Monitoring Functional Excellence Director

Role Summary

The Functional Excellence Director for site monitoring leads the strategic and operational advancement of field monitoring strategic capabilities across Novartis Global Clinical Operations. This role embeds functional excellence, harmonizes monitoring practices, and drives innovation across global hubs and country teams. It supports the Monitoring Excellence Head and collaborates with the Central Monitoring Head to ensure alignment with RBQM principles and transformation goals. Location: East Hanover. Hybrid working; distant arrangement possible for US associates not within commuting distance, with related travel and home office considerations.

Responsibilities

• Define and implement excellence strategies across key monitoring roles to streamline and strengthen monitoring at Novartis.
• Embed risk-based approaches in all monitoring practices and ensure a clear connection between field monitoring activities and the IQRMP process.
• Lead capability development for field-based staff in an agile, RBQM model.
• Lead transformation programs across geographies and therapeutic areas to modernize trial monitoring.
• Champion innovation, identifying opportunities for advancements and staying ahead of industry trends.
• Serve as a strategic advisor to senior leadership on field excellence and capability gaps.
• Promote the implementation and champion of digital tools and advanced analytics to strengthen field monitoring processes.
• Partner with Compliance to identify and implement process improvements across field monitoring.

Qualifications

• Required: ≥ 8 years of recent pharmaceutical industry experience, with global strategy or clinical research experience in pharmaceutical industry, CROs, or regulatory agency.
• Required: Strong global leadership skills and ability to develop high-performing diverse teams.
• Required: Strong understanding of clinical trials and evolving regulatory expectations for trial monitoring.
• Required: Experience building new capability or significantly transforming an existing one.
• Required: Proven ability to build effective partnerships with internal and external partners.
• Required: Effective influencing, negotiation, and conflict resolution skills with enterprise mindset and ability to drive aligned solutions.

Skills

• Aptitude for data analytics and critical thinking.
• Leadership in process, technology, and ways of working with focus on sustainable, scalable solutions; digital savviness.

Education

Additional Requirements