Position: Associate Director, Clinical Operations Location: South San Francisco - This position is HYBRID - Local to South San Francisco is REQUIRED Reports to: Director Clinical Operations About the Role: We are seeking an experienced clinical operations leader to oversee the execution of mid-to-late-stage clinical trials in chronic kidney disease. This individual will play a pivotal role in driving operational strategy, ensuring excellence in study execution, and influencing cross-functional program decisions. This is a confidential opportunity for an operations leader who can balance strategic vision with hands-on execution , driving collaboration across teams, vendors, and investigators while maintaining the highest standards of compliance and quality. Key Responsibilities: Clinical Trial Execution & Leadership Lead or co-lead one or more global mid-to-late-stage clinical trials, ensuring alignment with development objectives from protocol development through final CSR. Drive study feasibility and enrolment strategy, including forecasting and site selection planning. Partner with Clinical Science and KOLs to plan and execute advisory boards and committee meetings. Participate in Program Core Teams, and as needed, co-lead Clinical Development Sub-Teams (CDST). Vendor, CRO & Site Management Lead vendor/CRO RFPs, selection, contract negotiations, and ongoing performance oversight. Manage CROs, vendors, and sites to deliver on study milestones while ensuring strategic alignment. Budget & Financial Oversight Provide financial oversight across multiple studies, ensuring efficiency and alignment with corporate objectives. Lead study budget planning, forecasting, and variance management. Data Quality, Compliance & Regulatory Readiness Ensure adherence to protocols, SOPs, ICH GCP guidelines, and regulatory requirements. Partner with QA on inspection readiness, audits, and compliance initiatives. Process Optimization & Technology Identify, assess, and integrate innovative technologies (e.g., AI/ML, advanced analytics) to optimize trial execution. Collaborate with Clinical Operations on evaluation and implementation of systems (e.g., eTMF, CTMS, RBM). Contribute to best practices and process scalability across clinical operations. Cross-functional Collaboration Collaborate with clinical development, regulatory, data science, CMC, and supply chain to ensure program success. Provide clinical operations expertise to influence product-level strategy. Leadership Competencies Communication & Influence : Promotes transparency, fosters healthy debate, and ensures stakeholder alignment. Teamwork & Collaboration : Creates opportunities for cross-team connection, manages conflict effectively, and values contributions. Execution & Results : Exercises sound judgment, supports process compliance, and drives milestone achievement. Develop Others & Self : Mentors team members, models what good looks like, and invests in continuous improvement. Qualifications Bachelors degree in a scientific/health discipline; advanced degree preferred. 810 years of clinical operations experience, with leadership of Phase IIII trials and program-level strategic exposure. Experience in common and/or rare disease drug development. Strong working knowledge of FDA, EMA, ICH-GCP regulations; inspection readiness experience preferred. Proven expertise with clinical trial databases (e.g., Medidata RAVE, Veeva) and budgeting. Track record of vendor/CRO oversight, budget negotiations, and leveraging technology to improve trial efficiency. Demonstrated strategic thinking and ability to influence across program and portfolio levels. Startup/biotech mindset: adaptable, collaborative, and willing to roll up sleeves. People management experience (23 direct reports) highly desirable. Strong communication and stakeholder management skills. Willingness to travel up to 30%. Confidentiality Notice This position is for a confidential search. Candidates will receive further details regarding company information and program scope during the interview process. Reach out now: tbacchus@barringtonjames.com