Global Study Start-up Lead

Biopharma Careers; Warszawa; Hybrid; PLN 220,000 - 350,000; Full time

Job summary

Astellas is seeking a Study Start-up Lead in Warsaw, Poland, to manage global start-up activities with a team of professionals. The role combines leadership, process improvement, and cross-functional collaboration across clinical operations.

Applicants should have a BA/BS and extensive experience in global drug development, with a focus on study start-up, regulatory compliance, and leadership. The position requires English and local language fluency and ~30% travel.

Qualifications

• BA/BS degree required.
• Extensive experience in global drug development programs and trials.
• Proven track record in study start-up activities with people management.
• Strong leadership and communication skills, able to collaborate cross-functionally.
• Extensive knowledge of ICH/GCP guidelines and multinational trial regulations.
• Experience across multiple development phases and therapeutic areas.
• Proven ability to drive global process or system improvements.
• Strong knowledge of clinical development processes and global programs.
• Excellent written and verbal communication skills in English and local language.
• Travel around 30% expected.

Responsibilities

• Resource planning, recruitment, mentoring and retention of study start-up staff.
• Manage study start-up resources for trials and oversee up to 12 direct reports.
• Provide leadership and development opportunities for staff.
• Ensure timely, high-quality start-up activities per agreed timelines and standards.
• Oversee compliance with training, documentation and regulatory requirements.
• Collaborate with Portfolio Operations Leads and Clinical Operations Leads to align standards.
• Identify and drive process improvements for study start-up activities.
• Support development and implementation of best-in-class study start-up standards.

Skills

Drug development

Study start-up

People management

Leadership

ICH/GCP knowledge

Cross-functional collaboration

Education

BA/BS degree

Job description

Astellas is seeking a Study Start-up Lead in Warsaw, Poland, to manage global start-up activities with a team of professionals. The role combines leadership, process improvement, and cross-functional collaboration across clinical operations.

Applicants should have a BA/BS and extensive experience in global drug development, with a focus on study start-up, regulatory compliance, and leadership. The position requires English and local language fluency and ~30% travel.