Senior Director, Global Clinical Operations Europe
vor 4 Wochen
About the Role:
We are seeking a highly experienced Senior Director to lead our Global Clinical Operations team in Europe. As a key member of our R&D organization, you will be responsible for providing strategic leadership and operational expertise to ensure the successful execution of clinical trials in Europe.
Key Responsibilities:
- Collaborate with Contract Research Organizations (CROs) to identify and implement key improvements in the outsourced operating model for optimization, performance, and site engagement.
- Develop and implement local strategies to support clinical trial delivery in Europe, ensuring effective, efficient, and compliant execution.
- Lead and inform the direction and strategy for a potential insourced clinical trial model for the Europe region, aligning with global strategy.
- Manage and drive operational excellence in Europe, partnering with internal GCO functions to monitor performance and implement mitigation strategies.
- Function as a key point of escalation for issues and problem resolution impacting new and ongoing studies, ensuring business-critical milestones are achieved for Europe.
- Support the creation and implementation of a European regional strategy, including resource requirements and capabilities needed.
- Build strong relationships with Daiichi Sankyo Europe Country Managers, Medical Directors, and other key stakeholders to ensure collaboration and early operational input into study design and trial delivery planning and execution.
- Identify and highlight country-specific strengths and opportunities in priority therapeutic areas, collaborating with the GCO Feasibility team to create a strategy for selection of countries/sites.
- Proactively communicate progress, issues, or changes that may impact timelines and costs, identifying trends and patterns across study and program levels to support mitigation and prevention of European-specific systemic issues and risks.
- Support the global team with EU Clinical Trials Regulations (CTR) and In Vitro Diagnostic Medical Device Regulation (IVDR) operational input.
- Accountable for study-level quality and compliance with GCP, local laws, and regulations, guiding the team with local HA inspection readiness.
Requirements:
- Bachelor's degree required; advanced degree preferred.
- 15+ years industry or related experience, with extensive early/late-stage drug development oncology experience, ideally including time in a Local or Global Project Leader role.
- Knowledge and experience of drug development in the European region.
- Proven line and performance management experience, including functional management, resourcing, and budget planning and oversight.
- Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global environment.
- Proven organization design and change management experience.
- Excellent written and verbal communication skills.
- Proven ability to develop successful collaborations with internal and external partners.
About Daiichi Sankyo Europe:
Daiichi Sankyo is a global pharmaceutical company dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: protecting people from cardiovascular disease and helping patients with cancer. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
Why Work with Us:
At Daiichi Sankyo, we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. We offer a dynamic work environment where you can grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
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