5AM Ventures

Medical Director

• Design and implement scalable clinical operations processes, governance structures, vendor oversight models, and study management practices.
• Establish the framework for how Renasant executes clinical trials as the organization grows.
• Evaluate which functions should be maintained internally and which should be outsourced to CROs and specialized vendors.
• Support future hiring plans and organizational design for Clinical Operations.
• Support clinical studies involving genetically defined patient populations and genetic confirmation of diagnosis.
• Develop operational approaches for patient identification, screening, and enrollment in rare disease populations.
• Establish relationships with nephrology investigators, rare disease centers of excellence, patient advocacy organizations, and specialty testing partners.
• Support global recruitment strategies where patient populations may be geographically dispersed.
• Lead selection, oversight, and performance management of CROs, central laboratories, genetic testing vendors, imaging vendors, and specialty providers.
• Establish clear governance structures and accountability measures for external partners.
• Ensure external partners function as extensions of the Renasant team while maintaining high standards of quality, speed, and execution.
• Serve as the primary Clinical Operations leader responsible for transitioning programs from preclinical and translational development into clinical execution.
• Partner with DMPK, Toxicology, and Research teams to develop operationally feasible clinical development plans.
• Identify operational risks, and execution challenges before studies enter the clinic.
• Provide operational input into protocol development, patient identification approaches, and study feasibility.
• Build operational strategies for first-in-human and proof-of-concept studies.
• Lead feasibility assessments, country selection, site identification, enrollment planning, and vendor selection activities.
• Develop study timelines, budgets, risk mitigation plans, and execution strategies.
• Oversee and execute study startup through database lock and study closeout.

Director/Senior Director, Clinical Operations