Clinical Operations Director for Europe

hace 4 días

Madrid, Madrid, España Summittherapeutics A tiempo completo
Job Title:
Director, Clinical Operations, Europe

Department:

Clinical Operations Location:
Remote

Overview of Role:

The Director, Clinical Operations Europe, is accountable for providing leadership and operational expertise into the execution of one or more phase 1-3 clinical trials conducted in Europe.

This role will be part of the Global Clinical Operations (GCO) group, reporting into the USA VP, Head of Clinical Operations.


This position is expected to:

Collaborate with Contract Research Organizations (CROs) to 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 a 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 (EU) countries and other European countries (e.g. UK, Switzerland, Turkey, Norway).

Scope may include other geographical neighboring countries to Europe depending on business needs.


Role and Responsibilities:

Accountable to lead, manage and drive operational excellence in Europe 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.

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.

Support the creation and direct on a European regional strategy including resource requirements and capabilities needed in accordance with the global strategy and pace.

Build strong relationships with Summit Study Leads and Study Cross-Functional Teams to guide operational direction of disease area expertise and country-specific needs.


Feasibility:

Understand and highlight country-specific strengths and opportunities in the strategy for selection of countries/sites for Europe.

Ensure timely inclusion of robust regional/country-level insights and feasibility outcomes into the operational plans for effective delivery.

In partnership with the global study team, maintain European risks, proactively communicate progress, issues or changes that may impact timelines and costs, and support mitigation of systemic issues and risks.

Accountable for study-level quality and compliance with GCP, local laws and regulations, guiding the team with local HA inspection readiness

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