Global Study Start-Up & Activation Leader

Jobtailor; Massachusetts; On-site; USD 180,000 - 260,000; Full time

Job summary

Biogen seeks a strategic leader to oversee global study activation from protocol finalization to site initiation. You will build a high-performing team ensuring quality, compliance, and milestone delivery while managing vendors and contracts.

You will partner with Regulatory, Legal, Finance, Quality and Medical teams to drive EU-CTR strategy, digital transformation and efficient activation frameworks across trials.

Qualifications

• Bachelor’s degree required.
• 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.

Responsibilities

• 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 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.

Skills

Study Start-Up Leadership

Project Management

Regulatory Compliance

Digital Transformation in Clinical Tr

Cross-Functional Collaboration

Education

Bachelor’s degree

Tools

Automation Technologies

Data Integration Systems

Job description

Biogen seeks a strategic leader to oversee global study activation from protocol finalization to site initiation. You will build a high-performing team ensuring quality, compliance, and milestone delivery while managing vendors and contracts.

You will partner with Regulatory, Legal, Finance, Quality and Medical teams to drive EU-CTR strategy, digital transformation and efficient activation frameworks across trials.