Join to apply for the Director, Clinical Operations EU & Partner Liaison role at Summit Therapeutics, Inc.
About Summit
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining immunotherapy via PD-1 blockade with anti-angiogenesis effects by blocking VEGF. It displays unique cooperative binding with higher affinity when both targets are present. Summit has initiated clinical development in non-small cell lung cancer (NSCLC), with three active Phase III trials:
HARMONi : Evaluates ivonescimab with chemotherapy vs. placebo plus chemotherapy in EGFR-mutated NSCLC patients post 3rd gen EGFR TKI treatment.
HARMONi-3 : Assesses ivonescimab with chemotherapy vs. pembrolizumab with chemotherapy in first-line metastatic NSCLC.
HARMONi-7 : Compares ivonescimab monotherapy to pembrolizumab in first-line metastatic NSCLC with high PD-L1 expression.
Ivonescimab is investigational, not yet approved in the US or Europe, but approved in China as of May 2024. It has received Fast Track designation from the FDA for the HARMONi trials.
Role Overview
We seek a highly qualified Director, Clinical Operations EU & Partner Liaison to oversee Phase 3 global oncology trials in collaboration with our Chinese partner. This role will be the primary contact for clinical operations in China, working closely with the partner. The candidate should have extensive experience in Phase 3 trials, excellent communication skills in Mandarin and English, and the ability to manage cross-cultural and cross-border collaborations.
Responsibilities
Serve as the main contact for clinical operations deliverables and timelines for global studies in partnership with China and Europe.
Coordinate with the Chinese partner to integrate China into global trial operations.
Manage a team of Clinical Site Partners in Europe.
Develop and implement EU Clinical Operations Strategy.
Ensure clear communication across teams and with partners.
Monitor progress, address operational challenges, and ensure compliance with protocols and standards.
Lead operational meetings and facilitate collaboration.
Manage regulatory timelines, vendors, and training activities.
Collaborate with cross-functional teams to meet milestones.
Maintain understanding of Chinese and EU regulations impacting trials.
Travel to China and EU as needed.
Serve as the study planning expert for China & EU enrollment.
Qualifications
Bachelor’s degree in a scientific discipline or related field.
At least 10 years of experience in clinical operations, especially in managing Phase III oncology trials.
Fluent in Mandarin and English.
Proven communication, negotiation, and collaboration skills, especially in China.
Strong understanding of conducting trials in China.
Excellent project management and problem-solving skills.
Proficiency in Microsoft Office.
Cultural Competence
Understanding of Chinese business culture.
Ability to work effectively across cultures.
Build trust with international partners.
Preferred
Experience working in partnership models for clinical trials in China.
Additional Details
Seniority level: Director
Employment type: Full-time
Job function: Strategy/Planning and IT
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