Director, GCO Clinical Program Lead (GCPL)

Accountabilities:

• • 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.

  Requirements:

  • 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%.

  Benefits:

  • 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.