Director, Global Trial Lead

Bristol Myers Squibb-posted 10 days ago
Full-time • Director
Princeton, NJ
5,001-10,000 employees
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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 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.

  • 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 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.
  • Study Input & Strategic Guidance 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, as applicable.
  • Supports building a pipeline of future leaders within Global Trial Management.
  • 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.
  • Budgeting & Resource Planning 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 impacting budget and timeline adherence.
  • Manages study/program level and vendor logistics and escalates resourcing needs appropriately.
  • Program & Study Oversight Oversees strategic planning and execution of multiple clinical trials, ensuring timely and high-quality deliverables. This may include program/study oversight for multiple clinical trials.
  • Provides lifecycle leadership and oversight from start-up to close-out phases.
  • Leads cross-functional Study Teams and coordinates with clinical, regulatory and development departments.
  • Analyzes operational metrics to optimize study execution and ensure alignment with franchise objectives.
  • Identifies organizational and procedural challenges, proposing actionable solutions.
  • Builds and maintains strategic partnerships with internal stakeholders (e.g., Clinical Research, Affiliates) and external collaborators (e.g., CROs, AROs).
  • Advanced degree (MS, PharmD, PhD, MD, or equivalent) preferred; BA/BS required.
  • Minimum 10 years of experience in clinical operations and global project management roles in the pharmaceutical or healthcare industry, including multi-national experience.
  • Experience in leading global clinical trials and programs at the Director level demonstrating strong knowledge of the study and program strategy.
  • Experience leading global and multi-functional study teams.
  • Experience in managing CROs and external partners at a strategic level preferred.
  • Proficiency in AI tools and familiarity with technological advancements preferred.
  • Global Trial & Project Management: Extensive experience in global clinical trial and project management, including strategic planning, execution, and oversight. Leads global clinical trials with expertise in planning, execution, and oversight. Ensures regulatory compliance, patient safety, and timely delivery of high-quality data. Drives project outcomes through strategic coordination and progress tracking.
  • Operational & Budget Oversight: Manages end-to-end trial operations, including site selection, recruitment, vendor coordination, and resource planning. Oversees budgets, forecasts, accruals, and cost optimization to ensure financial accuracy and efficiency.
  • Risk & Quality Management: Advanced leadership competencies with identification and mitigation of risks to ensure trial continuity and overall delivery focusing on successful analysis for the trial. Maintains GCP/GXP compliance and supports audit readiness with a strong quality mindset.
  • Stakeholder & Vendor Engagement Advanced leadership competencies and influencing skills with senior leaders and cross-functional leaders. Proven teambuilding skills and the ability to lead partnerships across projects and multidisciplinary teams. Demonstrates diplomacy and/or acts as primary point of escalation when interfacing with other functional areas, clinical research organizations (CROs) and other outside vendors. Builds strong relationships with internal and external stakeholders. Manages communications, escalations, and alignment across functions and geographies.
  • Clinical & Regulatory Expertise Demonstrates deep knowledge of clinical trial phases, therapeutic areas, and regulatory requirements. Ensures readiness for submissions and compliance with global standards.
  • Systems & Data Management Utilizes CTMS and other clinical systems to track milestones, ensure data quality, and support decision-making. Partners with technical teams to maintain system integrity. Supports AI-driven tools, technology advancement, automation and accelerating progress.
  • Leadership & Collaboration Demonstrated advanced ability to lead large cross-functional teams. Drives global teams toward shared goals. Builds consensus and fosters an inclusive, high-performing culture. Supports mentoring the new GTL team members and development of others within the department and/or enterprise.
  • Critical Thinking & Decision Making Exceptional critical thinking and problem-solving skills. Proven track record of effective decision making in complex, high-pressure environments. Solves complex problems and makes timely, informed decisions that prioritize patient safety and data integrity. Consistently makes operational decisions in a timely manner with accountability for issues follow through where issues are escalated. Uses expert judgment to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities. Acts decisively to address team challenges with a high degree of autonomy.
  • Accountability & Results Focus Owns outcomes, ensures quality, and delivers on time and within budget through proactive oversight.
  • Adaptability & Resilience Responds effectively to change and manages conflict constructively while maintaining team morale.
  • Communication & Relationship Building Has strong oral and written communication skills to influence, inform, and guide large cross-functional teams. Communicates clearly across global teams and builds strong, trust-based relationships with diverse stakeholders. Strong negotiation and relationship-building abilities. Commitment to team engagement, and organizational growth.
  • Travel requirement: up to 25%
  • We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
  • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
  • Other perks like tuition reimbursement and a recognition program.
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