Director, Global Trial Lead

Overview

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. This role outlines the strategic leadership and operational excellence for global clinical trials, driving delivery across all phases and therapeutic areas. The Director, Global Trial Lead (GTL) sets the vision for successful trial execution, aligns with regulatory standards and quality benchmarks, and partners with internal and external stakeholders to foster innovation and continuous improvement.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer benefits and programs to support employees in pursuing goals at work and in personal life. Read more at:

Responsibilities involve a combination of execution and oversight to ensure deliverables, potentially including the following:

• Project Management
  • Provide leadership and oversight for multiple, complex clinical trials and programs, ensuring delivery of high-quality data and regulatory compliance.
  • Collaborate with internal study teams and vendors to meet timelines, budgets, and quality benchmarks.
  • Offer strategic input on study feasibility and oversee operational activities of contributors.
  • Act as a decision maker for complex issues, identify and manage risks, and balance cost, deliverables, quality, and timelines.
  • Manage high-value study-level budgets, contracts, and SOWs for CROs and vendor partners.
  • Participate in vendor selection and evaluation; oversee relationships at a strategic level in line with contractual terms.
  • Set and monitor performance metrics; use quality indicators to optimize trial execution.
  • Maintain accurate data records in study management systems (e.g., Veeva CTMS, eTMF).
  • Establish and maintain study-level PM tools (action logs, decision trackers, issue registers, risk plans).
  • Develop and enforce trial-specific standards aligned with broader portfolio strategies.
  • Lead organizational change and cross-functional best practices; foster knowledge sharing.
  • Promote breakthroughs and innovative solutions for accelerated progress; share best practices across teams.
• Study Input & Strategic Guidance
  • Define and communicate strategic direction for global trial execution in line with portfolio priorities.
  • Provide therapeutic and operational guidance on study protocols and execution strategies.
  • Advise across programs with focus on risk mitigation and excellence; monitor operational trends and respond proactively.
  • Mentor GDO Study Team members and support leadership development within Global Trial Management.
  • Foster an inclusive, high-performing culture and promote collaboration, accountability, and resilience.
  • Promote a culture of critical thinking, innovation, and operational excellence; model ethical behavior and integrity.
• Budgeting & Resource Planning
  • Lead upfront planning of study timelines and budgets with cross-functional teams.
  • Drive quarterly budget reviews and forecast variances; reconcile vendor invoices and SOWs in line with contracts.
  • Identify and resolve issues impacting budget and timeline adherence; manage logistics and escalations as needed.
• Program & Study Oversight
  • Oversee strategic planning and execution of multiple trials; provide lifecycle leadership from start-up to close-out.
  • Lead cross-functional Study Teams and coordinate with clinical, regulatory, and development departments.
  • Analyze operational metrics to optimize study delivery and align with franchise objectives.
  • Identify challenges and propose actionable solutions; build and maintain partnerships with internal and external stakeholders.
• Qualifications
  • Advanced degree (MS, Pharm
    
    D, PhD, MD, or equivalent) preferred; BA/BS required.
  • Minimum 10 years of experience in clinical operations and global project management in pharma or healthcare, including multi-national experience.
  • Experience leading global clinical trials and programs at Director level with strong study and program strategy knowledge.
  • Experience leading global and cross-functional study teams; experience managing CROs and external partners at a strategic level preferred.
  • Proficiency with AI tools and familiarity with technological advancements preferred.
• Other Competencies
  • Global Trial & Project Management: lead global trials with regulatory compliance, patient safety, and timely data delivery.
  • Operational & Budget Oversight: manage end-to-end trial operations, budgets, forecasts, and cost optimization.
  • Risk & Quality Management: maintain GCP/GXP compliance and audit readiness with a quality mindset.
  • Stakeholder & Vendor Engagement: build relationships, manage communications, and navigate cross-functional interfaces.
  • Clinical & Regulatory Expertise: ensure readiness for submissions and global regulatory standards.
  • Systems & Data Management: use CTMS and other systems; support AI-driven tools and automation.
• Leadership & People
  • Lead large cross-functional teams; mentor GTL members and promote development.
  • Critical…