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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 Summit's 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:

We are seeking a highly qualified and experienced Director, Clinical Operations EU & Partner Liaison to ensure the successful execution of our Phase 3 global Oncology clinical trials in collaboration with our partner company in China. This crucial role will serve as the primary point of contact for all clinical operations deliverables and timelines related to our Phase 3 studies in China, working closely with the Chinese partner company. The ideal candidate will possess a comprehensive understanding of Phase 3 clinical trial operations, exceptional communication and collaboration skills, fluency in Mandarin Chinese & English, and a proven track record of managing deliverables and timelines within a partnership framework in China. The successful candidate should be adept at navigating US-Chinese cross-cultural business environments and demonstrate sufficient flexibility and adaptability to accommodate business needs concerning time zones.

Role and Responsibilities:

Serve as the primary point of contact for all clinical operations deliverables and timelines related to Phase 3 global studies being conducted in partnership with our Chinese partner company and in Europe
Work in close collaboration with the Chinese partner company to ensure the seamless integration of China into the operational aspects of global Phase 3 clinical trials
Manage a team of Clinical Site Partners in Europe.
Define, Develop and Establish EU Clinical Operations Strategy
Collaborate closely with SMT Leads and ensure information is clearly communicated to the Teams
Develop and maintain a deep understanding of the collaborative agreement and respective responsibilities related to clinical operations deliverables and timelines
Proactively monitor, track, and report progress against agreed-upon deliverables and timelines for the China component of global Phase 3 studies
Facilitate timely, clear and consistent communication between internal global study teams and the clinical operations teams at the Chinese partner company and in EU
Identify and address any potential operational challenges or timeline delays related to the Phase 3 studies, working collaboratively with the partner company to develop and implement solutions
Ensure that all clinical operations activities in China & EU align with the global study protocols, timelines, and quality standards
Support the development and adaptation of study-related operational plans and materials in collaboration with the Chinese partner company, ensuring study process harmonization as well as local, cultural and linguistic appropriateness
Organize and lead operational, vendor, and or cross functional meetings and discussions with Chinese and European partners as needed
Facilitate joint operational meetings and discussions with the Chinese partner company to review progress, address issues, and ensure alignment
Manage and facilitate all actions around regulatory timelines, vendors, communications and plans training
Collaborate with cross-functional teams (e.g., Clinical Development, Regulatory Affairs, Data Management, etc), vendors, and the Chinese partner company to ensure the timely and high-quality delivery of clinical operations milestones in China
Maintain a strong understanding of relevant Chinese & EU regulations and guidelines impacting Phase 3 clinical trial operations and ensure alignment with the partner company or other sites
Contribute to the development of best practices for managing clinical operations deliverables and timelines within international partnerships, specifically focusing on China & EU
Potentially travel to China and EU as required to facilitate collaboration and oversee operational activities with the partner company
Become the go-to person in Summit for study planning for studies involving enrollment in China & EU.
All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

Bachelor's degree in a scientific discipline or related field
Minimum of 10+ years of progressive experience in clinical operations within the pharmaceutical or biotechnology industry, with significant experience in managing Global Phase III oncology clinical trials
Fluency in both spoken and written Mandarin & English is essential
Proven ability to effectively communicate, negotiate, and collaborate with external partners, particularly in China
Strong understanding of the operational aspects of conducting Phase 3 clinical trials in China
Excellent project management, organizational, and time management skills, with a focus on delivering against timelines
Strong problem-solving skills and the ability to work collaboratively to find solutions
Excellent written and verbal communication skills in English
Ability to work independently and collaboratively within a global, matrixed environment.
Highly proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

Cultural Competence:

Understanding of Chinese business culture and practices
Ability to work effectively in a cross-cultural environment
Sensitivity to cultural differences and the ability to build trust and rapport with partners

Preferred Qualifications:

Direct experience working in a partnership model for clinical trials in China

Summit Therapeutics Sub, Inc.

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