Executive Director, Integrated Trial Process, PRS

Role Summary

Executive Director, Integrated Trial Process, PRS is responsible for ensuring efficiency, quality, and compliance across the end-to-end clinical trial process, and serves as the Quality System Owner for the Clinical Trial Quality System (CTQS). This role builds and leads a global team of process owners and managers to strengthen process execution and accelerate trial delivery. Location: East Hanover, New Jersey (onsite).

Responsibilities

• Build, lead and develop a high-performing team of global process owners and process managers, fostering a culture of collaboration, accountability, and value delivery
• Define and execute a vision for integrated trial processes and the Clinical Trial Quality System (CTQS), ensuring efficiency, quality, and compliance across the end-to-end lifecycle, including clarity and simplicity, holistic process management, audit readiness, and the use of KPIs to monitor process health
• Foster strong collaboration with Global Line Functions, matrix team leaders, and senior management to drive cross-functional process integration and shared ownership of outcomes
• Prioritize and lead process transformation initiatives that maximize business impact, focusing on simplification, automation, and innovative approaches
• Capture and communicate the business value of operational efficiencies through measurable outcomes and data-driven insights
• Promote and apply structured process improvement methodologies (e.g., kaizen, workshops, lean) with active cross-functional participation
• Act as a change leader, enabling mindset and behavior shifts that embed efficiency, quality, and continuous improvement across research and development
• Engage and influence a broad network of senior leaders and stakeholders to ensure alignment, collaboration, and sustained adoption of integrated trial processes

Qualifications

• Required: Bachelor’s degree with an emphasis in quantitative science or business and 10+ years of relevant experience
• Required: Deep knowledge of drug development and end-to-end clinical trial processes, with expertise in clinical systems, regulatory requirements, and business change management
• Required: Proven ability to assess and respond to internal and external changes impacting trial processes, supporting systems, and training requirements
• Required: Exposure to digital transformation and innovative technologies, including leveraging automation, data, and AI-enabled solutions to enhance process efficiency and decision-making; demonstrated experience in defining and applying metrics to monitor process health, efficiency, and continuous improvement
• Required: Successful track record in clinical development, with strong Clinical Operations experience highly desirable
• Required: Strategic thinker with a focus on innovation, long-term planning, and process optimization to drive efficiency, compliance, and quality
• Required: Experience simplifying and standardizing processes, including authoring and managing quality documentation
• Required: Strong record of cross-functional leadership and collaboration across multiple functions within the clinical development value chain
• Required: Established people leader with experience in building, mentoring, and developing high-performing teams, fostering collaboration, accountability, and career growth
• Preferred: Master’s Degree or higher

Education

• Bachelor’s degree in quantitative science or business (required)
• Master’s Degree or higher (preferred)

Skills

• Cross-functional leadership and collaboration across the clinical development value chain
• Change leadership and continuous improvement across research and development
• Process transformation, simplification, automation, and innovative approaches
• Data-driven decision making with KPIs and metrics
• Knowledge of quality systems and quality documentation (e.g., CTQS)
• Digital transformation, including automation, data, and AI-enabled solutions
• Audit/inspection readiness and regulatory awareness