Director, GCO Clinical Program Lead (GCPL)

Jobgether · United States

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, GCO Clinical Program Lead (GCPL) based in the United States. This is a senior global clinical operations leadership role responsible for strategic operational planning and execution across designated clinical development programs. You will guide complex, multi-region clinical trials while ensuring delivery against quality, budget, timeline, and performance objectives. The role provides strategic direction to Global Clinical Study Managers and serves as a key escalation point for study and program-level issues. You will collaborate with R&D leaders, functional partners, governance groups, vendors, and external partners to advance development strategies and execution excellence. A major focus will be supporting partnership studies through an integrated clinical development model and enabling seamless onboarding and delivery. The position offers significant influence over program strategy, talent development, process improvement, and operational standards in a fast-paced global environment. This is an international opportunity for an experienced clinical operations leader motivated by innovation, collaboration, and meaningful patient impact. \nAccountabilities:

• Provide strategic operational leadership for designated global clinical development programs, overseeing study delivery, performance, quality, timelines, budgets, and operational KPIs.
• Lead, develop, mentor, and retain Global Clinical Study Managers, including hiring, onboarding, performance management, resource planning, career development, and succession planning.
• Serve as the primary escalation point for complex study and compound-related issues, driving timely and effective resolution across cross-functional teams.
• Partner with program and franchise leadership to establish clinical operations strategies, priorities, standards, performance measures, and capability development initiatives.
• Represent Clinical Operations in governance forums and provide operational insight that informs program strategy, development decisions, and execution plans.
• Support KOL engagement activities and act as a clinical operations spokesperson when appropriate.
• Evaluate strategic feasibility and budget estimates during early planning and when study strategies change, ensuring appropriate resources and study structures are established.
• Develop and manage annual program budgets, resource forecasts, operational goals, and associated performance tracking.
• Oversee the creation, review, and maintenance of compound-level and study documentation, including investigator materials, safety reports, and protocols.
• Ensure timely, efficient, and high-quality planning and execution of clinical studies across multiple regions and countries.
• Conduct regular program reviews to assess study progress, risks, budgets, timelines, quality indicators, and development goals.
• Collaborate with compliance and functional partners to establish and maintain quality and operational KPIs.
• Support vendor selection, governance, performance management, and global vendor strategy in collaboration with other clinical operations leaders.
• Provide expert guidance on clinical trial execution, ICH/GCP requirements, and applicable regulatory standards.
• Drive continuous improvement initiatives that enhance clinical operations effectiveness, consistency, scientific knowledge, and global ways of working.
• Partner with cross-functional leaders and external collaborators to support seamless onboarding and successful execution of partnership-based clinical studies.
• Champion a global, collaborative mindset across Clinical Operations and strengthen consistency across programs and regions.

• Bachelor’s degree or higher in a scientific, healthcare, or related discipline, with 10+ years of experience in the clinical trial industry.
• Extensive experience managing the full lifecycle of multi-region or multinational clinical trials within a fast-paced global environment.
• Demonstrated experience in both clinical program management and people leadership, preferably managing global clinical study teams.
• Strong understanding of clinical development operations, including strategic planning, feasibility, budgeting, resource allocation, study execution, and operational governance.
• Deep knowledge of ICH/GCP guidelines and other applicable clinical research and regulatory requirements.
• Experience managing complex programs across multiple countries, functions, vendors, and stakeholder groups.
• Strong leadership and coaching capabilities, with a demonstrated ability to build high-performing teams and develop clinical operations talent.
• Excellent strategic thinking, analytical, organizational, and problem-solving skills, with the ability to make sound decisions in complex and changing environments.
• Strong executive communication and stakeholder-management skills, with the ability to influence cross-functional leaders and drive alignment.
• Ability to balance long-term program strategy with hands-on operational oversight and timely issue resolution.
• Experience with MS Office, project planning applications, and Clinical Trial Management Systems (CTMS).
• Demonstrated ability to foster teamwork, embrace change, promote continuous learning, and communicate with clarity.
• Strong results orientation, financial awareness, initiative, and an entrepreneurial approach to solving operational challenges.
• Willingness and ability to travel domestically and internationally, up to approximately 20%.

• Annual base salary: $171,900–$231,900, with final compensation determined by experience, qualifications, location, certifications, and other relevant factors.
• Eligibility for an annual bonus plan.
• Opportunity to receive discretionary equity awards and participate voluntarily in an Employee Stock Purchase Plan.
• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement benefits.
• FSA/HSA options.
• Life insurance coverage.
• Paid time off and wellness benefits.
• Opportunity to work in a global, highly collaborative clinical development environment.
• Significant opportunities for professional development, leadership growth, and talent development.
• Remote work environment within the United States, with international collaboration and travel.

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