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 healthcare that enhance the quality of life globally. In Europe, our focus is twofold: our Specialty Business aims to shield individuals from cardiovascular ailments, the predominant cause of mortality in Europe, while also assisting those affected to cherish every moment of life. In the realm of Oncology, we aspire to emerge as a global pharmaceutical innovator, creating groundbreaking 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 exceptionally qualified candidates to fulfill the following role:
Senior Director, Global Clinical Operations (GCO), Europe (m/f/x)
Position Overview:
The Senior Director of Global Clinical Operations (GCO) for Europe is responsible for providing strategic leadership and operational proficiency in the execution of Research & Development (R&D) studies conducted across Europe. This role is integral to the Global Clinical Operations (GCO) team within R&D. Key responsibilities include:
- Collaborating with Contract Research Organizations (CROs) to identify, advocate for, and implement significant enhancements in the outsourced operational framework for optimization, performance, and site engagement.
- Strategizing local requirements and assisting in the development of resource needs to effectively support the clinical trial delivery strategy in a compliant and efficient manner.
- Maintaining a high level of visibility regarding operational matters among leadership and stakeholders.
- Leading and shaping the direction and strategy for a potential insourced clinical trial model for the European region 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). The scope may extend to neighboring countries depending on business requirements.
Key Responsibilities:
- Accountable for leading, managing, and driving operational excellence across Europe, achieved through CRO delivery and considerations for the future internalization of GCO's operational model where appropriate.
- Responsible for operational deliverables in Europe, ensuring adherence to time, cost, and quality commitments. Collaborate with internal GCO functions to monitor performance and implement mitigation strategies as necessary.
- Serve as a primary point of escalation for issues and problem resolution affecting new and ongoing studies, ensuring critical business milestones are met.
- In line with global strategy, support the development and direction of a European regional strategy, including resource requirements and capabilities.
- Foster 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 execution.
- Feasibility: Identify and highlight country-specific strengths and opportunities in priority Therapeutic Areas while collaborating with the GCO Feasibility team to create strategies for country/site selection.
- In partnership with the global study team, maintain awareness of European risks, proactively communicate progress, issues, or changes that may impact timelines and costs.
- Support the global team with operational input regarding EU Clinical Trials Regulations (CTR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
- Ensure study-level quality and compliance with Good Clinical Practice (GCP), local laws, and regulations, guiding the team in local Health Authority inspection readiness.
- Oversee the regional team in alignment with business needs, which may include GCO roles in study management, site engagement, and other local staff within the European region.
Education & Professional Experience:
- Bachelor's degree required; advanced degree preferred. A Bachelor of Science/Master of Science in a related discipline or equivalent work experience is ideal.
- 15+ years of industry or related experience, with extensive early/late-stage drug development oncology experience, ideally including roles such as Local or Global Project Leader.
- Knowledge and experience in drug development within the European region.
- Proven line and performance management experience, including functional management, resource management, and budget oversight.
- Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global context.
- Proven experience in organizational design and change management.
- Excellent written and verbal communication skills.
- Proven ability to cultivate successful collaborations with internal and external partners.
Why Consider This Opportunity?
At Daiichi Sankyo, working with us is more than just a job; it is an opportunity to make a meaningful impact and improve patients' lives. We believe that achieving this ambitious goal requires collaboration. Therefore, 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 share your ideas. If you possess a proactive mindset and a passion for addressing patient needs, we look forward to your interest in this opportunity.
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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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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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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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