Director, IRB Operations

About the role

The Director of Operations provides senior-level strategic leadership, management, and oversight of all operational functions that enable and support IRB reviews. This role serves as a key executive partner to the Vice President of Operations, driving the alignment of operational strategy with organizational objectives, setting enterprise-wide standards for operational excellence, and championing continuous improvement and innovation across the department.

Responsibilities

• Define and communicate the strategic vision and long-term direction for all functions, roles, and responsibilities within IRB Operations, ensuring alignment with organizational goals.
• Establish enterprise-level procedures, systems, and capabilities that enable effective oversight, tracking, and management of daily review workflows at scale.
• Set clear, measurable, and outcomes-oriented performance expectations for direct reports and senior staff; conduct timely and constructive performance evaluations.
• Maintain a high-performance culture grounded in collaboration, accountability, data-driven decision-making, and continuous improvement.
• Arrive at, develop, and retain top operational talent through mentorship, succession planning, and professional development initiatives.
• Lead, grow, and inspire a high-performing Operations team; establish clear goals, delegate effectively, and hold leaders accountable for results.
• Oversee the design and execution of comprehensive training and education programs for Operations, including onboarding, cross-functional development, and leadership-development pathways.
• Drive enterprise-wide process optimization and efficiency initiatives, leveraging data and technology to improve throughput, quality, and customer satisfaction.
• Identify, assess, and proactively manage operational and regulatory risks; develop and implement robust mitigation strategies.
• Ensure full compliance with all applicable regulations, accreditation standards, and industry best practices across Operations.
• Lead the development, implementation, and oversight of quality-assurance frameworks and service-excellence standards throughout Operations.
• Serve as a senior-level escalation point for complex quality, compliance, or stakeholder issues; partner across functions to drive resolution.
• Build and maintain strategic relationships with customers, support business-development initiatives, and contribute to growth objectives.
• Define organizational structure, create or update job descriptions, and set strategic goals and objectives for Operations leadership and staff.
• Lead the development, implementation, and oversight of quality-assurance frameworks and service-excellence standards throughout Operations.
• Serve as the primary Operations lead for regulatory inspections, AAHRPP site visits, and customer audits; ensure operational readiness and represent the department at the highest level.
• Collaborate with and advise executive leadership on operational strategy, resource allocation, and organizational planning.
• Perform other related duties and strategic initiatives as assigned.

Qualifications

• Fifteen or more years of progressive experience in the clinical research industry, with at least five years in a senior leadership or executive Operations role.
• Demonstrated track record of leading large-scale operational functions with measurable impact.
• Extensive prior experience in commercial IRB operations strongly preferred.
• Bachelor’s degree required; advanced degree, such as an MBA or degree in a related field, preferred.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time-management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks and delegate them when appropriate.
• Ability to function effectively in a fast-paced and, at times, stressful environment.
• Proficiency with Microsoft Office Suite or related software.

Compensation

The anticipated base salary range for this position is $130,000–$180,000 annually. Actual compensation will be determined based on the candidate’s relevant experience, skills, qualifications, and other job-related factors. This position is also eligible for Univo’s comprehensive employee benefits package.