Director of Global Clinical Operations for Europe
vor 4 Wochen
Passion 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. In Europe, we are committed to two primary areas: our Specialty Business, which aims to combat cardiovascular diseases, and our Oncology division, where we strive to be a global innovator in cancer therapies.
We are currently seeking a highly qualified individual for the role of:
Senior Director, Global Clinical Operations (GCO), Europe (m/f/x)
Position Overview:
The Senior Director of Global Clinical Operations (GCO) for Europe will provide strategic leadership and operational expertise in the execution of Research & Development (R&D) studies across the region. This role is integral to the Global Clinical Operations (GCO) team within R&D and is expected to:
- Collaborate with Contract Research Organizations (CROs) to identify and implement key enhancements in the outsourced operational model for improved performance and site engagement.
- Assess local requirements and develop resource strategies to support the clinical trial delivery framework effectively and compliantly.
- Maintain high visibility of operational matters among leadership and stakeholders.
- Guide the strategic direction for a potential insourced clinical trial model in alignment with global objectives.
This role encompasses the geographical scope of Europe, including EU countries and other European nations. It may also extend to neighboring regions based on business requirements.
Key Responsibilities:
- Lead and manage operational excellence initiatives across Europe, focusing on CRO delivery and the potential internalization of GCO's operational model.
- Ensure operational deliverables in Europe meet time, cost, and quality standards while partnering with internal GCO functions to monitor performance and develop mitigation strategies.
- Act as a primary escalation point for issues affecting ongoing studies, ensuring critical milestones are achieved.
- Support the development of a European regional strategy in accordance with global objectives, including resource needs and capabilities.
- Foster strong relationships with Daiichi Sankyo Europe Country Managers and other key stakeholders to ensure effective collaboration and operational input into study design and execution.
- Conduct feasibility assessments, highlighting country-specific strengths and opportunities while collaborating with the GCO Feasibility team.
- Work with the global study team to manage European risks, proactively communicating progress and identifying trends that may impact timelines and costs.
- Provide operational input on EU Clinical Trials Regulations (CTR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
- Ensure compliance with GCP, local laws, and regulations, guiding the team in inspection readiness.
- Oversee the regional team in alignment with business needs, including roles in study management and site engagement.
Qualifications:
- Bachelor's degree required; advanced degree preferred in a related field.
- 15+ years of industry experience, with extensive knowledge in early and late-stage drug development, particularly in oncology.
- Proven experience in drug development within the European context.
- Demonstrated line and performance management skills, including resource and budget oversight.
- Ability to set and manage priorities and performance targets in a global environment.
- Strong organizational design and change management experience.
- Excellent communication skills, both written and verbal.
- Proven track record of developing successful collaborations with internal and external partners.
Why Choose Daiichi Sankyo?
At Daiichi Sankyo, we believe in making a difference in patients' lives. Our culture promotes mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, innovate, and contribute your ideas in a supportive environment.
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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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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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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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