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.

The Director of Operations holds accountability for the overall performance, scalability, and compliance of Operations and plays a pivotal role in advancing cross-functional partnerships, supporting business development, and ensuring the timely and effective delivery of review outcomes to customers.

WHAT YOU'LL DO

• 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.
• Attract, 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.
• 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.

WHAT YOU'LL BRING

• 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.

PHYSICAL REQUIREMENTS

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.