Director, Country & Site Operations (CSO), Europe

Biogen; Baar; Vor Ort; CHF 220.000 - 320.000; Vollzeit

Zusammenfassung

Biogen in Europe seeks a Director, Country & Site Operations (CSO) to lead country and site execution across assigned European markets, supporting Biogen clinical trials across all phases and therapeutic areas. The role reports to regional executives and guides CCSLs, site engagement, sponsor oversight, and operational risk management.

You will build cross‑functional partnerships with Worldwide Medical, CTDU, QA, CRO partners, and affiliate leadership; oversee 5–8 direct reports and 15–25

Qualifikationen

• 12+ years of experience in clinical development or clinical operations.
• Experience leading clinical operations activities across multiple countries or sub-regional clusters.
• Experience working with global study teams, affiliate organizations, Medical, Development, Quality, monitoring teams, CRO/FSP partners, and external stakeholders.
• Demonstrated experience managing people and/or matrix teams and delivering operational results.
• Deep knowledge of global clinical development and trial operations, including country/site operations and sponsor oversight.

Aufgaben

• Partner with cross-functional teams to align country and site strategies with trial planning and execution.
• Provide strategic and operational leadership for trial execution across European countries and manage risk.
• Lead, coach, and develop CCSLs and country/site resources for accountability and collaboration.
• Represent CSO in country relations with investigators, healthcare institutions, and affiliate leadership.
• Provide country/site intelligence to study teams, including feasibility, enrollment insights, and regulatory considerations.
• Support country and site selection, enrollment planning, and portfolio decisions with evidence-based recommendations.
• Coordinate with CMLs, Site Managers, CRAs, FSPs, and CROs to ensure oversight and consistent execution standards.
• Drive implementation and continuous improvement of the CSO operating model, including SCOUT/IFM.

Kenntnisse

Clinical operations

Leadership

Stakeholder management

GCP/ICH knowledge

Cross-country collaboration

Sponsor oversight

Ausbildung

Bachelor's degree in Life Sciences

Jobbeschreibung

About This Role

The Director, Country & Site Operations (CSO), Europe is accountable for leadership and performance across assigned European countries, supporting Biogen clinical trials across all phases of development and therapeutic areas.

The Director, Country & Site Operations (CSO), Europe is accountable for leadership and performance across assigned European countries, supporting Biogen clinical trials across all phases of development and therapeutic areas.

This role provides strategic and operational leadership to Clinical Country & Site Leads (CCSLs) and country/site operations resources, ensuring strong country delivery, site performance, investigator engagement, affiliate collaboration, and sponsor oversight.

The role serves as the senior CSO operational leader for a sub-regional cluster of countries and provides proactive country intelligence, site insights, risk assessment, and operational recommendations to inform protocol planning, country selection, site strategy, enrollment forecasting, and study execution.

This position partners closely with Worldwide Medical, Clinical Trial Delivery Units (CTDU), Clinical Monitoring Leads (CMLs), Site Managers, FSP partners, CRO partners, and affiliate leadership to support successful delivery of Biogen's clinical trial portfolio and implementation of the CSO operating model, including IFM/SCOUT.

Leadership scope is expected to include approximately 5-8 direct reports and 15-25 indirect or matrixed resources, depending on assigned countries, portfolio needs, and organizational design.

What You’ll Do

• Partner cross-functionally with Country & Site Operations, CTDU, Clinical Development, Worldwide Medical, Affiliate Leadership, Clinical Monitoring, Patient Recruitment, Quality, Regulatory, CRO/FSP partners, investigators, and research sites to align country and site strategies with overall clinical trial planning and execution.
• Provide strategic and operational leadership for clinical trial execution across assigned European countries, ensuring delivery of country objectives, high-quality execution, issue resolution, and proactive risk management.
• Lead, coach, and develop CCSLs and assigned country/site operations resources, fostering accountability, collaboration, operational excellence, innovation, and sustainable workload management.
• Act as the senior CSO representative within assigned countries, maintaining strong relationships with investigators, research sites, healthcare institutions, and affiliate leadership teams to reinforce Biogen's sponsor-of-choice presence.
• Provide proactive country, site, and operational intelligence to study teams and development leadership, including feasibility input, protocol implementation considerations, patient recruitment insights, healthcare landscape changes, competitive trial activity, and operational risks.
• Support country selection, site selection, enrollment planning, and portfolio decision-making through evidence-based recommendations and structured country assessments.
• Partner with CMLs, Site Managers, CRAs, FSP organizations, and CRO partners to support effective trial oversight, escalation pathways, quality expectations, and consistent execution standards.
• Support implementation, governance, and continuous improvement of the CSO operating model, including IFM/SCOUT, ensuring effective collaboration between country, site engagement, monitoring, and study teams.
• Represent CSO in global and regional initiatives, including protocol optimization, investigator engagement, risk-based quality initiatives, operational excellence, and organizational transformation efforts.
• Support resource planning, workforce planning, operational performance tracking, annual objectives, and budget planning within assigned countries, escalating material risks or trade-off decisions as appropriate.

Who You Are

You are a clinical operations leader who thrives in complex, evolving environments and enjoys building structure where processes are still emerging. You combine strong country-level clinical trial expertise with the ability to lead people, influence senior stakeholders, and drive meaningful change. You are accountable for outcomes, comfortable challenging the status quo constructively, and skilled at building trusted partnerships across Medical, Commercial, affiliate leadership, and clinical development teams. Most importantly, you bring a collaborative leadership style and a passion for helping teams succeed together.

Required Skills

• Bachelor's Degree required; advanced degree preferred.
• 12+ years of experience in clinical development or clinical operations, including significant experience in country-facing and site-facing operational roles.
• Experience leading clinical operations activities across multiple countries or a sub-regional cluster is required.
• Experience working with global study teams, affiliate organizations, Medical, Development, Quality, monitoring teams, CRO/FSP partners, and external stakeholders is expected.
• Demonstrated experience managing people and/or matrix teams, with a strong track record of leadership, coaching, talent development, performance management, and operational delivery, is required.
• Deep knowledge of global clinical development and clinical trial operations, including country and site operations, study execution, sponsor oversight, and site engagement.
• Strong understanding of GCP, ICH guidelines, clinical trial regulations, and regulatory guidance pertinent to clinical trial conduct in assigned regions.
• Proven ability to translate country, site, investigator, and affiliate insights into practical operational strategies for study teams and development stakeholders.
• Strong stakeholder management and influencing skills, including experience communicating with senior leaders and cross-functional teams.
• Demonstrated people leadership skills, including coaching, talent development, performance management, and leading through change.
• Ability to support financial/resource planning and operational performance oversight within an assigned sub-region.

Job Level: Management

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.