Director/Senior Director, Clinical Operations

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 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.

Lead Early Clinical Development Execution

• 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.

Required Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.

• 10+ years of clinical operations experience (15+ for Senior Director)

• Experience leading clinical studies from startup through database lock and study closeout.

• Experience in rare disease, nephrology, ADPKD, genetic disease, or other specialized patient populations.

• Experience with clinical studies requiring genetic testing, genetic confirmation of diagnosis, or genomics-driven patient identification.

• Strong experience managing CROs and external vendors in outsourced operating models.

• Demonstrated success leading study startup activities and global site activation efforts.

• Experience developing study budgets, timelines, and operational risk management plans.

• Strong knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.

• Excellent communication, leadership, and cross-functional collaboration skills.

Preferred Qualifications

• Experience supporting global clinical trials, including sites outside the United States.

• Experience building or scaling clinical operations functions within emerging biotechnology companies.

• Experience supporting regulatory inspections and audit readiness activities.

• Experience with decentralized or hybrid clinical trial models.