Sr. Director, Clinical Operations, Europe
Sr. Director, Clinical Operations, Europe
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
About Summit:
Ivonescimab known as SMT112 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. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC) with three active Phase III trials:
- HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g. osimertinib).
- HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
- HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.
Overview of Role:
The Sr. 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 Sweden). 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 remote UK.
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 GCOs 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 levels 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 CTMs and Clinical Site Partners overseeing the European region.
Experience Education and Specialized Knowledge and Skills:
- BA/BS required; in a scientific/medical field preferred.
- 12 years industry or related experience. Extensive early/late-stage drug development oncology experience ideally including time in role such as a Project Delivery 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.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Director
Employment Type
Full Time
