Director, GCO Clinical Program Lead (GCPL)

BeOne Medicines USA; United States; Sur place; USD 140 000 - 210 000; Plein temps

Résumé du poste

BeOne Medicines USA is seeking an experienced Global Development Program Lead to drive strategic operational planning and clinical execution across designated programs. You will mentor global Clinical Study Managers, manage budgets and resources, and ensure timely delivery with high-quality standards in an international setting.

This role emphasizes cross-functional leadership, risk management, and alignment with BeOne’s R&D vision, enabling seamless partnerships and execution across time zones

Description du poste

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.

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 GC