Associate Director, Regional Clinical Study Management

BeOne Medicines; Kuala Lumpur; On-site; MYR 300,000 - 460,000; Full time

Benefits offered by this job

Company shares

Learning & development opportunities

Job summary

BeOne Medicines in Malaysia seeks an Associate Director, Regional Clinical Study Management (SEA) to lead regional trial strategies and a high-performing team across Southeast Asia. You will align portfolio delivery with Global Clinical Operations goals, ensuring timelines, budgets, and quality are met.

In this role, you will partner with cross-functional teams, oversee FSPs, and drive continuous improvement while maintaining compliance with ICH-GCP standards and regulatory requirements.

Qualifications

• Bachelor or higher degree in life sciences or related field; 8+ years in clinical operations.
• Proven leadership of regional clinical study teams and vendors.
• Strong knowledge of ICH-GCP and global trial processes.

Responsibilities

• Provide portfolio oversight and governance for Southeast Asia regional trials.
• Lead, coach, and develop BeOne and FSP regional study managers.
• Ensure studies are delivered on time, within budget, and compliant with protocols.

Skills

Regional leadership

Clinical study management

Cross-functional leadership

Education

Bachelor or higher degree (life science preferred)

Tools

CTMS

EDC

eTMF

Job description

About Us

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: The Associate Director, Regional Clinical Study Management (SEA) provides strategic and operational leadership for the Regional Clinical Study Management (rCSM) function across Southeast Asia. The role is accountable for leading, developing, and managing a high-performing team of BeOne and Functional Service Provider (FSP) Regional Clinical Study Managers to ensure the successful planning, execution, and delivery of the regional clinical trial portfolio in alignment with Global Clinical Operations strategy and business objectives.

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).

Job Description

General Description: Working in close partnership with Country Heads, Global Study Teams, Clinical Development, and other cross-functional stakeholders, the Associate Director provides portfolio oversight, study governance, resource planning, risk management, and operational leadership to ensure studies are delivered on time, within budget, and in compliance with study protocols, ICH-GCP, applicable regulatory requirements, and company quality standards. The role also partners with Country Clinical Operations to support strategic site engagement and resolve complex operational challenges that impact study delivery. The Associate Director is responsible for building organizational capability within the Regional Clinical Study Management function through workforce planning, talent acquisition, performance management, coaching, mentoring, succession planning, and oversight of FSP partnerships, fostering a culture of accountability, collaboration, innovation, and continuous improvement. As the functional leader for Regional Clinical Study Managers across Southeast Asia, the Associate Director represents the region in global governance and strategic planning discussions, contributes to the development of Clinical Operations strategies and best practices, and drives operational excellence to support BeOne's expanding clinical development portfolio.

