Associate Director / Director, GCO Clinical Program Lead (GCPL)

General Description:

At BeOne, our Global Development SuperHighway — our integrated, end-to-end, wholly internal development capability — is a cornerstone of our R&D vision. It brings together a unique set of internal cross-functional capabilities from across the globe needed for efficient delivery of clinical trials to develop impactful medicines to accelerate access to innovation for patients around the world.

We are now opening this same delivery engine to the world’s most promising external science. Through SuperHighway partnerships, highly promising assets from leading biotech partners can access our development capabilities creating a true win-win ecosystem with the ultimate goal of helping more patients around the world. This is not a fee-for-service model; it is a bold new way to grow the company and expand what’s possible in oncology. This is a rare opportunity to help build something genuinely new — joining a high-caliber, agile team at the leading edge of clinical development innovation. If you are energized by building, by challenging the status quo, and by making a real impact on patients’ lives, this is where you belong.

Leveraging deep Therapeutic Area expertise, solid global program management skills, global view, and borderless leadership, the GCO Program Lead is accountable for the strategic operational planning and clinical operational performance, of designated programs and acts as a point of escalation for the resolution of issues of the studies within responsible program(s).

Provide strategic leadership to global Clinical Study Managers across designated programs by setting clear expectations, fostering a culture of accountability and proactive risk management, and ensuring alignment with organizational goals. Act as a mentor and coach to develop talent, drive performance excellence, and support career growth through regular feedback and development planning. Collaborate cross-functionally to enable program success and maintain high standards of delivery.

Partner with other program leads/functional representatives in BeOne R&D to drive disease/asset strategy and ensure execution excellence by contributing clinical operations insights and expertise at the program level.

This is an international role and requires working with colleagues in various time zones.

This role helps deliver the partnership studies that run on our Clinical SuperHighway, supporting seamless onboarding and high-quality execution of external partner projects in close partnership with the execution functions.

Essential Functions of the Job:Strategic leadership and management

• Accountable and responsible for building, developing and retaining the global team of gCSM, including hiring, training, mentoring, developing direct and indirect reports, performance appraisals and resource management.
• Oversee the delivery and goal achievement of projects within the designated program(s), serving as the point of escalation for resolving issues that gCSM cannot resolve.
• Collaborate with the other GCPLs and Franchise Heads (FH) to define and implement strategies and key priorities across-programs, and establish global standards for goals, performance measures, and capability development for the gCSM roles.

GCO Representative for the designated program(s)

• In coordination with Franchise Head, Accountable to the Franchise ERC, DCT and other governance teams as appropriate as GCO representative, to provide clinical operational insight to drive the program strategy and ensure excellence in execution.
• Lead/participate in the KOL engagement activities in the designated programs and may act as function spokesperson if needed.

Program Management

• Evaluate and develop strategic feasibility and budget estimates during Early Planning for new CDPs and upon strategy change during the conduct of a study, where needed.
• Accountable for resource allocation and initiating CST formation; ensures appropriate transition of outputs from early planning to the gCSM.
• Create and be accountable for the annual program budget and resource forecasts, as well as contributing to and tracking the relevant DCT goals for the program.
• Create, review, and provide input to and maintain compound-level documents such as IB, DSUR, and protocol.
• Oversee timely, quality, and efficient study planning and execution of associated studies within the allocated program.
• Conduct regular program review meetings to mentor, support, and ensure all studies are tracking to the DCT/DRC-approved budget and timeline.
• Report on study status, goals, and operational KPIs, and enforce quality KPIs with support from the Compliance team.
• Collaborate with other GCPLs to evaluate and designate preferred global vendors and participate in vendor governance meetings.
• Create or review performance and development plans for direct reports, facilitate and support delivery of performance and development goals.
• Provide line management and mentorship to gCSMs working within the designated program(s).
• Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations’ function.
• Champions a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization.
• Provide expert knowledge on the execution of clinical trials through a deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements.
• Point of escalation for all compound-related issues.
• Identify and drive process improvement initiatives in collaboration with Franchise Head and/or other GCPLs within program.
• Collaborates with cross-functional leaders to provide operational perspectives to enable effective and efficient delivery of clinical development goals.

Supervisory Responsibilities: Line-manages direct reports of Global Clinical Study Managers (gCSMs).

Education Required:

Bachelor or higher degree in a scientific or healthcare discipline with 10+ years’ experience in clinical trial industry.

Computer Skills: MS Office; Project Planning Applications; Clinical Trial Management Systems (CTMS)

Other Qualifications:

• Project management exposure/experience across the entire lifecycle of multi-region/country clinical trials in a fast-paced global environment. Experience in both people management and program management preferred.

Travel: Up to 20%. Ability to travel domestically and internationally.

百济神州全球胜任力
当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。
●团队协作
●提供并征求坦诚及可行的反馈
●自我认知
●兼容并蓄
●积极主动
●开拓精神
●持续学习
●拥抱变化
●结果导向
●分析性思维/数据分析
●卓越财务
●清晰沟通

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

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