Job Description

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

• Bachelor’s degree in a scientific/health discipline; advanced degree preferred.
• 8–10 years of clinical operations experience, with leadership of Phase I–III 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 (2–3 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

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