Associate Director, Regional Clinical Study Management

About us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description:

General Description:

• Provides leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio
• Collaborate with cross-functional teams to establish advanced planning strategies of new trials and ensure the efficient execution of clinical trials in Japan.
• Contributes to resourcing and capability development related to regional study management
• Ensures alignment of regional resources and deliverables with overall portfolio goals
• Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations’ function to drive faster, high quality clinical trials
• Provide expert knowledge on the execution of clinical trials, expert understanding of ICH/GCP Guidelines and other applicable regulatory requirements
• English - Japanese translation of study document amendments during CTN review

Essential Functions of the job:

• Lead the development and implementation of clinical trial strategies in Japan, ensuring alignment with corporate goals and Japan objectives.
• Drive operational efficiency by optimizing process, leveraging digital innovations, and ensuring risk mitigation strategies are in place.
• Ensure that clinical trials are conducted with high quality, adhering to regulatory requirements and GCP while maintaining cost-effectiveness and speed.
• Build and lead a high-performing Clinical Operations team in Japan by recruiting top-tier talent, ensuring a structured onboarding process, and providing continuous professional development opportunities.
• Establish and improve Japan specific Work Instruction, SOPs (if any) and processes.
• Enhance site engagement to eliminate non or low enrolment sites and complete Japan country level patient enrolments on time.
• Collaborate with cross-functional teams to establish advanced planning strategies of new trials and ensure the efficient execution of clinical trials in Japan.
• Implementing robust processes to uphold trial quality from initiation through completion.
• Maintaining inspection ready for all eTMFs throughout the lifecycle of every trial.
• Ensuring that all clinical operations teams, investigators, and site personnel are well-trained on inspection readiness, document management, and all relevant trial materials to confidently navigate inspections when they occur.
• Contributes to and has accountability for overall Clinical Operations strategy and performance against key metrics
• Actively oversees the knowledge management process by ensuring information is captured, retained, and leveraged for future work
• Ensures operational processes, systems and standards are adopted and implemented consistently across trials
• Champions a global mindset and approach across Clinical Operations to foster increased collaboration and consistency across BeOne
• Ensures alignment with broader BeOne strategic initiatives and business needs and provides recommendations or ideas on how Clinical Operations’ programs can generate greater value for BeOne overall
• Ensures Clinical Operations thinking, and activities are aligned with overall business direction and priorities 
• Identifies opportunities and initiatives within the broader organization that can be adopted/adapted by Clinical Operations as best practice; equally recommends best practices within Clinical Operations that if more broadly applied would benefit BeOne as a whole
• Maintains a working knowledge of, and assures compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and SOPs
• Implements and revises SOPs and monitors departmental compliance
• Participates in formal staff performance review processes
• Escalates issues to BeOne Senior Management team timely
• Demonstrates strong initiative in activities through the clinical trials and other company initiatives
• Proactively identifies potential issues and seeks improvement.  
• Takes initiative for issue resolution within and outside the Clinical Operations department.
• Coordinates the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans
• Responsible for building and developing the Clinical Operation organization, including the hiring, training, development and resource allocation of BeOne and oversight FSP.

Supervisory Responsibilities:  

• Line Management of direct reports

Qualification Required:

Education & Experience Required:  

Bachelor or higher degrees (life science preferred, including medicine, nursing, biology and laboratory technology) and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.

Computer Skills: Efficient in Microsoft Word, Excel, and Outlook

Other Qualifications:    

• Fluent in English
• Excellent organizational skills and ability to prioritize and multi-task
• 13 years or above in clinical or drug development in the biotech/pharmaceutical/CRO industry or the relevant clinical research field
• Minimum of 8 years of project management and/or clinical monitoring/ or startup experience (AD)

Travel: be flexible based on business needs

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme

• Company shares (generous welcome grant!)

• In-house and external learning and development opportunities

• Fantastic benefits program and keep improving!

• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

• Join us and Make momentum in your career!

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.