Director, GCO Clinical Program Lead (GCPL)

About the role

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 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). 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.

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

Responsibilities

• Accountable and responsible for building, developing, and retaining the global team of Global Clinical Study Managers (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 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.
• 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.
• In coordination with Franchise Head, accountable to the Franchise ERC, DCT, and other governance teams 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.
• 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.
• Champion 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.
• Collaborate with cross-functional leaders to provide operational perspectives to enable effective and efficient delivery of clinical development goals.

Requirements

• Bachelor or higher degree in a scientific or healthcare discipline with 10+ years’ experience in the clinical trial industry.
• 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.
• Proficiency in MS Office, Project Planning Applications, and Clinical Trial Management Systems (CTMS).
• Ability to travel domestically and internationally up to 20%.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, 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

Supervisory Responsibilities

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

Pay

Salary Range: $171,900.00 - $231,900.00 annually.

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.

Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.

Benefits

• Medical, Dental, Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness programs