Job Description

Summary

The Director of Clinical Operations leads operations across all current and future clinical sites to ensure operational and financial objectives are met. This role is directly accountable for achieving enrollment goals, compliance standards, clinical trial milestones, study and site budgets, profitability, revenue targets, and staff retention. Additional responsibilities include ensuring clinical quality of care, patient satisfaction, client satisfaction, productivity, and staff leadership. This individual will maintain a strong presence across sites, supporting directors, solving problems in real time, and driving performance. The ideal candidate brings a deep understanding of site operations, financial analytics, and organizational leadership, with a proven track record of growing clinical sites and optimizing team performance.

Duties and Responsibilities

Strategic & Financial Planning

• Contribute to the development and implementation of the company’s long-range operational strategy.
• Develop and execute departmental and site goals, ensuring alignment with overall business objectives.
• Monitor key performance indicators (revenue, profit, and operational metrics), investigate variances, and recommend adjustments.
• Prepare annual operating and capital budgets in a timely manner.
• Partner with Finance and Business Operations to establish reporting systems and controls.
• Assess needs for site expansion and restructuring, including layouts and construction planning.
• Collaborate with business development and patient recruitment teams to drive growth and market expansion.

Clinical Expertise

• Provide oversight of Clinical Operations leaders and other functional teams involved in trial execution.
• Foster a culture of quality and compliance, ensuring adherence to ICH/GCP, SOPs, policies, and industry best practices.
• Offer operational and clinical expertise in support of clinical development program design and execution.
• Lead risk management efforts, proactively resolving and escalating study issues as needed.
• Implement initiatives to strengthen infrastructure, streamline processes, and enhance operational efficiency.
• Support SOP development and ensure readiness for regulatory inspections.

People Leadership

• Translate company strategy into actionable goals for team performance and growth.
• Oversee employee productivity and foster a culture of mentorship, inclusion, and professional development.
• Develop and implement KPIs, bonus structures, and performance metrics.
• Collaborate with leadership and HR on personnel issues while maintaining a positive and productive workplace.

Key Performance Indicators

Financial & Business Performance

• Monthly revenue vs. forecast (per site and overall)
• Study profitability and cost per visit tracking
• Study startup timelines and budget finalization metrics
• Operational gaps tied to protocol deviations

Site Operations & Capacity

• Active studies per site vs. staffing capacity
• Staff utilization rates
• Feasibility to first patient in timelines
• Monitor visit completion rates
• Protocol adherence

People & Team Accountability

• Quarterly KPI review completion
• Performance improvement plan execution
• Cross-department collaboration scores
• Frequency of site visits by leadership

Growth & Expansion

• New site launches or expanded capabilities
• Feasibility response and win rate
• Vendor/system implementation and adoption

Qualifications

• Bachelor’s degree in science/healthcare (or nursing/psychiatry/psychology); advanced degree preferred.
• 10+ years of clinical operations experience in a sponsor, CRO, or site setting, with at least 5 years of people management.
• Must have prior Clinical Research Coordinating experience
• Strong coaching and mentoring abilities.
• Experience in psychiatry and/or women’s health is a plus.
• In-depth knowledge of GCP, ICH, and FDA regulations.
• Proven financial and budget management skills.
• Excellent leadership, interpersonal, and communication skills.
• Strong organizational skills with attention to detail and the ability to manage multiple priorities.
• Willingness to travel regularly to clinical sites and occasionally out of state.

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