Global Director of Clinical Operations

Alfasigma; Bologna; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Professional growth

Job summary

Alfasigma, headquartered in Bologna and Milan, seeks a Director, Global Clinical Operations to lead strategic and operational execution of global clinical programs across Phase I–IV, ensuring trials run on time, within budget and compliant.

You will collaborate with Clinical Development, Medical, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, and CROs, mentor a diverse team, and drive continuous improvement.

Qualifications

• Bachelor's degree in a scientific or health-related field; advanced degree preferred.
• 10+ years of experience in Clinical Operations, including at least 5 years in sponsor organizations.
• Proven leadership experience and talent development.

Responsibilities

• Provide strategic oversight and operational leadership for global clinical programs (Phase I–IV).
• Ensure trials are delivered on time, within budget, with quality and regulatory compliance.
• Lead planning, execution, monitoring, and delivery of clinical studies.
• Collaborate with Clinical Development, Medical, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance.
• Serve as Clinical Operations representative within Development and Program Teams.
• Drive feasibility assessments, planning, risk identification, and mitigation.
• Oversee CROs/vendors; ensure performance, budgeting, and issue resolution.
• Lead contract oversight and CRO governance across global programs.
• Monitor study progress via KPIs and address operational challenges.
• Ensure compliance with ICH-GCP, FDA, EMA, and global regulations.
• Provide line management, coaching, and resource planning for team members.
• Promote a culture of quality, accountability, and continuous improvement.
• Contribute to process enhancements and inspection readiness.
• Review study protocols, CTAs, reports, and critical documentation.
• Present updates to senior leadership and external stakeholders.

Skills

Leadership

Clinical Operations

CRO management

Budget & timelines

Stakeholder management

Global program management

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva

EDC

eTMF

MS Office

Job description

Alfasigma, headquartered in Bologna and Milan, seeks a Director, Global Clinical Operations to lead strategic and operational execution of global clinical programs across Phase I–IV, ensuring trials run on time, within budget and compliant.

You will collaborate with Clinical Development, Medical, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, and CROs, mentor a diverse team, and drive continuous improvement.