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 benchmarks in healthcare that enhance the quality of life globally. Our European focus encompasses two primary domains: our Specialty Business aims to safeguard individuals from cardiovascular ailments, the foremost cause of mortality in Europe, while our Oncology division aspires to emerge as a global pharmaceutical innovator, crafting novel treatments for cancer patients. Our European headquarters are strategically located in Munich, Germany, complemented by affiliates in 13 European nations and Canada.
We are in search of exceptionally qualified candidates to assume the following role within our European organization:
Senior Director, Global Clinical Operations (GCO), Europe (m/f/x)
Role Overview:
The Senior Director of Global Clinical Operations (GCO) for Europe is tasked with delivering leadership and operational acumen in the execution of Research & Development (R&D) studies conducted within the European region. This position is integral to the Global Clinical Operations (GCO) division in R&D and is expected to:
- Collaborate with Contract Research Organizations (CROs) to identify, advocate for, and implement essential enhancements in the outsourced operational framework for optimization, performance, and site engagement.
- Strategically assess local requirements and assist in developing resource allocations to effectively support the clinical trial delivery strategy.
- Maintain a high level of visibility regarding operational matters among leadership and stakeholders.
- Guide and inform the strategic direction for a potential insourced clinical trial model for the European region, aligning with global strategies.
The scope of this role encompasses the geographical area of Europe, including European Union (EU) nations and other European territories (e.g., UK, Switzerland, Turkey, Norway), with potential extension to neighboring countries based on business needs.
Key Responsibilities:
- Lead, manage, and drive operational excellence across Europe, ensuring effective CRO delivery and considering future internalization of GCO's operational model where applicable.
- Ensure operational deliverables in Europe align with time, cost, and quality commitments, partnering with internal GCO functions to monitor performance and implement mitigation strategies.
- Serve as a primary escalation point for issues impacting ongoing studies, ensuring critical business milestones are met.
- Support the formulation and direction of a European regional strategy in accordance with global objectives, including resource requirements and capabilities.
- Cultivate strong relationships with Daiichi Sankyo Europe Country Managers, Medical Directors, and other key stakeholders to facilitate collaboration and early operational input into study design and trial execution.
- Assess and highlight country-specific strengths and opportunities in priority Therapeutic Areas, collaborating with the GCO Feasibility team to inform country/site selection strategies.
- In partnership with the global study team, manage European risks and proactively communicate progress, issues, or changes that may affect timelines and costs.
- Provide operational input on EU Clinical Trials Regulations (CTR) and In Vitro Diagnostic Medical Device Regulation (IVDR) to the global team.
- Ensure study-level quality and compliance with Good Clinical Practice (GCP), local laws, and regulations, guiding the team in preparation for local health authority inspections.
- Oversee the regional team in alignment with business needs, which may include GCO roles in study management, site engagement, and other local staff in the European region.
Qualifications:
- A Bachelor's degree is required; an advanced degree is preferred, ideally in a related discipline.
- Over 15 years of industry or related experience, with extensive expertise in early/late-stage drug development, particularly in oncology.
- Knowledge and experience in drug development within the European context.
- Proven experience in line and performance management, including resource and budget planning.
- Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global setting.
- Experience in organizational design and change management.
- Excellent written and verbal communication skills.
- Proven capability to foster successful collaborations with internal and external partners.
Why Choose Daiichi Sankyo?
Working at Daiichi Sankyo transcends mere employment; it represents an opportunity to effect meaningful change and improve patients' lives. We can only realize this ambitious vision together. Therefore, we cultivate 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 insights.
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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 care 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 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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