- Provide clinical and scientific input to study design, protocol development, statistical analysis plans, and reporting.
- Maintain medical strategic oversight and accountability for clinical trial design and regulatory documents.
- Provide clinical leadership for trial execution, including recruitment, site activation, and data management in compliance with GCP and regulatory standards.
- Engage with external opinion leaders and investigators to ensure successful study design and implementation.
- Monitor the competitive landscape and regulatory environment to guide strategic program direction.
- Prepare clinical sections of regulatory documents, including Investigator Brochures, IND sections, and Clinical Study Reports.
- Represent the company at investigator meetings, site initiation visits, and scientific conferences.
GCP