Shire Jobs

General 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 Franchise(s)

• 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 BeiGene R&D, drive Therapeutic/Asset strategy and ensure execution excellence by contributing clinical operations insights and expertise at franchise level

• 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

Education and Experience:

• Bachelor's degree 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

• 5+ 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

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.