The role leads through a management team of Directors, Associate Directors, and Senior Managers and is accountable for country‑level execution, issue resolution, and continuous performance improvement. The CCSL field‑based is a core pillar of the role, with accountability for maintaining strong investigator and site relationships, driving site intelligence, and reinforcing Biogen’s position as a sponsor of choice through scientific and operational engagement directly tied to clinical trials.

Additionally, in the new CSO operating model, the Sr Director provides governance and oversight of the Clinical Monitoring workforce supporting European markets, including Clinical Research Associates (CRAs) and Clinical Monitoring Leads (CMLs), across both FTE and FSP delivery models. This includes ensuring consistent operational standards, quality expectations, escalation pathways, and effective collaboration between monitoring teams and country/site leadership to support country performance and site delivery.

Key Responsibilities

• Accountable for CSO country’s performance across assigned European markets, including delivery governance, risk management, and resolution of operational issues.

• Leads and develops people managers and country/site leadership to ensure consistent execution, capability development, and sustainable workloads.

• Preserves and strengthens CCSL site engagement, sponsor oversight, and site intelligence to inform site selection and portfolio decisions.

• Provides oversight of monitoring delivery (CRA/CML; FTE/FSP) and ensures structured collaboration between CCSLs, country leaders, and monitoring teams.

• Partners with CRO and FSP providers drive operational excellence, monitoring effectiveness, and site performance.

• Drives and implements CSO initiatives and operating‑model changes with global applicability, supporting standardization and continuous improvement.

• Owns budget and headcount planning for the Europe markets organization and contributes to broader CSO workforce planning.

• Partner with other CSO Leaders in EU (including EU-CTR functions) to drive quality and consistency of the team.

Leadership Scope

• Leads a management organization and CCSL/country delivery teams across European markets, with indirect oversight of monitoring resources supporting the region

Education Requirements

• University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred

Minimum Experience Requirements

• Requires 15+ years’ experience in clinical development, experience across multiple clinical operations disciplines including field-based site-facing clinical operations roles, clinical trial delivery via an outsourcing model; clinical operations project leadership experience preferred but not required;

• Significant ability for strategic planning, ability to influence.

• Ability to collaborate across many functions.

• Experienced people manager.

• Strong understanding of regulatory environment regarding GCP, clinical trial regulations and regulatory guidance pertinent to clinical trial conduct in assigned region

• Strong project management skills and experience leading internal and external global cross-functional projects.

• Strong interpersonal and communication skills, including experience working with various levels of senior management.