Study-level Clinical Development Leadership
· Collaborate with Clinical Scientist(s) to provide clinical leadership across 2-3 study team(s) that is scientifically rigorous and aligns with company objectives.
· Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring.
· Lead peer-to-peer interactions with investigators.
· Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities.
· Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team.
Strategic Guidance, Clinical Insights & Interpretation
· Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.
· Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.