Senior Director, Global Clinical Operations Europe

vor 2 Wochen

Munich, Deutschland Daiichi Sankyo Europe Vollzeit

The Senior Director, Global Clinical Operations (GCO) Europe, is accountable for providing leadership and operational expertise into execution of Resarch & Development (R&D) studies conducted in Europe. The role will be part of the Global Clinical Operations (GCO) group in R&D. This position is expected to:

- Collaborate with Contract Research Organization (CROs) and identify, champion, and implement key improvements in the outsourced operating model for optimization, performance, and site engagement.
- Strategize local needs and help build resource needs to support the clinical trial delivery strategy in an effective, efficient, and compliant manner.
- Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.
- Lead and inform the direction & strategy for a potential insourced clinical trial model for the Europe region in alignment with global strategy.

Scope of this role includes the geographical region of Europe, inclusive of European Union (EU0 countries and other European countries (e.g. UK, Switzerland, Turkey, Norway). Scope may include other geographical neighboring countries to Europe depending on business needs.

This position could preferably be filled either in Daiichi Sankyo Europe’s headquarters in Munich, Germany, or in France. Applications from other countries in Europe with a Daiichi Sankyo presence are welcome, please check our website to see the Daiichi Sankyo office locations.

**Roles & Responsibilities**:

- Accountable to lead, manage and drive operational excellence in Europe. This will be accomplished through CRO delivery and considerations of future internalization of GCO’s operating model where appropriate.
- Responsible for operational deliverables in Europe in accordance with time, cost, and quality commitments. Partner with internal GCO functions (e.g Clinical Trial Business Operations Performance and Delivery, and Alliance Strategic Vendor Oversight (SVO)) to monitor Europe’s performance as planned, including mitigation strategies.
- Function as a key point of escalation for issues and problem resolution impacting new and ongoing studies to ensure business critical milestones are achieved for Europe.
- In accordance with the global strategy and pace, support the creation and direct on a European regional strategy including resource requirements and capabilities needed.
- Build strong relationships with Daichi Sankyo Europe (DSE) Country Managers, Medical Directors and Regulatory, Clinical Development, Clinical Sciences, Regulatory, Biostats, Data Management, and other key stakeholder peer functions to ensure strong collaboration and early operational input into study design and trial delivery planning and execution. He/she will leverage this information to help guide in operational direction of disease area expertise and country specific expertise specific to European GCO needs.
- Feasibility:

- Understands and highlights country specific strength and opportunities in priority Therapeutic Areas while collaborating with the GCO Feasibility team in the creation of the strategy for selection of countries/sites.
- Ensures timely inclusion of robust regional/country-level insights and feasibility outcomes into the operational plans to enable effective and efficient delivery to plan.
- In partnership with the global study team, maintains European risks, proactively communicates progress, issues or changes that may impact timelines and costs. Identifies trends & patterns across study and program level and supports mitigation and prevention of European specific systemic issues and risks.
- Support the global team with EU Clinical Trials Regulations (CTR) and In Vitro Diagnostic Medical Device Regulation (IVDR) operational input.
- Accountable for the study level quality, and compliance with GCP, local laws and regulations and guide the team with local HA inspection readiness.
- Line management of regional team in line with business needs. This may include but not limited to GCO roles in the following areas - study management, site engagement, and/or other local staff working from the European region.

**Education & Professional Experience**:

- Bachelor’s degree required. Advanced degree preferred. Bachelor of Science/Masters of Science in related discipline, or equivalent work experience.
- 15+ years industry or related experience. Extensive early/late-stage drug development oncology experience ideally including time in role such as a Local or Global Project Leader.
- Knowledge and experience of drug development in European region.
- Proven line and performance management experience. Functional management experience, managing resourcing and budget planning and oversight.
- Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment.
- Proven organization design and change management experience.
- Excellent written and verbal communication skills.
- Prov

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