Executive Director, Clinical Business Operations

Overview

This role provides global operational strategy and governance leadership for the Clinical Business Operations (CBO) team. Responsibilities include operational excellence, financial stewardship, compliance, scalability, and digital transformation initiatives across cross-functional and cross-country stakeholders.

Responsibilities

• Drive operational excellence by aligning regional execution strategies with global governance frameworks, including clear accountability models, decision-making processes, and issue escalation mechanisms.
• Oversee investigator budgets, site contracts, site payments, and budget data hub activities to support precise budget forecasting, efficient contract execution, and timely and accurate site payments and budget data entry in databases.
• Own and monitor key operational and financial performance indicators (KPIs) across investigator budgeting, site contracting, payments, and budget data governance, including:
  • Site contract cycle time and execution timeliness
  • Budget forecast accuracy and forecast vs. actual variance
  • Site payment timeliness and reconciliation accuracy
• Provide strategic oversight of investigator fee budget planning activities to support accurate financial forecasting.
• Lead the development, review, negotiation, and timely execution of site budgets and clinical trial agreements in alignment with Fair Market value principles, study requirements, organizational standards, and study start-up timelines.
• Supervise end-to-end site payment processes and payment reconciliation to ensure financial obligations are processed accurately and in accordance with contractual terms and payment schedules.
• Oversee collection, validation, and maintenance of budget-related information within designated databases and systems to support data integrity and accuracy.
• Ensure budget, contract, payment, and supporting operational documentation remains audit ready and compliant with applicable regulatory, financial, and internal governance standards.
• Maintain oversight of Sunshine reporting obligations and global transparency requirements, ensuring appropriate processes, controls, and stakeholder alignment across regions.
• Provide strategic oversight of outsourced vendors and external business partners, including performance monitoring, service quality oversight, issue escalation, and governance.
• Partner with Corporate Finance to drive financial governance, including oversight of accruals, forecast vs. actual, and reconciliation processes.
• Oversee operational finances and team resources to ensure activities remain within approved budgets and resource allocations.
• Lead, guide, and manage performance for team members to foster accountability, collaboration, and continuous improvement.
• Support implementation of automation tools and digital solutions to improve overall productivity.

Supervisory Responsibilities

• Yes

Required Qualifications

• Bachelor’s degree or above in Life Sciences, Medical Science/Medical, Finance, Health Economics, or related fields.
• 14+ years of experience in clinical operations, or study start-up, clinical site budgets, clinical site contracts within a pharmaceutical sponsor or CRO environment.
• Strong planning and organizational skills, including the ability to lead a team in a dynamic environment with competing priorities.
• Strong executive communication skills, including the ability to present data-driven insights to senior leadership.
• Solution-driven, results-focused approach with willingness to take a hands-on approach.
• Demonstrated ability to analyze complex financial data and translate insights into actionable guidance.
• Experience working cross-functionally with Clinical Operations, Finance, Payments, and Legal stakeholders.
• Advanced proficiency in Excel and data analytics tools; experience with budget systems and contract lifecycle management platforms preferred.
• Good knowledge of ICH-GCP and pharmaceutical-related regulations and laws.

Preferred Qualifications

• 20+ years of experience preferred.

Computer Skills

• Microsoft Office applications, PowerBI (or equivalent), CTMS, Contract Lifecycle Management System, Veeva, SharePoint (or equivalent tools).

Travel

• Yes, 10%

Compensation & Benefits

• Salary Range: $271,800.00 - $351,800.00 annually
• Bonus/Incentive: Non-Commercial roles are eligible to participate in the annual bonus plan; Commercial roles are eligible to participate in an incentive compensation plan.
• Equity: All employees have the opportunity to own shares through discretionary equity awards and may voluntarily participate in the Employee Stock Purchase Plan.
• Benefits package includes:
  • Medical, Dental, Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness

Location

• Not specified in the provided description.