Director/Senior Director, Clinical Operations

At Renasant Bio, we are driven by a simple goal: to change what’s possible for patients with kidney disease. ADPKD remains one of the most challenging areas in medicine, and we believe it requires bold thinking, rigorous science, and a team committed to doing things differently.

We’re looking for individuals who bring both scientific rigor and creativity to hard problems, and who believe great work is built through respectful, direct collaboration. You communicate with honesty and transparency, adapt quickly as priorities evolve, and hold yourself—and others—to a high standard. Above all, you operate with urgency and purpose, grounded in the knowledge that patients are waiting.

Based at Bakar Labs in Berkeley, CA, we are advancing new therapies designed to make a meaningful difference for patients.

• 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.