Director Clinical Operations

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.

Major Responsibilities

• 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
• 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.

Qualifications

• 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.

Pay

$210,000 - $275,000 per year
Director: $210,000 - $240,000
Senior Director: $240,000 - $275,000

Schedule

Remote, United States