Executive Director, Integrated Trial Process, PRS

Role Summary

Executive Director, Integrated Trial Process, PRS. Onsite in East Hanover, New Jersey.

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 compelling vision for integrated trial processes and the Clinical Trial Quality System (CTQS), ensuring efficiency, quality, and compliance across the end-to-end lifecycle. This includes driving clarity and simplicity, holistic process management, effective audit/inspection readiness, and the use of KPIs and metrics to monitor and sustain process health.
• Foster strong collaboration with Global Line Functions, matrix teams' leaders and senior management to drive cross-functional process integration, alignment on strategy, and share ownership of outcomes.
• Prioritize and lead process transformation initiatives that maximize business impact, focusing on simplification, automation, and innovative approaches.
• Capture and communicate business value of operational efficiencies through measurable outcomes and data-driven insights.
• Promote and apply structured process improvement methodologies (e.g., kaizen, workshops, lean approaches) 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

• Bachelor‚Äôs degree with an emphasis in quantitative science or business and 10+ years of relevant experience.
• Deep knowledge of drug development and end-to-end clinical trial processes, with expertise in clinical systems, regulatory requirements, and business change management.
• Proven ability to assess and respond to internal and external changes impacting trial processes, supporting systems, and training requirements.
• 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.
• Successful track record in clinical development, with strong Clinical Operations experience highly desirable.
• Strategic thinker with a focus on innovation, long-term planning, and process optimization to drive efficiency, compliance, and quality.
• Experience simplifying and standardizing processes, including authoring and managing quality documentation.
• Strong record of cross-functional leadership and collaboration across multiple functions within the clinical development value chain.
• Established people leader with experience in building, mentoring, and developing high-performing teams, fostering collaboration, accountability, and career growth.

Education

• Master‚Äôs Degree or higher (preferred).