Sr Director, Country & Site Operations (CSO)
Job Location:
Baar - Switzerland
Monthly Salary:
Posted on:
Vacancies:
Job Summary
The 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 countrylevel execution issue resolution and continuous performance improvement. The CCSL fieldbased is a core pillar of the role with accountability for maintaining strong investigator and site relationships driving site intelligence and reinforcing Biogens 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 countrys 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 operatingmodel 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.
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 onto learn more about our DE&I efforts.
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.
Required Experience:
Exec
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
