- Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
- Serve as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical/safety data and working closely with external CRO partners
- Support/manage preparation of materials for trial-related clinical committees suchs as Data Monitoring Committees, Adjucation Committees, etc.
- Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities and ethics committee/IRBs as required (e.g., Protocols, CSRs, Investigator’s Brochure, DSURs, clinical briefing documents, components of BLA/MAA submissions)
- Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications)
- Develop professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities
- Contribute to engagement with external stakeholders such as vendor thought leaders or other groups as needed including being the primary liaison with assigned individuals or groups.
- Function as an independent member of the team and represent clinical development at internal cross-functional or external meetings
- Other duties related to clinical development of EFX as assigned
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