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Job description
Leveraging deep Therapeutic Area/Asset expertise, solid global program management skills, global view, and borderless leadership, the GCO Franchise Head is accountable for the strategic operational planning and clinical operational performance to deliver in the Franchise(s)- therapeutic area(s) or asset(s), and acts as point of escalation for resolution of issues of the associated program(s) in the Hematology Franchise(s). The Franchise Head will lead and manage the Global Clinical Program Lead (GCPL)/ Global Clinical Study Manager (gCSM) group in designated Franchise(s)- therapeutic area (s) or asset(s), provides inspirational leadership, facilitate proactive risk and issue management, and provide feedback-oriented mentorship to the GCPLs/gCSMs reports, fostering talent development. As a member of the leadership team of GCO P&SM, participate in shaping P&SM strategy, lead the functional management activities, and apply strategic thinking across franchise(s)-therapeutic area(s) or asset(s) to influence long-term strategy, partner with other Franchise Heads/Functional Representatives in BeOne R&D, drive Therapeutic/Asset strategy and ensure execution excellence by contributing clinical operations insights and expertise at franchise level. The Senior Director may act as a leading representative and spokesperson from GCO for the assigned franchise(s)-therapeutic area(s) or asset(s), the functional area, and the company on matters of critical importance to the company.
Essential Functions of the job:
Strategic leadership and management
Accountable and responsible for building, developing and retaining the global team of GCPL/gCSM, including hiring, training, mentoring, developing direct and indirect reports, performance appraisals and resource management
Oversee the delivery and goal achievement of programs and projects within the designated Franchise(s)- therapeutic area(s) or asset(s), serving as the point of escalation for resolving issues that GCPLs cannot resolve
Collaborate with the other Franchise Heads to define and implement strategies and key priorities, and establish global standards for goals, key performance measures, and capability development for the GCPL/gCSM roles
As a member of the leadership team within GCO P&SM, participate in the decision making and strategy shaping in P&SM,, and collaborate with other P&SM LTs to lead functional management activities, process optimization initiatives, and streamline process across franchise(s)-therapeutic area(s) or asset(s)
GCO Representative for the designated Franchise(s)-therapeutic area(s) or asset(s)
Accountable to the Franchise ERC, DCT and other governance teams as appropriate as GCO representative, to provide clinical operational insight to drive the Therapeutic/Asset strategy, and ensure excellence in execution
Lead/participate in the KOL engagement activities in the designated franchise(s)- therapeutic area(s) or asset(s) 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 annual budget and resource forecasts, as well as relevant DCT goals for the program
Create, review, and provide input to maintain compound-level documents such as IB, DSUR and protocol
Provide guidance to the CST and ensure timely, quality, and efficient study planning and execution of associated clinical programs/studies
Conduct regular program review meetings to mentor, support, and ensure all studies within the program are tracking to budget and timeline
Report on program/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 direct reports
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 program -related issues
Identify and drive process improvement initiatives in collaboration with other Franchise Heads and GCPLs
Collaborates with cross-functional leaders to provide operational perspectives to enable effective and efficient delivery of clinical development goals
Supervisory Responsibilities:
Line managing direct or indirect reports
Education and Experience:
Bachelor or higher degree in a scientific or healthcare discipline with 12+ years’ experience in clinical trial industry
Both Project and Program management experience across the entire lifecycle of multi-region/country clinical trials in a fast paced global environment, with proven excellent record and accomplishments in related GCO areas and demonstrated good leadership capabilities/ potential
3+ years of leadership and people management experience is required, including 3+ years of leadership and people management experience at managing senior manager level above persons, and experience of 2nd line management preferred
3+ years experience in Hematology cancers preferred
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.
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Worksite address
san mateo, CA, 94409, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.