Director of Clinical Operations, Spain

Job Title: Director, Clinical Operations, Spain

Department: Clinical Operations

Location: Remote Spain

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate phase-III clinical studies.

Overview of Role:

The Director, Clinical Operations Europe, is accountable for providing leadership and operational expertise into execution of one or more phase 1-3 clinical trials conducted in Europe. The role will be part of the Global Clinical Operations (GCO) group reporting into USA VP, Head of Clinical Operations. 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 (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.

This position could preferably be filled either in Summit UK Office in Oxfordshire, UK, or in Spain.

Role and 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.
• 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 Summit Study Leads and Study Cross-Functional Teams. 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 the creation of the strategy for selection of countries/sites for Europe.
  • 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.
• 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.

Experience, Education and Specialized Knowledge and Skills:

• BA/BS required; in a scientific/medical field preferred.
• 10+ years industry or related experience. Extensive early/late-stage drug development oncology experience ideally including time in role such as a Local or Global Study 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.
• Proven ability to develop successful collaborations with internal and external partners.

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