Senior Director, U.S. Regional Clinical Operations

Role Overview

The Senior Director, U.S. Regional Clinical Operations is accountable for country-level clinical operational trial execution and delivery of the IND portfolio in the U.S. This position is responsible for providing strategic leadership and operational oversight for all U.S.-based clinical trial execution activities across the clinical development portfolio.

Key Responsibilities

• Regional Clinical Operations Leadership
  Lead and develop the U.S. Regional Clinical Operations organization, including monitoring, site management, site activation, and regional startup personnel.
  Establish a scalable regional operating model capable of supporting a growing pipeline of complex studies, including oncology, hematology, cell therapy, and autoimmune disease programs.
  Define organizational goals, performance metrics, and operational standards for regional clinical operations.
  Foster a culture of accountability, patient centricity, operational excellence, innovation, and continuous improvement.

• Site Startup and Activation Leadership
  Provide strategic oversight of all U.S. study startup activities including site identification, feasibility, site selection, site activation, and enrollment readiness.
  Drive acceleration of startup timelines through optimization of operational processes, vendor partnerships, and investigator engagement models.
  Partner with Regulatory Affairs, Legal, and Site Contracts teams to remove barriers to site activation.
  Establish performance metrics and cycle-time targets for startup effectiveness across the portfolio.

• Site Management and Monitoring Oversight
  Provide leadership and oversight for regional site management and monitoring activities.
  Ensure monitoring strategies are effectively implemented and aligned with risk-based quality management principles.
  Maintain oversight of site performance, protocol compliance, data quality, patient safety, and issue escalation activities.
  Ensure inspection readiness across all sites and clinical operations processes.

• Enrollment and Site Performance Optimization
  Develop and execute strategies to improve patient recruitment, enrollment productivity, retention, and site engagement.
  Implement performance management frameworks to identify enrollment risks and deploy proactive mitigation plans.
  Utilize operational analytics to monitor site performance and optimize resource allocation.
  Develop and execute a comprehensive U.S. site engagement strategy to strengthen partnerships with investigators, study coordinators, site networks, and research institutions, positioning the company as a sponsor of choice.

• Site Relationship Management
  Oversee strategic site outreach initiatives to improve site experience, reduce operational burden, gather site feedback, and drive continuous improvement across trial execution processes.
  Monitor site satisfaction and engagement metrics and implement action plans to strengthen site partnerships, improve retention of high-performing sites, and increase repeat participation across the clinical portfolio.
  Partner with Clinical Development, Clinical Trial Delivery, and Clinical Operations Capabilities teams to ensure investigator and site perspectives are incorporated into protocol design, operational planning, patient recruitment strategies, and study execution models.
  Lead development of a site relationship management framework, including strategic site segmentation, key account management approaches, communication plans, and governance processes for priority sites and networks.
  Sponsor investigator engagement forums, advisory boards, site councils, and other external interactions to enhance collaboration, identify barriers to participation, and improve overall clinical trial performance.

• Inspection Readiness and Compliance
  Ensure all studies are conducted in accordance with ICH-GCP guidelines, company SOPs, FDA regulations, and applicable local requirements.
  Maintain a state of continuous inspection readiness across all regional activities.
  Support internal audits, regulatory inspections, and CAPA management activities.
  Partner with Quality Assurance to drive compliance excellence across the organization.

• Strategic Portfolio Contribution
  Represent Regional Clinical Operations on study teams, development teams, portfolio governance forums, and leadership committees.
  Provide operational input into protocol development, country strategy discussions, enrollment planning, and risk assessments.
  Participate in clinical development planning to ensure operational feasibility and execution excellence.
  Influence future operating models, technology adoption, and organizational capabilities.

• Financial and Resource Management
  Manage departmental budgets and resource forecasts, including FTE and FSP resource requirements to enable industry leading portfolio acceleration in the U.S.
  Optimize utilization of internal resources and outsourced partners.
  Ensure effective workforce planning to support current and future portfolio demands.
  Support long-range planning and organizational scaling initiatives.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• Minimum 15+ years of progressive clinical operations experience within biotechnology, pharmaceutical, or CRO organizations.
• Minimum 8+ years of people leadership experience.
• Proven delivery of ambitious site start-up cycle times and enrollment execution timelines in the U.S.
• Significant experience leading regional clinical operations, site management, monitoring, or study startup organizations.
• Demonstrated success overseeing complex Phase I–IV global clinical trials.
• Experience in oncology, hematology, immunology, rare disease, or cell therapy strongly preferred.
• Experience supporting FDA inspections and regulatory authority interactions.
• Proven track record of building and developing high-performing clinical operations teams.
• Deep understanding of global clinical trial operations and regional execution models, specifically in the U.S.
• Expert knowledge of FDA regulations, ICH-GCP, and risk-based quality management principles.
• Strong understanding of site startup, monitoring, enrollment management, and site engagement strategies in the U.S.
• Demonstrated ability to lead large, matrixed organizations through growth and transformation.
• Strong business acumen and financial management capability.
• Data-driven decision-making and operational analytics expertise.
• Excellent executive communication and stakeholder management skills.
• Proven ability to influence cross-functional leaders and drive organizational alignment.
• Strategic thinker with strong execution focus and operational rigor.