Job Information
BeOne Medicines Director, GCO Clinical Program Lead (GCPL) – Early Phase in San Mateo, California
General Description:
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 Early Phase programs and acts as a point of escalation for the resolution of issues of the studies within responsible program(s).
Provide strategic leadership to gCSMs 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.
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 Early Phase 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 managing direct reports of Global Clinical Study Managers (GCSMs)
Computer Skills: Microsoft Office, Project Planning Applications, Clinical Trial Management Systems
Other Qualifications:
Proven project and program management experience in Early Phase clinical trials; First-In-Human experience favored.
Proven pProject management exposure/experience across the entire lifecycle of multi-region/country clinical trials in a fast-paced global environment.
Oncology experience preferred
Experience in both people management and program management preferred.
Travel: Travel might be required as per business need.
Education Required:
Bachelor or higher degree in a scientific or healthcare discipline with 10+ years’ progressive experience in clinical trial industry.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.