Amgen
Biotechnology
HeadofStudyOperations(m/w/d)DACHHub
“Head of Study Operations (m/w/d) - DACH Hub at Amgen. Skills: strategic and operational responsibility for the execution of clinical studies and site activities in the DACH region, leadership of the DACH Hub team, management of budget, forecast, and vendors. Strategic and operational overall responsibility for the execution of clinical studies and site activities in the DACH region. Ensuring the timely implementation of the study portfolio in accordance with global strategies, regulatory require”
What You'll Achieve.
timely implementation of the study portfolio; ensuring compliance; inspection readiness; continuous improvement
Industry & Context.
strategic competence; analytical competence; organizational competence
What They're Looking For.
Must Have
natural science or medical university degree, at least 8 years of experience in clinical research, strong communication skills in German and English (written and spoken; approx. C1 level), strong strategic, analytical, and organizational competence, strong assertiveness and confident demeanor towards internal and external stakeholders at national and international level
Nice to Have
PhD, at least 4 years of leadership experience with disciplinary responsibility or proven leadership of complex teams, programs, or projects, experience in managing external service providers (e.g., CROs, laboratories, imaging providers), comprehensive experience in managing clinical operations in the DACH region, including in-depth knowledge of local regulatory requirements in connection with global clinical studies
What You'll Do.
Strategic and operational overall responsibility for the execution of clinical studies and site activities in the DACH region
Ensuring the timely implementation of the study portfolio in accordance with global strategies
regulatory requirements
and Amgen quality standards
Overall responsibility for study start-up
Strategic advice on study site placement
and site selection in close alignment with global portfolio priorities and regional strengths
Professional and disciplinary leadership
and succession planning of the DACH Hub team
Ensuring adequate resource planning and allocation in close cooperation with global partners
Responsibility for budget
and efficient use of resources at the country level
Leadership of governance and risk management processes (e.g.
Country Management Team)
and continuous improvement
How You'll Work.
Team & Collaboration
Close cooperation with global partners; Interaction with internal and external stakeholders at national and international level
Communication Scope
strong communication skills in German and English (written and spoken; approx. C1 level); confident demeanor towards internal and external stakeholders at national and international level
Process & Methodology
management of complex teams, programs, or projects, governance processes, risk management processes
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