Senior Director Clinical Operations
Sonoma County, CAFull-timePosted Apr 22, 2026
Behavioral Health Market Context
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Qualifications
- •Must have experience within Ophthalmology
- •12–15+ years of clinical operations experience within biotech, pharma, or CRO environments
- •Proven leadership experience managing teams and complex global clinical programs
- •Deep understanding of regulatory requirements and clinical trial processes
- •Demonstrated success in vendor and CRO management
- •2 more items(s)
Responsibilities
- •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
- •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
- •19 more items(s)