Global Study Start-up Lead

Astellas Pharma; Addlestone; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Astellas is seeking a Study Start-up Lead based in Addlestone, UK. This permanent hybrid role directs study start-up staff globally, aligns timelines and budgets, and drives scalable processes across clinical programs.

You will lead a team, mentor staff, collaborate with Clinical Operations and cross-functional partners, and ensure compliance with ICH/GCP guidelines while supporting global trials. Moderate travel (~30%) required.

Qualifications

• BA/BS degree required; advanced degree preferred.
• Experience in global drug development programs and trials.
• Strong study start-up expertise with people management.
• Leadership and cross-functional collaboration in Clinical Operations.
• Extensive knowledge of ICH/GCP guidelines and multinational regulations.
• Experience across multiple development phases and therapeutic areas.
• Proven ability to lead global process improvements and initiatives.
• Excellent written and verbal communication; fluent in English and local language.
• Travel approximately 30%.

Responsibilities

• Directly manage study start-up staff across trials.
• Allocate resources and monitor performance for up to 12 direct reports.
• Provide leadership, mentorship and development for staff.
• Ensure study start-up activities meet timelines and quality standards.
• Escalate issues and drive training as needed.
• Collaborate with Portfolio Operations and Clinical Operations to align best practices.
• Develop and implement global study start-up standards and processes.

Skills

Drug development

Study start-up

Leadership

ICH/GCP knowledge

Education

BA/BS degree

Advanced Degree

Job description

Astellas is seeking a Study Start-up Lead based in Addlestone, UK. This permanent hybrid role directs study start-up staff globally, aligns timelines and budgets, and drives scalable processes across clinical programs.

You will lead a team, mentor staff, collaborate with Clinical Operations and cross-functional partners, and ensure compliance with ICH/GCP guidelines while supporting global trials. Moderate travel (~30%) required.