Director of Global Clinical Operations in Europe
vor 4 Wochen
Passion for Innovation. Compassion for Patients.
With a legacy spanning over 120 years and a workforce exceeding 17,000 across more than 20 nations, Daiichi Sankyo is committed to pioneering, developing, and delivering new standards of care that enhance the quality of life globally. In Europe, our focus is twofold: Our Specialty Business aims to safeguard individuals from cardiovascular ailments, the foremost cause of mortality in Europe, while also assisting patients to cherish every moment of life. In the realm of Oncology, we aspire to emerge as a global pharmaceutical innovator, crafting novel therapies for cancer patients. Our European headquarters are situated in Munich, Germany, complemented by affiliates in 13 European nations and Canada.
We are currently in search of highly qualified candidates for the following role:
Senior Director, Global Clinical Operations (GCO), Europe (m/f/x)
Role Overview:
The Senior Director, Global Clinical Operations (GCO) Europe, is responsible for delivering leadership and operational expertise in the execution of Research & Development (R&D) studies conducted within Europe. This role is integral to the Global Clinical Operations (GCO) team in R&D. Key responsibilities include:
- Collaborating with Contract Research Organizations (CROs) to identify, advocate for, and implement significant enhancements in the outsourced operational model to optimize performance and site engagement.
- Strategizing local requirements and assisting in the development of resource needs to effectively support the clinical trial delivery strategy.
- Ensuring high visibility of operational matters among leadership and stakeholders.
- Leading and guiding the direction and strategy for a potential insourced clinical trial model in alignment with global objectives.
The scope of this role encompasses the geographical region of Europe, including European Union (EU) countries and other European nations (e.g., UK, Switzerland, Turkey, Norway). It may also extend to neighboring countries depending on business requirements.
Key Responsibilities:
- Accountable for leading, managing, and driving operational excellence across Europe through CRO delivery and considerations for future internalization of GCO's operational model.
- Overseeing operational deliverables in Europe in accordance with time, cost, and quality commitments, partnering with internal GCO functions to monitor performance and implement mitigation strategies.
- Acting as a primary point of escalation for issues and problem resolution affecting new and ongoing studies to ensure critical milestones are met.
- Supporting the creation and direction of a European regional strategy in accordance with global objectives, including resource requirements and capabilities.
- Fostering strong relationships with Daiichi Sankyo Europe Country Managers, Medical Directors, and other key stakeholders to ensure effective collaboration and early operational input into study design and trial execution.
- Conducting feasibility assessments by understanding and highlighting country-specific strengths and opportunities in priority Therapeutic Areas.
- Maintaining European risk oversight in partnership with the global study team, proactively communicating progress and changes that may impact timelines and costs.
- Providing operational input for EU Clinical Trials Regulations (CTR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
- Ensuring study-level quality and compliance with GCP, local laws, and regulations while guiding the team in local inspection readiness.
- Managing a regional team in alignment with business needs, which may include GCO roles in study management and site engagement.
Qualifications:
- Bachelor's degree required; advanced degree preferred in a related discipline.
- 15+ years of industry or related experience, with extensive early/late-stage drug development oncology experience.
- Knowledge and experience in drug development within the European region.
- Proven line and performance management experience, including resource and budget planning.
- Demonstrated ability to set and manage priorities, resources, and performance targets in a global context.
- Strong organizational design and change management experience.
- Excellent written and verbal communication skills.
- Proven capability to cultivate successful collaborations with internal and external partners.
Why Consider a Career with Us?
At Daiichi Sankyo, working with us transcends the conventional job experience – it is an opportunity to make a meaningful impact and enhance patients' lives. We believe that achieving our ambitious goals requires collaboration. Thus, we nurture a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the chance to grow, think innovatively, and contribute your ideas.
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Director of Global Clinical Operations in Europe
vor 4 Wochen
Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitPassion for Innovation. Compassion for Patients. Daiichi Sankyo is a global leader in the pharmaceutical industry with over 120 years of experience and a workforce exceeding 17,000 across more than 20 countries. Our mission is to discover, develop, and deliver innovative healthcare solutions that enhance the quality of life for patients worldwide. In Europe,...
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Director of Global Clinical Operations in Europe
vor 4 Wochen
Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitPassion for Innovation. Compassion for Patients. With a legacy spanning over 120 years and a workforce exceeding 17,000 across more than 20 nations, Daiichi Sankyo is committed to pioneering, developing, and delivering new standards of healthcare that enhance the quality of life globally. In Europe, our focus is twofold: our Specialty Business aims to...
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Director of Global Clinical Operations in Europe
vor 4 Wochen
Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitPassion for Innovation. Compassion for Patients. With a legacy spanning over 120 years and a workforce exceeding 17,000 across more than 20 nations, Daiichi Sankyo is committed to pioneering, developing, and delivering new benchmarks in healthcare that enhance the quality of life globally. Our European focus encompasses two primary domains: our...
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vor 4 Wochen
Munich, Bayern, Deutschland Daiichi Sankyo Europe VollzeitPassion for Innovation. Compassion for Patients. Daiichi Sankyo is a global leader in the pharmaceutical industry with over 120 years of experience and a workforce exceeding 17,000 employees across more than 20 countries. Our mission is to discover, develop, and deliver innovative healthcare solutions that enhance the quality of life for patients worldwide....
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