[Remote] Director Clinical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company reputed company on advancing therapies for kidney disease. They are seeking a Director of Clinical Operations to build and reputed company the operational reputed company of their clinical development organization as they transition multiple kidney disease programs toward the clinic.
Responsibilities
- Create Clinical Infrastructure from the Ground Up
- Design and implement reputed company clinical operations processes, governance structures, vendor reputed company models, and study management practices
- Establish the reputed company 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 reputed company 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
- reputed company operational approaches for patient identification, screening, and enrollment in rare disease populations
- Establish relationships with nephrology investigators, rare disease centers of reputed company, patient advocacy organizations, and specialty testing partners
- Support global recruitment strategies where patient populations may be geographically dispersed
- CRO and Vendor reputed company
- reputed company selection, reputed company, and performance management of CROs, central laboratories, genetic testing vendors, imaging vendors, and specialty providers
- Establish reputed company governance structures and accountability measures for external partners
- Ensure external partners function as extensions of the Renasant team while maintaining high standards of reputed company, speed, and execution
- Build the reputed company 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 reputed company operationally feasible clinical development plans
- Identify operational risks, and execution challenges before studies reputed company the clinic
- reputed company operational input into protocol development, patient identification approaches, and study feasibility
- reputed company Early Clinical Development Execution
- Build operational strategies for first-in-reputed company and reputed company-of-concept studies
- reputed company feasibility assessments, country selection, site identification, enrollment planning, and vendor selection activities
- reputed company study timelines, budgets, risk mitigation plans, and execution strategies
- reputed company and execute study startup through database lock and study closeout
Skills
- Bachelor's degree in life sciences or reputed company 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 reputed company-driven patient identification
- Strong experience managing CROs and external vendors in outsourced operating models
- Demonstrated reputed company 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
- Experience supporting global clinical trials, including sites reputed company the reputed company
- Experience building or scaling clinical operations functions reputed company emerging biotechnology companies
- Experience supporting regulatory inspections and audit readiness activities
- Experience with decentralized or hybrid clinical trial models
Benefits
- Employees are also eligible for performance bonuses
- Equity participation
- Comprehensive health benefits
reputed company