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Sr director, country & site operations (cso)

Baar (Zug)
Biogen
Inserat online seit: 10 Juni
Beschreibung

PpThe Sr Director, Country Site Operations (CSO), European Markets, is accountable for leadership and performance of country and site operations across assigned European markets, supporting Biogen clinical trials across all phases of development and therapeutic areas. This role provides strategic and operational leadership to regionally based clinical country leaders and Clinical Country Site Leads (CCSLs), ensuring strong country delivery, site performance, and sponsor oversight. 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. /p h3Key Responsibilities /h3 ul liAccountable for CSO country’s performance across assigned European markets, including delivery governance, risk management, and resolution of operational issues. /li liLeads and develops people managers and country/site leadership to ensure consistent execution, capability development, and sustainable workloads. /li liPreserves and strengthens CCSL site engagement, sponsor oversight, and site intelligence to inform site selection and portfolio decisions. /li liProvides oversight of monitoring delivery (CRA/CML; FTE/FSP) and ensures structured collaboration between CCSLs, country leaders, and monitoring teams. /li liPartners with CRO and FSP providers drive operational excellence, monitoring effectiveness, and site performance. /li liDrives and implements CSO initiatives and operating‑model changes with global applicability, supporting standardization and continuous improvement. /li liOwns budget and headcount planning for the Europe markets organization and contributes to broader CSO workforce planning. /li liPartner with other CSO Leaders in EU (including EU-CTR functions) to drive quality and consistency of the team. /li /ul h3Leadership Scope /h3 ul liLeads a management organization and CCSL/country delivery teams across European markets, with indirect oversight of monitoring resources supporting the region. /li /ul h3Education Requirements /h3 ul liUniversity degree or the equivalent combination of education and experience required; advanced/graduate degree preferred. /li /ul h3Minimum Experience Requirements /h3 ul liRequires 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. /li liSignificant ability for strategic planning, ability to influence. /li liAbility to collaborate across many functions. /li liExperienced people manager. /li liStrong understanding of regulatory environment regarding GCP, clinical trial regulations and regulatory guidance pertinent to clinical trial conduct in assigned region. /li liStrong project management skills and experience leading internal and external global cross-functional projects. /li liStrong interpersonal and communication skills, including experience working with various levels of senior management. /li /ul pJob Level: Management /p pAll 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. /p /p #J-18808-Ljbffr

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