Director/Senior Director, Clinical Operations

Company Overview: 

 

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.

 

The Role: 

Renasant Bio is seeking a Director or Senior Director, Clinical Operations to build and lead the operational foundation of our clinical development organization as we advance multiple kidney disease programs toward the clinic.

 

The successful candidate will join at a stage where programs are transitioning from discovery and translational research into IND-enabling activities and first-in-human development. They will be responsible for building operational plans from the ground up, and determining how Renasant should structure its clinical execution capabilities as the company evolves.

 

This leader will help answer fundamental questions including:

• What operational capabilities should be built internally versus outsourced?

• Which CROs, specialty laboratories, and external vendors are best positioned to support our programs, and how should those partnerships be structured, managed, and scaled as the portfolio advances?

• How should global clinical execution be designed and operationally managed for rare kidney diseases and genetically defined patient populations, including oversight of CROs, sites, and regional partners?

• Which investigator networks, patient advocacy organizations, and clinical sites will be most critical to successful development, and how should those relationships be cultivated, coordinated, and leveraged throughout the clinical lifecycle?

 

The ideal candidate thrives in emerging biotechnology environments, enjoys creating structure where none exists, and has experience operationalizing novel therapies from preclinical development through early clinical execution.

Create Clinical Infrastructure from the Ground Up

• 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.

Drive Rare Disease and Genetic Testing Strategies

• 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.

CRO and Vendor Strategy

• 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.

Build the Bridge from Preclinical to Clinical

• Serve as the primary Clinical Operations leader responsible for transitioning programs from preclinical an