Director, Global Trial Lead

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Position Summary

The Director, Global Trial Lead (GTL) is accountable for the strategic leadership and operational excellence of global clinical trials, driving delivery across all phases and therapeutic areas. This role sets the vision for successful trial execution, influences organizational strategy, and ensures alignment with business objectives, regulatory standards, and quality benchmarks. As a senior leader within Global Development Operations (GDO), the Director GTL is responsible for critical decision making, risk management, and fostering a culture of innovation and continuous improvement. Works closely with internal and external stakeholders, identifying, defining and executing meaningful and targeted process improvement initiatives, supporting strategic planning efforts. The Director, GTL leads cross-functional study teams and study vendors to ensure successful study delivery. Collaborates and develops strategic partnerships internally within GDO, across R&D, Commercial, and other stakeholders to consistently foster innovation, maximize trial execution, and drive corporate growth strategy. This role may also lead global initiatives, mentor future leaders, and represent the organization in high-stakes internal and external forums. The Director, Global Trial Lead plays a pivotal part in driving delivery of registrational and non-registrational studies, with broad impact across therapeutic areas and global teams.

Duties/Responsibilities

Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following: 

Project Management 

• Provides leadership and oversight for multiple, complex clinical trials and programs, ensuring delivery of high-quality data and regulatory compliance.

• Spearheads collaboration with internal study teams and vendors to ensure clinical trial delivery meets established timelines, budgets, and quality benchmarks. 

• Provides strategic input on study feasibility and oversees operational activities of internal and external contributors. 

• Serves as a decision maker for complex issues, Identifies and proactively manages risks, balancing trade-offs between cost, deliverables, and quality, and timelines to achieve optimal outcomes.

• Manages the highest value study level budgets, contracts, and scope of work (SOW) for CROs and Vendor Partners.

• Participates in vendor selection and evaluation processes. Oversees vendor and partner relationships at a strategic level, ensuring alignment with contractual terms and organizational standards.

• Sets and monitors performance metrics, proactively identifying and resolving operational challenges. Utilizes quality indicators to monitor and optimize trial execution. 

• Maintains and ensures accurate data records in study management systems such as Veeva (i.e. CTMS, eTMF, etc.) 

• Establishes and maintains study-level project management tools, including action logs, decision trackers, issue registers, and risk mitigation plans. 

• Develops and enforces trial-specific standards aligned with broader portfolio strategies to promote operational consistency. 

• Leads organizational change initiatives, drives development and execution of cross-functional and global best practices.

• Fosters robust cross-functional collaboration to ensure timely and effective sharing of knowledge and information.

• Champions breakthrough innovation, consistently seeking transformative solutions that surpass conventional approaches, always aiming for greater acceleration.

• Inspires a for