing trial design, execution, and milestone delivery.
- Develop clinical plans, protocols, and study-related documentation.
- Provide medical oversight for Phase 2/3 and registrational studies to ensure patient safety and data integrity.
- Partner with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory to drive execution.
- Act as medical monitor for assigned studies, conducting safety surveillance and benefit-risk assessments.
- Contribute to global regulatory strategy and author clinical sections of regulatory submissions.
- Present clinical data and strategy to health authorities and senior leadership.
- Collaborate with internal teams and KOLs to align development strategy with launch needs.
GCP