- Serve as the primary medical point of contact for investigators, regulatory agencies, and internal and external teams, providing consistent protocol interpretation and addressing medical inquiries.
- Monitor clinical trials and Expanded Access Programs for participant safety, data accuracy, protocol compliance, and timely resolution of medical issues.
- Participate in investigator discussions during site selection and lead calls reviewing inclusion and exclusion criteria.
- Act as the primary medical expert for the protocol and support understanding and adherence across investigators, study teams, and stakeholders.
- Review documentation and reporting of adverse events, serious adverse events, and other safety events, and provide causality assessments.
- Work with Data Monitoring and Safety Boards and safety committees to provide safety oversight and evaluate ongoing trial data.
- Train and support investigators, site staff, and internal and external teams on protocol requirements and study medical and scientific objectives.
- Participate in investigator meetings, site initiation visits, and study training to present protocol details and address medical concerns.
- Lead development of protocols, treatment guidelines, and project documents, providing medical input on design, endpoints, criteria, and methodology.
- Oversee protocol adherence, manage deviations, collaborate with clinical operations, regulatory, project management, and pharmacovigilance teams, and represent Medical Affairs in proposals and client and scientific discussions.
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