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: 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. 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.<