Global Study Director Cell Therapy

About this role

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.
• Collaborate to
• 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
• Develop and
• Oversee study level performance against plans, milestones, and KPIs.
• Ensure Trial Master File completion and compliance with governance controls.
• Manage study budget through lifecycle and provide progress reports.
• Ensure studies
• Support
• Provide guidance and mentoring to less experienced colleagues.
• Lead non-drug project work and improvement projects.
• University degree or equivalent in medical or biological sciences or discipline associated with clinical research.
• Proven project management experience and training.
• At least 7 years of clinical trial experience.

Requirements

• At least 3 years of experience in global study leadership and team leadership.
• Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements.
• Thorough understanding of the cross-functional clinical trial process.
• Strong strategic and critical thinking abilities.
• Proven skills in complex problem solving and decision-making.
• Strong abilities in
• Excellent communication and interpersonal skills.
• Ability to manage multiple competing priorities.
• Experience in external provider oversight and management.
• Advanced degree,
• Project management certification.
• 5 years of experience in global study leadership and team leadership.
• Significant hematology/oncology
• Experience with project management software solutions.
• Cell therapy/CAR-T experience.
• Global