Director, Global Trial Lead

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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 senior leader within Global Development Operations (GDO) sets the vision for successful trial execution, influences organizational strategy, and ensures alignment with business objectives, regulatory standards, and quality benchmarks. The Director GTL leads cross‑functional study teams and study vendors, collaborates with internal and external stakeholders, drives risk management, and fosters a culture of innovation and continuous improvement.

• Provides leadership and oversight for multiple, complex clinical trials and programs, ensuring the 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 accurate data records in study management systems such as Veeva (e.g., CTMS, eTMF).
• 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 forward‑looking vision that integrates therapeutic area, program, and asset perspectives, actively promoting the exchange of best practices and lessons learned to drive accelerated progress.

• Defines and communicates the strategic direction for global clinical trial execution, ensuring alignment with organizational goals and portfolio priorities.
• Offers therapeutic and operational guidance on study protocols and execution strategies.
• Provides consultation across programs/studies with a focus on risk mitigation and operational excellence.
• Monitors trends in clinical operations and advises teams on proactive responses.
• Mentors global GDO Study Team members within assigned therapeutic areas and others, supporting the development of future leaders.
• Fosters an inclusive, high‑performing team culture, promoting collaboration, accountability, and resilience.
• Champions a culture of critical thinking, innovation, and operational excellence.
• Leads by example, modeling ethical behavior, integrity, and a commitment to continuous learning.

• Drives upfront planning of study timelines and budgets in partnership with cross‑functional teams.
• Leads quarterly budget reviews, flagging anticipated variances for assigned trials and collaborating with Finance on forecasting.
• Approves and reconciles vendor invoices, accruals, and scope amendments, ensuring alignment with contractual terms, budgetary targets, and quality standards.
• Identifies and resolves issues…