Essential Functions Of The Job

• Lead the Regional Clinical Study Management (rCSM) function across Southeast Asia, providing strategic direction, operational oversight, and people leadership for BeOne Regional Clinical Study Managers, while providing functional leadership and oversight for Functional Service Provider (FSP) Regional Clinical Study Managers to ensure successful delivery of the regional clinical trial portfolio.
• Develop and implement Regional Clinical Study Management strategies aligned with Global Clinical Operations objectives, corporate priorities, and Southeast Asia business goals.
• Build, lead, and develop a high-performing team of BeOne Regional Clinical Study Managers (rCSMs) through workforce planning, recruitment, onboarding, coaching, performance management, succession planning, and continuous professional development. Provide functional leadership, onboarding support, and capability development for Functional Service Provider (FSP) Regional Clinical Study Managers in partnership with the vendor.
• Provide functional leadership to BeOne and Functional Service Provider (FSP) Regional Clinical Study Managers, ensuring effective study planning, execution, risk management, budget oversight, and delivery of assigned regional clinical studies.
• Establish regional study governance to oversee portfolio performance, monitor key milestones, timelines, quality, budgets, resources, and operational metrics, ensuring timely escalation and resolution of critical issues.
• Ensure clinical studies are executed in accordance with study protocols, ICH-GCP, applicable regulatory requirements, company SOPs, and quality standards while maintaining cost-effectiveness and delivery timelines.
• Drive operational excellence by optimizing Regional Clinical Study Management processes, leveraging digital innovation, implementing standardized best practices, and fostering a culture of continuous improvement.
• Establish, implement, and continuously improve Southeast Asia-specific Work Instructions, SOPs (where applicable), governance processes, and operational standards to enhance consistency, quality, compliance, and efficiency.
• Partner with Country Heads, Global Study Teams, Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Clinical Supply, and other cross-functional stakeholders to ensure effective planning, execution, and delivery of regional clinical studies.
• Provide matrix leadership across Regional Clinical Study Managers, Country Clinical Operations, and Global Study Teams to ensure aligned study execution, effective communication, and achievement of study objectives.
• Partner with Country Heads and Regional Clinical Study Managers to develop and execute site engagement and enrollment strategies. Engage directly with key investigators, strategic sites, and underperforming sites, when appropriate, to resolve operational challenges, improve enrollment, and support successful study delivery.
• Lead the regional study risk management process by proactively identifying operational risks, evaluating potential impact, implementing mitigation strategies, and ensuring timely escalation of significant issues to senior management.
• Ensure robust quality management processes are implemented throughout the study lifecycle and maintain inspection readiness for Trial Master Files (TMFs/eTMFs) across the regional study portfolio.
• Ensure BeOne and Functional Service Provider (FSP) Regional Clinical Study Managers maintain expertise in study governance, inspection readiness, document management, and applicable regulatory requirements to support successful inspections and audits.
• Partner with Functional Service Provider (FSP) management to support resource planning, onboarding, performance feedback, capability development, and continuous improvement, ensuring FSP Regional Clinical Study Managers consistently meet BeOne quality and operational expectations.
• Contribute to and be accountable for Regional Clinical Operations performance against key business, operational, and quality metrics, driving continuous improvement across the Regional Clinical Study Management function.
• Champion knowledge management by ensuring lessons learned, operational insights, and best practices are captured, shared, and leveraged to improve future study execution across the region.
• Ensure Regional Clinical Study Management processes, systems, governance, and performance standards are consistently adopted and implemented across all assigned studies.
• Identify and implement innovative approaches and industry best practices to improve study delivery, operational efficiency, and organizational effectiveness, while contributing ideas that generate broader value for BeOne.
• Ensure Regional Clinical Study Management initiatives remain aligned with BeOne's overall business strategy and Global Clinical Operations priorities.
• Maintain expert knowledge of ICH Guidelines, Good Clinical Practice (GCP), applicable regulatory requirements, company SOPs, and industry standards, ensuring departmental compliance through effective leadership and oversight.
• Participate in formal performance management, coaching, mentoring, and career development activities for BeOne Regional Clinical Study Managers, while providing ongoing functional coaching and performance feedback for Functional Service Provider (FSP) Regional Clinical Study Managers through vendor governance processes.
• Demonstrate strong leadership by proactively identifying operational challenges, driving issue resolution, fostering collaboration across functions, and promoting a culture of accountability, quality, and continuous improvement.
• Represent Southeast Asia Regional Clinical Study Management in global governance forums, portfolio reviews, and strategic planning discussions, as appropriate, ensuring regional perspectives are incorporated into global study planning and execution

Supervisory Responsibilities

• Line Management of direct reports

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

• Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, Teams, and other business applications.
• Proficient in project management tools and methodologies, including Gantt chart development, project scheduling, resource planning, milestone tracking, and risk management.
• Working knowledge of Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), electronic Trial Master File (eTMF) systems, and other clinical trial technologies.
• Ability to utilize project management dashboards, operational metrics, reporting tools, and clinical trial systems to support portfolio oversight, decision-making, resource planning, and performance management.

Other Qualifications

• Fluent in written and spoken English.
• Excellent organizational, planning, prioritization, and multitasking skills, with the ability to manage multiple competing priorities in a fast-paced, matrix environment.
• Minimum of 13 years of experience in clinical research, clinical development, or drug development within the biotechnology, pharmaceutical, CRO, or related healthcare industry.
• Minimum of 8 years of clinical project management and/or Regional Clinical Study Management experience, with demonstrated responsibility for leading regional or global clinical trials.
• Minimum of 3–5 years of people management experience, including leading and developing high-performing teams.
• Demonstrated experience managing cross-functional teams and influencing stakeholders within a matrix organization.
• Experience providing functional leadership and oversight of Functional Service Provider (FSP) resources is preferred.
• Strong knowledge of ICH-GCP, applicable regulatory requirements, and global clinical trial processes.
• Experience leading oncology and/or hematology clinical trials is preferred.
• Experience managing multi-country clinical trials across Southeast Asia or other regions is preferred.
• Project Management Professional (PMP) certification or equivalent project management certification is preferred.

Travel

Willingness to travel domestically and internationally, as required to support 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

• 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.