Senior Manager, Clinical Site Partner
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Senior Manager, Clinical Site Partner (Italy)
Azienda : Summit Therapeutics Plc
Tipo Lavoro : Full Time Italy
Descrizione Lavoro - Senior Manager, Clinical Site Partner (Italy)
About Summit:Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
- HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
- HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
- HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
- HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Role Overview
The Senior Manager, Clinical Operations Site Partner (CSP) is responsible for providing leadership and operational expertise in the execution of one or more Phase I–III clinical trials across the European region.
As a key member of the Global Clinical Operations (GCO) group and reporting to the Senior Director, Clinical Operations (Europe), the Senior Manager CSP plays a pivotal role in ensuring operational excellence in trial conduct and site performance.
This position serves as the primary Summit operational point of contact for assigned clinical trial sites, with full accountability for the end-to-end lifecycle of studies. The role drives site selection, site start-up efficiency, accelerates site activation, recruitment, and maintains high standards of performance and quality throughout the study lifecycle.
The Senior Manager CSP acts as a strategic partner to sites and study teams—helping Summit achieve its vision of becoming a Sponsor of Choice by delivering a concierge-level experience to our clinical trial sites.
Key Responsibilities
- Serve as the main operational contact for assigned clinical trial sites across Europe.
- Provide leadership and oversight for all operational aspects of site performance, from feasibility through study closeout.
- Recommend sites based on indication, experience, capabilities, and local knowledge.
- Engage with feasibility assessments and site selection activities.
- Involve sites early to gather feedback on protocol design, recruitment expectations, and local practices.
- Drive efficiency in study start-up and expedite site activation timelines.
- Maintain deep knowledge of site capabilities, processes, and requirements.
- Expertise in European clinical trial and country-specific regulations and guidelines.
- Act as a facilitator between Summit functions and site teams to ensure seamless communication and coordination.
- Participate in site visits, investigator meetings, and study-related interactions as required.
- Proactively identify and address obstacles impacting site recruitment and performance.
- Track key performance metrics to assess site progress, mitigate potential risks, and implement corrective actions.
- Develop and deploy effective strategies to improve site engagement and performance.
- Deliver concierge-level support to sites, ensuring an optimal partnership experience.
- Contribute to continuous improvement initiatives within Clinical Operations.
- Perform all other duties as assigned.