Executive Director, Clinical Business Operations

ESSENTIAL JOB FUNCTIONS:

The Executive Director, Clinical Business Operations serves as a strategic leader responsible for driving operational strategy, organizational effectiveness, portfolio governance, and business performance across the Clinical Operations organization. This role acts as a key advisor and thought partner to executive leadership while ensuring the organization possesses the processes, capabilities, insights, and governance necessary to successfully deliver the clinical portfolio.

The Executive Director leads enterprise-level business operations initiatives spanning Clinical Operations, Clinical Data Sciences, Clinical Systems, Biosample Operations, and other cross functional partners. This individual is responsible for establishing scalable operating models, enhancing organizational performance, enabling data-driven decision making, and driving execution of strategicpriorities.

Clinical Operations Leads remain accountable for program strategy and execution while Business Operations provides department-wide planning, governance, reporting, systems, and business infrastructure.

Organizational Strategy & Leadership

• Partner with Clinical Operations leadership to develop and execute operational strategy.
• Translate corporate objectives into actionable organizational priorities and execution plans.
• Serve as a strategic advisor to senior leadership on organizational design, resource strategy, capability development, and operational effectiveness.
• Lead transformational initiatives that improve scalability, productivity, and organizational performance.
• Develop and maintain the Clinical Business Operations roadmap, aligning organizational priorities, capabilities, and operational initiatives with the strategic direction of Clinical Operations.

Portfolio Governance & Executive Reporting

• Establish and oversee governance frameworks supporting clinical operations portfolio execution.
• Lead executive portfolio reviews and performance management processes.
• Develop and deliver executive-level business insights, performance metrics, and strategic analyses.
• Ensure visibility of portfolio risks, resource constraints, and execution challenges to leadership.

Business Performance & Operational Excellence

• Define enterprise-level KPIs and performance measurement frameworks.
• Drive a culture of accountability through transparent performance reporting and operational reviews.
• Lead continuous improvement efforts focused on operational efficiency, quality, and execution excellence.
• Benchmark organizational performance against industry best practices.
• Standardize planning methodologies, governance processes, reporting, and operational business practices across Clinical Operations to improve consistency and scalability.

Resource Strategy & Organizational Planning

• Oversee organizational capacity planning and workforce strategy.
• Partner with Clinical Operations Leads & Finance to support budget development, investment prioritization, and long-range planning.
• Evaluate organizational capabilities and identify future talent, process, and technology needs.

Cross-Functional Leadership

• Lead highly visible Clinical Operations initiatives requiring collaboration across Clinical Development, Quality Assurance, and other corporate functions.
• Build alignment among senior leaders around priorities and operational decisions.
• Drive organizational change management initiatives and foster adoption of new ways of working.

Team Leadership

• Build, lead, and develop a high-performing Clinical Business Operations organization, including executive oversight of the clinical trial associate team.
• Coach and mentor leaders and staff across the function.
• Create an environment that promotes innovation, accountability, collaboration, and continuous improvement.
• Complete other duties as assigned by the manager.

JOB SPECIFICATIONS:

• Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
• A minimum of 15+ years of biotechnology, pharmaceutical, CRO, or healthcare industry experience
• Significant leadership experience within Clinical Operations, Clinical Development, Business Operations, Program Management, or related disciplines.
• Experience leading Clinical Operations Business Operations, Portfolio Management, PMO, Operational Strategy, or related organizational functions preferred.
• Demonstrated experience developing organizational planning processes, governance frameworks, executive reporting, and business performance metrics.
• Proven ability to influence executive stakeholders and drive organizational change.
• Proven ability to build strong relationships with external partners, CROs, and vendors.
• Advanced financial, resource planning, and business management acumen.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Outstanding communication, presentation, and executive presence.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Drives and influences high-impact, cross-functional decision-making at the portfolio level, shaping strategy and aligning senior stakeholders to achieve business objectives.
• Leads cross-functional decision-making by proactively shaping and aligning stakeholders across functions, influencing program strategy and key development milestones.
• Ability to balance strategic vision with operational execution.
• In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Flexibility to travel domestically and internationally as required.