Director of Global Clinical Operations in 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 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 dedicated to two primary areas: our Specialty Business, which aims to combat cardiovascular diseases, and our Oncology division, where we aspire to lead in pharmaceutical innovation by developing novel 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 for Europe will provide strategic leadership and operational guidance for the execution of Research & Development (R&D) studies within the region. This role is integral to the Global Clinical Operations (GCO) team in R&D and is expected to:
- Collaborate with Contract Research Organizations (CROs) to identify and implement enhancements in the outsourced operational model, focusing on optimization, performance, and site engagement.
- Assess local requirements and contribute to building the necessary resources to effectively support clinical trial delivery strategies.
- 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 member states and other European nations. It may also extend to neighboring countries based on business requirements.
Key Responsibilities:
- Lead and drive operational excellence across Europe, focusing on CRO delivery and evaluating future internalization of GCO's operational framework.
- Ensure operational deliverables are met in Europe, adhering to 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 formulation of a European regional strategy that aligns with global objectives, including resource needs and capabilities.
- Establish strong relationships with key stakeholders across Daiichi Sankyo Europe to facilitate collaboration and operational input into study design and execution.
- Conduct feasibility assessments, leveraging country-specific insights to inform operational plans for effective delivery.
- Work closely with the global study team to manage European risks, communicating progress and identifying trends that may impact timelines and costs.
- Provide input on EU Clinical Trials Regulations and In Vitro Diagnostic Medical Device Regulation.
- Ensure compliance with 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 various GCO roles.
Qualifications:
- Bachelor's degree required; advanced degree preferred in a relevant field.
- 15+ years of industry experience, with extensive knowledge in early and late-stage drug development, particularly in oncology.
- Demonstrated experience in drug development within the European context.
- Proven track record in line and performance management, including resource and budget oversight.
- Strong organizational skills with the ability to manage priorities and project initiatives in a global setting.
- Excellent communication skills, both written and verbal.
- Ability to foster successful collaborations with internal and external partners.
Why Choose Daiichi Sankyo?
At Daiichi Sankyo, we believe in making a meaningful impact on patients' lives. Our culture promotes mutual respect, continuous learning, and a commitment to inclusion and diversity. Here, you will have the opportunity to innovate, contribute your ideas, and grow professionally.
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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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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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Director of Global Clinical Operations for 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 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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