Director, GCO Clinical Program Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop strategic operational plans and enhance clinical operational performance for assigned programs.

• Act as a point of escalation for any study-related issues within the designated programs.

• Lead, mentor, coach, and manage global Clinical Study Managers effectively.

• Propel disease and asset strategy while ensuring execution excellence with program leaders and functional representatives.

• Assist in the onboarding process and ensure high-quality execution of projects with external partners.

• Build, develop, retain, train, and assess the performance of the global gCSM team.

• Oversee project delivery, including goals, budgets, timelines, and resource allocation.

• Represent the GCO in governance teams and provide insights into clinical operations.

• Lead or participate in activities to engage Key Opinion Leaders (KOLs).

• Assess strategic feasibility and prepare budget estimates.

• Create and maintain annual program budgets, resource forecasts, and compound-level documentation.

• Supervise study planning and execution processes.

• Conduct program review meetings and monitor approved budgets and timelines.

• Provide updates on study status, goals, operational KPIs, and quality KPIs.

• Collaborate on vendor selection and governance initiatives.

• Create or evaluate performance and development plans.

• Offer line management and mentorship to gCSMs.

• Promote scientific knowledge in clinical operations, ensure global consistency, and drive process enhancements.

• Partner with cross-functional leaders to achieve clinical development objectives.

⛳️ Requirements

• Experience or exposure in project management throughout the complete lifecycle of multi-region/country clinical trials in a dynamic global environment.

• Preferred experience in people management and program management.

• Proficiency in MS Office applications.

• Proficiency in Project Planning Applications.

• Familiarity with Clinical Trial Management Systems (CTMS).

• Comprehensive understanding of ICH/GCP Guidelines and other relevant regulatory requirements.

• Willingness to travel domestically and internationally, up to 20%.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary stock awards from BeOne Medicines Ltd.

• Access to an Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance benefits.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account options.

• Life insurance coverage.

• Paid Time Off benefits.

• Wellness programs and benefits.

• Reasonable accommodations for protected individuals.