Position: Clinical Operations Associate Director Location: South San Francisco - This position is HYBRID - Local to South San Francisco is REQUIRED Reports to: Director of Clinical Operations About the Role: We are on the lookout for an experienced clinical operations leader to take the helm in overseeing the execution of critical mid-to-late-stage clinical trials in chronic kidney disease. This key role will involve shaping operational strategies, ensuring top-notch execution of studies, and contributing to cross-functional program decisions that impact overall outcomes. This is a confidential opportunity for a results-oriented operations leader who excels in balancing strategic vision with practical execution . Your role will involve fostering collaboration among 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 enrollment strategy, including forecasting and site selection planning. Collaborate with Clinical Science and KOLs to effectively plan and execute advisory boards and committee meetings. Participate in Program Core Teams and co-lead Clinical Development Sub-Teams (CDST) as appropriate. Vendor, CRO & Site Management Oversee vendor/CRO RFPs, selection processes, contract negotiations, and ongoing performance management. Manage CROs, vendors, and sites to ensure timely achievement of study milestones while maintaining strategic alignment. Budget & Financial Oversight Provide comprehensive financial oversight across multiple studies, ensuring operational efficiency and alignment with corporate objectives. Lead budget planning, forecasting, and variance management for studies. Data Quality, Compliance & Regulatory Readiness Ensure strict adherence to protocols, SOPs, ICH GCP guidelines, and regulatory requirements. Work closely with QA on inspection readiness, audits, and compliance initiatives. Process Optimization & Technology Identify, evaluate, and integrate innovative technologies (e.g., AI/ML, advanced analytics) to enhance trial execution. Collaborate with Clinical Operations on the assessment and implementation of systems (e.g., eTMF, CTMS, RBM). Contribute to best practices and scalability of processes across clinical operations. Cross-functional Collaboration Engage with clinical development, regulatory, data science, CMC, and supply chain teams to ensure program success. Provide clinical operations expertise to shape product-level strategy effectively. Leadership Competencies Communication & Influence: Encourage transparency, foster constructive dialogue, and ensure stakeholder alignment. Teamwork & Collaboration: Create opportunities for team connections, manage conflicts effectively, and value contributions from all members. Execution & Results: Exercise sound judgment, uphold process compliance, and propel milestones to achievement. Develop Others & Self: Mentor team members, exemplify best practices, and commit to continuous improvement. Qualifications Bachelor's degree in a scientific/health discipline; advanced degree preferred. 8-10 years of clinical operations experience with proven leadership in Phase I-III trials and strategic program-level exposure. Experience in drug development for common and/or rare diseases. Strong familiarity with FDA, EMA, and ICH-GCP regulations; experience with inspection readiness is desirable. Proven ability with clinical trial databases (e.g., Medidata RAVE, Veeva) and financial budgeting. Demonstrated track record of vendor/CRO oversight, budget negotiation skills, and leveraging technology for enhanced trial efficiency. Proven strategic thinking ability and capability to influence across program and portfolio levels. Startup or biotech mindset: adaptable, collaborative, and hands-on. Experience managing people, including 2-3 direct reports, is highly desirable. Exceptional communication and stakeholder management skills. Willingness to travel up to 30% as needed. Confidentiality Notice This position is for a confidential search. Candidates will receive further details regarding company information and program scope during the interview process.