Senior Director Clinical Operations (Sonoma)

Senior Director, Clinical Operations - Ophthalmology

Position Overview

We are seeking a strategic and execution-focused Senior Director of Clinical Operations to lead the planning, implementation, and oversight of global clinical trials. This individual will be responsible for driving operational excellence across multiple programs, ensuring studies are delivered on time, within budget, and in compliance with regulatory standards.

The ideal candidate brings deep therapeutic and operational expertise, strong leadership capabilities, and a track record of successfully scaling clinical programs in a fast-paced environment.

Key Responsibilities

• Lead the operational strategy and execution of Phase I–IV clinical trials across multiple indications
• Translate development plans into executable clinical strategies with clear timelines, milestones, and resource allocation
• Oversee study startup, enrollment, conduct, and closeout activities to ensure delivery against key objectives
• Identify and proactively mitigate risks to study timelines, quality, and budget
• Build, mentor, and lead a high-performing clinical operations team including Directors, Clinical Trial Managers, and CRAs
• Establish clear performance expectations, development plans, and succession pathways
• Foster a culture of accountability, collaboration, and continuous improvement
• Select, manage, and evaluate CROs and external vendors
• Ensure vendor performance aligns with study goals, timelines, and quality expectations
• Lead governance structures including regular business reviews and escalation management
• Partner closely with Clinical Development, Regulatory, Data Management, Biostatistics, and Medical Affairs
• Ensure alignment between clinical operations and broader program strategy
• Serve as a key operational voice in cross-functional leadership meetings
• Develop and manage clinical trial budgets and forecasts
• Optimize resource allocation across programs and geographies
• Ensure financial discipline while maintaining study quality and timelines
• Ensure all trials are conducted in accordance with ICH-GCP, FDA, EMA, and other regulatory requirements
• Oversee inspection readiness and support regulatory audits
• Implement and maintain SOPs, processes, and systems to ensure operational excellence

Qualifications

• Must have experience within Ophthalmology
• Bachelor’s degree required; advanced degree (MS, PhD, or MBA) preferred
• 12–15+ years of clinical operations experience within biotech, pharma, or CRO environments
• Proven leadership experience managing teams and complex global clinical programs
• Strong experience overseeing Phase II and III trials; Phase I and IV experience a plus
• Deep understanding of regulatory requirements and clinical trial processes
• Demonstrated success in vendor and CRO management