Director/Senior Director, Clinical Operations

5AM Ventures•Berkeley, CA

3d•$210,000 - $275,000•Onsite

About The Position

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. The successful candidate will join at a stage where programs are transitioning from discovery and translational research into IND-enabling activities and first-in-human development. They will be responsible for building operational plans from the ground up, and determining how Renasant should structure its clinical execution capabilities as the company evolves. This leader will help answer fundamental questions including: What operational capabilities should be built internally versus outsourced? Which CROs, specialty laboratories, and external vendors are best positioned to support our programs, and how should those partnerships be structured, managed, and scaled as the portfolio advances? How should global clinical execution be designed and operationally managed for rare kidney diseases and genetically defined patient populations, including oversight of CROs, sites, and regional partners? Which investigator networks, patient advocacy organizations, and clinical sites will be most critical to successful development, and how should those relationships be cultivated, coordinated, and leveraged throughout the clinical lifecycle? The ideal candidate thrives in emerging biotechnology environments, enjoys creating structure where none exists, and has experience operationalizing novel therapies from preclinical development through early clinical execution.

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.

Nice To Haves

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.