The Director/Senior Director will be responsible for developing strategy, and managing the subsequent design, execution, medical monitoring, interpretation and presentation of clinical trials associated with assigned development products.
Key Responsibilities include:
- Design and execution of clinical development plans and protocols for clinical trials in chronic hepatitis B (CHB)
- Serving as a clinical point of contact for senior management and senior level teams, both internally and externally for clinical development
- Support for clinical development discussions at regulatory interactions, leading the development of the clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses
- Leadership support / oversight of evidence generation activities to assure patient safety and study delivery
- Providing medica