- Development of protocols for clinical studies.
- Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
- Drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
- Monitor, review and summarize safety and efficacy data in ongoing studies.
- Represent clinical development on project teams.
- Develop relationships with appropriate consultants and external expertsand utilize these relationships to obtain feedback on protocol design.
- Clinical lead for study abstracts, posters, oral presentations and manuscripts for assigned studies.
- Serve as liaison to project teams, CRO’s, specific vendors in collaboration with Clin Operations, Clinical sub-teams, and others.
- Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest.
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