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- Tasks: Lead global oncology trials and manage cross-cultural collaborations.
- Company: Summit Therapeutics is pioneering innovative cancer treatments with a focus on immunotherapy.
- Benefits: Enjoy a full-time role with opportunities for international travel and professional growth.
- Why this job: Join a cutting-edge company making a real impact in cancer treatment while working with diverse teams.
- Qualifications: 10+ years in clinical operations, fluent in Mandarin and English, with strong project management skills.
- Other info: This role offers a unique chance to work closely with partners in China and Europe.
The predicted salary is between 72000 - 108000 £ per year.
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
Sr. Director, Clinical Operations, Europe employer: Summit Therapeutics, Inc.
Contact Detail:
Summit Therapeutics, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr. Director, Clinical Operations, Europe
✨Tip Number 1
Familiarise yourself with the specific clinical trial landscape in both Europe and China. Understanding the regulatory requirements and cultural nuances will help you stand out as a candidate who is not only knowledgeable but also adaptable to cross-border collaborations.
✨Tip Number 2
Network with professionals in the oncology field, especially those who have experience with Phase III trials. Attend relevant conferences or webinars where you can connect with industry leaders and gain insights that could be beneficial for your application.
✨Tip Number 3
Brush up on your Mandarin communication skills if needed. Since fluency in Mandarin is a requirement, demonstrating your language proficiency during any informal discussions or networking events can significantly enhance your candidacy.
✨Tip Number 4
Research Summit Therapeutics and their ongoing trials thoroughly. Being able to discuss their projects, particularly ivonescimab and its implications in oncology, will show your genuine interest in the role and the company, making you a more compelling candidate.
We think you need these skills to ace Sr. Director, Clinical Operations, Europe
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in clinical operations, particularly in managing Phase III oncology trials. Emphasise your fluency in Mandarin and English, as well as any relevant project management skills.
Craft a Compelling Cover Letter: In your cover letter, explain why you are the perfect fit for the Director, Clinical Operations role. Discuss your understanding of both Chinese and EU regulations, and how your cultural competence will benefit cross-border collaborations.
Highlight Relevant Experience: When detailing your work history, focus on specific examples of your involvement in global studies, especially those that required collaboration with international partners. Mention any successful outcomes from your previous roles.
Showcase Communication Skills: Since excellent communication is key for this role, provide examples of how you've effectively communicated across cultures and managed teams. Highlight any negotiation experiences that demonstrate your ability to build trust with international partners.
How to prepare for a job interview at Summit Therapeutics, Inc.
✨Showcase Your Experience in Phase III Trials
Make sure to highlight your extensive experience in managing Phase III oncology trials. Be prepared to discuss specific challenges you've faced and how you overcame them, as this will demonstrate your capability to handle the responsibilities of the role.
✨Demonstrate Cross-Cultural Communication Skills
Since this role involves collaboration with a Chinese partner, it's crucial to showcase your fluency in Mandarin and English. Prepare examples of how you've successfully navigated cross-cultural communications in previous roles, as this will be key to building trust with international partners.
✨Understand Regulatory Environments
Familiarise yourself with the regulatory frameworks in both China and the EU that impact clinical trials. Being able to discuss these regulations and how they affect trial operations will show your depth of knowledge and preparedness for the role.
✨Prepare for Operational Challenges
Think about potential operational challenges that could arise in global studies and how you would address them. Discussing your problem-solving strategies will demonstrate your proactive approach and readiness to lead operational meetings effectively.