Executive Director, Integrated Trial Process, PRS

Band

Level 7

 

Job Description Summary

Onsite
#LI-Onsite
East Hanover, New Jersey

About the role:
We work collaboratively to integrate cross-functional expertise into streamlined, end-to-end trial processes underpinned by innovation and risk-based quality management, so Novartis can deliver high-quality medicines to patients faster. The Head of Integrated Trial Process, PRS is responsible for ensuring efficiency, quality, and compliance in the end-to-end clinical trial process, while serving as Quality System Owner (QSO) for the Clinical Trial Quality System (CTQS). By building and managing a high-performing team of global process owners and process managers, the Head of Integrated Trial Process deliver results that strengthen process execution and accelerate trial delivery.

 

Job Description

Your Key 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.
   

Video Link  https://www.youtube.com/watch?v=ggbnzRY9z8w 
 

This position will be located at East Hanover, New Jersey site and will not have the ability to be located remotely.

Role Requirements:
Essential Requirements:   

• Bachelor’s 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.

Desired Requirements: 

• Master’s Degree or higher.
   

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $225,400 and $418,600/year.  The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically.

Novartis may change the published salary range based on company and market factors. Your compens