Global Study Director (GSD)

Role Summary

Introduction to role: Are you ready to lead the charge in groundbreaking clinical studies? As a Global Study Director (GSD), you will play a pivotal role in the Cell Therapy Clinical Operations organization, driving the operational planning and delivery of high-priority and complex clinical studies. Your expertise will ensure the successful execution of clinical trials, managing quality, timelines, budgets, resources, investigational sites, vendors, and key project deliverables. Leading a cross-functional study team, you will provide direction and guidance to achieve study milestones. Collaborate with internal and external stakeholders to resolve issues and ensure compliance with SOPs, regulatory requirements, and ICH/GCP guidelines. Your leadership will extend to mentoring GSADs and spearheading non-drug programs and improvement projects.

Responsibilities

• Lead and coordinate a cross-functional study team to ensure clinical study progress according to timelines, budget, and quality standards.
• Contribute to vendor/ESP selection activities and lead operational oversight at the study level.
• Assist with operational planning for upcoming clinical studies, interfacing with cross-functional partners.
• Collaborate to establish strategies for increasing efficiency of global study teams.
• Facilitate communication across functions and provide guidance to study team members.
• Serve as the primary AZ contact for outsourced studies, ensuring delivery according to agreed standards.
• Hold accountability for essential study level documents development.
• Ensure external service providers perform to contracted goals and timelines.
• Develop and maintain relevant study plans, including risk management planning.
• Oversee study level performance against plans, milestones, and KPIs.
• Identify and report quality issues within the study and collaborate to overcome barriers.
• Ensure Trial Master File completion and compliance with governance controls.
• Manage study budget through lifecycle and provide progress reports.
• Ensure studies are inspection-ready at all times.
• Support professional development of team members.
• Provide guidance and mentoring to less experienced colleagues.
• Lead non-drug project work and improvement projects.

Qualifications

• Required: University degree or equivalent in medical or biological sciences or discipline associated with clinical research.
• Required: Proven project management experience and training.
• Required: At least 7 years of clinical trial experience.
• Required: At least 3 years of experience in global study leadership and team leadership.
• Required: Demonstrated clinical trial expertise in hematology and/or oncology.
• Required: Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements.
• Required: Thorough understanding of the cross-functional clinical trial process.
• Required: Strong strategic and critical thinking abilities.
• Required: Proven skills in complex problem solving and decision-making.
• Required: Strong abilities in establishing effective working relationships with senior stakeholders.
• Required: Demonstrated abilities in mentoring.
• Required: Excellent communication and interpersonal skills.
• Required: Ability to manage multiple competing priorities.
• Required: Experience in external provider oversight and management.
• Preferred: Advanced degree, masters level education or higher.
• Preferred: Project management certification.
• Preferred: 5 years of experience in global study leadership and team leadership.
• Preferred: Significant hematology/oncology expertise.
• Preferred: Expertise in different phases of clinical delivery.
• Preferred: Experience with project management software solutions.
• Preferred: Cell therapy/CAR-T experience.
• Preferred: Global phase 3 study experience.

Skills

• Excellent communication and interpersonal skills
• Strong strategic and critical thinking abilities
• Proven project management and oversight capabilities
• Mentoring and leadership of cross-functional teams
• Ability to manage multiple priorities and stakeholders

Education

• University degree or equivalent in medical or biological sciences or discipline associated with clinical research