Sr. Director, Clinical Operations, Europe
Sr. Director, Clinical Operations, Europe

Sr. Director, Clinical Operations, Europe

Abingdon Full-Time 72000 - 108000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead and manage Phase 3 global oncology clinical trials in collaboration with a Chinese partner.
  • Company: Join Summit Therapeutics, a pioneering biotech firm focused on innovative cancer therapies.
  • Benefits: Enjoy flexible working options, competitive salary, and opportunities for professional growth.
  • Why this job: Be at the forefront of groundbreaking cancer research while collaborating across cultures.
  • Qualifications: 10+ years in clinical operations, fluent in Mandarin and English, strong project management skills.
  • Other info: Potential travel to China and EU for collaboration and oversight.

The predicted salary is between 72000 - 108000 £ per year.

Career Opportunities with Summit Therapeutics Sub, Inc. A great place to work. Current job opportunities are posted here as they become available.

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.

Sr. Director, Clinical Operations, Europe employer: Summit Therapeutics Sub, Inc.

Summit Therapeutics Sub, Inc. is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the dynamic field of oncology clinical trials. With a strong emphasis on employee growth and development, team members are encouraged to thrive in a supportive environment that values diversity and cross-cultural collaboration, especially between Europe and China. The company offers competitive benefits and unique opportunities to be at the forefront of groundbreaking research, making it an ideal place for professionals seeking meaningful and impactful careers.
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Contact Detail:

Summit Therapeutics Sub, 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 China, especially regarding oncology. Understanding local regulations and cultural nuances will help you stand out as a candidate who can effectively bridge the gap between European and Chinese operations.

✨Tip Number 2

Network with professionals who have experience in managing clinical trials in China. Attend industry conferences or webinars focused on global clinical operations to gain insights and make connections that could be beneficial for your application.

✨Tip Number 3

Demonstrate your fluency in Mandarin by engaging in conversations or discussions related to clinical operations. This could be through online forums or local meetups, showcasing your ability to communicate effectively with potential partners.

✨Tip Number 4

Highlight any previous experience you have in cross-cultural collaboration, particularly in the pharmaceutical or biotechnology sectors. Providing examples of how you've successfully navigated different business cultures will strengthen your application.

We think you need these skills to ace Sr. Director, Clinical Operations, Europe

Fluency in Mandarin Chinese and English
Extensive experience in clinical operations
Strong understanding of Phase 3 clinical trial processes
Proven project management skills
Excellent communication and negotiation skills
Ability to manage timelines and deliverables
Experience in cross-cultural collaboration
Knowledge of Chinese and EU regulations for clinical trials
Strong problem-solving abilities
Organisational and time management skills
Proficiency in Microsoft Office Suite
Cultural competence in Chinese business practices
Experience in managing global oncology clinical trials
Ability to work independently and within a matrixed environment

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in clinical operations, particularly in Phase 3 oncology trials. Emphasise your fluency in Mandarin and English, as well as any experience working with international partners.

Craft a Compelling Cover Letter: In your cover letter, explain why you are the perfect fit for the role. Discuss your understanding of the operational aspects of clinical trials in China and Europe, and how your skills align with the responsibilities outlined in the job description.

Showcase Communication Skills: Since this role requires exceptional communication skills, provide examples in your application of how you've successfully collaborated with external partners, especially in cross-cultural settings. Highlight any specific instances where you navigated challenges effectively.

Highlight Problem-Solving Abilities: Demonstrate your problem-solving skills by including examples of how you've addressed operational challenges in previous roles. This could involve managing timelines or overcoming obstacles in clinical trial operations.

How to prepare for a job interview at Summit Therapeutics Sub, Inc.

✨Showcase Your Clinical Operations Expertise

Make sure to highlight your extensive experience in clinical operations, particularly with Phase 3 oncology trials. Be prepared to discuss specific projects you've managed and the outcomes achieved, as this will demonstrate your capability to handle the responsibilities of the role.

✨Demonstrate Cross-Cultural Communication Skills

Since the role involves collaboration with a Chinese partner company, it's crucial to showcase your fluency in Mandarin and English. Share examples of how you've successfully navigated cross-cultural business environments in the past, as this will be key to building rapport and trust.

✨Prepare for Scenario-Based Questions

Expect questions that assess your problem-solving skills and ability to manage timelines. Prepare scenarios where you faced operational challenges in clinical trials and explain how you addressed them, focusing on collaboration and communication with partners.

✨Understand the Company and Its Products

Familiarise yourself with Summit Therapeutics and their investigational therapies, especially ivonescimab. Being knowledgeable about their clinical trials and the competitive landscape will show your genuine interest in the company and the role.

Sr. Director, Clinical Operations, Europe
Summit Therapeutics Sub, Inc.

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