Director/Senior Director, Clinical Operations

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🏄 California – Remote

🏄 California – Remote

💵 $210k - $270k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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5AM Ventures

WebsiteLinkedInAll Job Openings

11 - 50 employees

5AM was founded in 2002 and pursues investments in advanced life science innovations, and seeks to be diversified across the biopharmaceutical therapeutics, and platform technologies. Within each sector, 5AM invests across multiple therapeutic areas and modalities and evaluates opportunities based on innovative platform technologies, corporate spin-offs and products with shorter development cycles.

📋 Description

• 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. • 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. • 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. • 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. • 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.

🎯 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.

🏖️ Benefits

• Employees are also eligible for performance bonuses • equity participation • comprehensive health benefits