5amventures - 5AM Ventures - Director/Senior Director, Clinical Operations
Requirements
• 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. • 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.
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 • 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.
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