Head of Clinical Trial Start Up

Lead global study activation from protocol finalization through site initiation and activation
Build and sustain a team delivering study start-up quality and compliance while meeting milestone time requirements
Evaluate and refine processes and systems to create scalable, efficient, and compliant study activation frameworks
Govern outsourced activation activities, including vendor oversight and contractual management
Align cross-functionally with Regulatory, Legal, Finance, Quality, and Medical teams
Strengthen global activation competencies and talent pipeline within Biogen
Drive integration and visibility across data and systems for transparent performance assessment and strategic opportunity identification
Provide strategic and operational leadership for study start-up, site activation, contracting, budgeting, and EU-CTR strategy
Transform activation capabilities through technology, process innovation, and automation
Manage resources, develop talent, and foster a culture of continuous improvement

• Bachelor’s degree required
• At least 12 years of experience in study start-up, clinical study/trial activation leadership
• Extensive project management skills and experience in global cross-functional delivery
• Exceptional critical thinking and problem-solving skills
• Robust understanding of clinical development processes and regulatory environment
• Strong executive presence and ability to represent functions in senior executive forums
• Experience with digital/technology transformation in clinical trials
• Strong decision-making and risk management orientation
• High emotional intelligence and resilience in ambiguous environments

Demonstrates extensive expertise in study start-up and clinical trial activation, with a strong focus on project management, regulatory compliance, and cross-functional collaboration. Proven ability to lead teams, drive process innovation, and manage resources effectively in a global context.

• Study Start-Up Leadership
• Project Management
• Regulatory Compliance
• Digital Transformation in Clinical Trials
• Cross-Functional Collaboration

• Clinical Development Processes
• Study Activation Frameworks
• Contractual Management
• Budgeting
• Risk Management

• Critical Thinking
• Problem-Solving
• Emotional Intelligence
• Resilience
• Executive Presence

• Clinical Trials
• Global Study Activation
• Vendor Oversight
• Continuous Improvement
• Talent Development

• Automation Technologies
• Data Integration Systems