Director, Global Trial Lead
Bristol Myers Squibb
4 hours ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
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.
Duties/Responsibilities
- 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.
- Provide strategic input on study feasibility and oversee operational activities of internal and external contributors.
- Serve as a decision maker for complex issues; proactively manage risks and balance trade-offs between cost, deliverables, quality, and timelines.
- Manage study-level budgets, contracts, and scope of work (SOW) for CROs and Vendor Partners.
- Participate in vendor selection/evaluation and oversee vendor/partner relationships at a strategic level.
- 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 project management tools (action logs, decision trackers, issue registers, risk mitigation plans).
- Develop/enforce trial-specific standards aligned with portfolio strategies; lead organizational change and cross-functional/global best practices.
- Provide study input and strategic guidance; mentor global Study Team members and build a pipeline of future leaders.
- Drive upfront planning and quarterly budget reviews; approve/reconcile invoices, accruals, and scope amendments.
- Provide lifecycle leadership from start-up to close-out; coordinate cross-functional Study Teams with clinical, regulatory, and development.
- Analyze operational metrics, identify challenges, and propose actionable solutions; build and maintain strategic internal/external partnerships.
Qualifications
- BA/BS required; advanced degree (MS, PharmD, PhD, MD, or equivalent) preferred.
- Minimum 10 years of experience in clinical operations and global project management in the pharmaceutical/healthcare industry, including multinational experience.
- Director-level experience leading global clinical trials and programs; experience leading global, multi-functional study teams.
- Strategic experience managing CROs and external partners preferred.
- Proficiency in AI tools and familiarity with technological advancements preferred.
Required/Preferred Skills (Specific Knowledge, Skills, Abilities)
- Global trial & project management: strategic planning, execution, oversight; ensures regulatory compliance, patient safety, and timely, high-quality data.
- Operational & budget oversight: end-to-end trial operations (site selection, recruitment, vendor coordination, resource planning); budget forecasting/accruals/cost optimization.
- Risk & quality management: GCP/GXP compliance; risk identification/mitigation; audit readiness.
- Stakeholder & vendor engagement: influencing senior leaders; teambuilding; escalation/diplomacy; strong relationship management across geographies.
- Clinical & regulatory expertise: knowledge of trial phases, therapeutic areas, and regulatory requirements; submission readiness.
- Systems & data management: CTMS and clinical systems; supports AI-driven tools/automation.
- Leadership & collaboration: inclusive high-performing team leadership and consensus building; mentoring.
- Critical thinking & decision making: problem-solving in complex, high-pressure environments with patient-safety and data-integrity focus.
Travel Requirement
- Up to 25%.
Compensation/Benefits (as stated)
- Compensation ranges: Cambridge Crossing $238,890 - $289,482; Madison/Giralda NJ $213,300 - $258,468; Princeton NJ $213,300 - $258,468 (plus possible incentive cash/stock based on eligibility).
- Benefits include health coverage, wellbeing support programs, and financial protection (e.g., 401(k), disability, life insurance, etc.) plus paid time off (details as listed).
Application Instructions
- Apply for the role even if your resume does not perfectly match; you may be one step away from the opportunity.
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.
Duties/Responsibilities
- 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.
- Provide strategic input on study feasibility and oversee operational activities of internal and external contributors.
- Serve as a decision maker for complex issues; proactively manage risks and balance trade-offs between cost, deliverables, quality, and timelines.
- Manage study-level budgets, contracts, and scope of work (SOW) for CROs and Vendor Partners.
- Participate in vendor selection/evaluation and oversee vendor/partner relationships at a strategic level.
- 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 project management tools (action logs, decision trackers, issue registers, risk mitigation plans).
- Develop/enforce trial-specific standards aligned with portfolio strategies; lead organizational change and cross-functional/global best practices.
- Provide study input and strategic guidance; mentor global Study Team members and build a pipeline of future leaders.
- Drive upfront planning and quarterly budget reviews; approve/reconcile invoices, accruals, and scope amendments.
- Provide lifecycle leadership from start-up to close-out; coordinate cross-functional Study Teams with clinical, regulatory, and development.
- Analyze operational metrics, identify challenges, and propose actionable solutions; build and maintain strategic internal/external partnerships.
Qualifications
- BA/BS required; advanced degree (MS, PharmD, PhD, MD, or equivalent) preferred.
- Minimum 10 years of experience in clinical operations and global project management in the pharmaceutical/healthcare industry, including multinational experience.
- Director-level experience leading global clinical trials and programs; experience leading global, multi-functional study teams.
- Strategic experience managing CROs and external partners preferred.
- Proficiency in AI tools and familiarity with technological advancements preferred.
Required/Preferred Skills (Specific Knowledge, Skills, Abilities)
- Global trial & project management: strategic planning, execution, oversight; ensures regulatory compliance, patient safety, and timely, high-quality data.
- Operational & budget oversight: end-to-end trial operations (site selection, recruitment, vendor coordination, resource planning); budget forecasting/accruals/cost optimization.
- Risk & quality management: GCP/GXP compliance; risk identification/mitigation; audit readiness.
- Stakeholder & vendor engagement: influencing senior leaders; teambuilding; escalation/diplomacy; strong relationship management across geographies.
- Clinical & regulatory expertise: knowledge of trial phases, therapeutic areas, and regulatory requirements; submission readiness.
- Systems & data management: CTMS and clinical systems; supports AI-driven tools/automation.
- Leadership & collaboration: inclusive high-performing team leadership and consensus building; mentoring.
- Critical thinking & decision making: problem-solving in complex, high-pressure environments with patient-safety and data-integrity focus.
Travel Requirement
- Up to 25%.
Compensation/Benefits (as stated)
- Compensation ranges: Cambridge Crossing $238,890 - $289,482; Madison/Giralda NJ $213,300 - $258,468; Princeton NJ $213,300 - $258,468 (plus possible incentive cash/stock based on eligibility).
- Benefits include health coverage, wellbeing support programs, and financial protection (e.g., 401(k), disability, life insurance, etc.) plus paid time off (details as listed).
Application Instructions
- Apply for the role even if your resume does not perfectly match; you may be one step away from the opportunity.