BeOne Medicines
Associate Director, Global Strategic Feasibility Analytics
BeOne Medicines, San Mateo, California, United States, 94409
General Description:
The Global Strategic Feasibility Analytics Lead plays a pivotal role in advancing our feasibility data analytics initiatives, serving as the subject matter expert (SME) in the development of robust feasibility tools and roadmaps. This position is responsible for transforming complex data into actionable insights that drive strategic feasibility decisions, enhance country and site feasibility, and optimize study planning. As the analytics lead, this role focuses on identifying innovative digital solutions and applying emerging technologies to bolster the team's analytical capabilities. By leveraging expertise in data analytics and systems, the Global Strategic Feasibility Analytics Lead collaborates with clinical development and clinical operations stakeholders to foster a culture of data-driven operations and informed decision-making.
In addition, the Global Strategic Feasibility Analytics Lead can on occasion lead the development of Global Strategic Feasibility proposals together with the regional strategic feasibility teams. Close partnership with global program & study management team for design and delivery of the studies, for early to late-stage medicines development across global clinical operations (GCO). Good understanding of global, regional, and country landscape and regulatory requirements. Drive high-quality strategic feasibility/site identification assessments based on Standard of Care, disease landscape and competitive intelligence including but not limited to competing trials, recent or upcoming approvals, prescribing data, insurance claims data, diversity, and recruitment capabilities. This includes intelligence gathering and risk assessment with therapeutic knowledge balanced with data analytics and interpretation.
The Global Strategic Feasibility Analytics Lead supports the Head of Global Strategic Feasibility to improve the Global Strategic Feasibility processes, procedures, capabilities and systems to strive for continuous optimization.
Essential Functions of the job:
Sets the
feasibility data analytics strategy and capabilities roadmap
.
Acts as key point of contact and subject matter expert in feasibility tools, technologies, databases and platforms.
Provides Global Clinical Operations (GCO) and Clinical Development stakeholders with forward-looking analyses, predictive models, and feasibility risk assessments to inform governance and program/study planning.
Plays a key role in driving the implementation of innovative processes related to data and technology, ensuring the continuous delivery of high-value Global Strategic Feasibility services.
Collaborates significantly with Applied Innovations, Data Science & Operational Excellence, Clinical Systems & Innovation in the development of
feasibility tools, systems and platforms
Collaborates with Data Science teams to
leverage advanced analytics, machine learning, and artificial intelligence techniques
for identifying trends, patterns, and opportunities within complex datasets, effectively applying these insights to tackle feasibility-related challenges.
On occasions, serves as the primary
point of contact for the Global Strategic Feasibility team and liaises cross-functionally to enable Global Strategic Feasibility proposal delivery
Ensures standardization in use of data, tools and process across regions to advise quality decision making at TA, indication, program and study levels
Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core team etc.; combines and integrates data to provide clear feasibility recommendations to strengthen data-driven trend analysis, identify root causes, and provide relevant recommendations across study teams and programs to accelerate study execution.
Partners with global clinical program leaders and development core team on study design optimization
Support modelling of strategy options for the study using relevant internal and external data assets, predictive models
Support interpretation of data and development of recommendations on operational strategy
Leads and/or contributes to Strategic planning meetings, training calls, kick off meetings and ongoing team meetings to ensure alignment of strategies and ongoing feasibility support.
Determines risk/ mitigation planning to study feasibility or recruitment and retention of the study participants.
Exhibits the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to study execution and patient enrollment and retention.
Supports the Head of Global Strategic Feasibility to develop global processes and procedures and coordinates with regions to ensure standardization and consistency
Supports Global Strategic Feasibility related initiatives and taskforces for continuous improvement and optimization.
Participates in global projects representing Global Clinical Operations and Global Strategic Feasibility team to support BeOne Medicines R&D goals.
Supervisory Responsibilities:
Support training and development of feasibility team members
Drives high level of ownership and accountability within team and with external stakeholders
Education Required:
Bachelor's degree or higher in a scientific, medical or healthcare discipline* with minimum of 8 years of combined experience in Feasibility, Clinical Data Analytics, Clinical Trial Management, and Operations Management.
*Exceptions may be made for candidates with appropriate Clinical Operations experience
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.
The Global Strategic Feasibility Analytics Lead plays a pivotal role in advancing our feasibility data analytics initiatives, serving as the subject matter expert (SME) in the development of robust feasibility tools and roadmaps. This position is responsible for transforming complex data into actionable insights that drive strategic feasibility decisions, enhance country and site feasibility, and optimize study planning. As the analytics lead, this role focuses on identifying innovative digital solutions and applying emerging technologies to bolster the team's analytical capabilities. By leveraging expertise in data analytics and systems, the Global Strategic Feasibility Analytics Lead collaborates with clinical development and clinical operations stakeholders to foster a culture of data-driven operations and informed decision-making.
In addition, the Global Strategic Feasibility Analytics Lead can on occasion lead the development of Global Strategic Feasibility proposals together with the regional strategic feasibility teams. Close partnership with global program & study management team for design and delivery of the studies, for early to late-stage medicines development across global clinical operations (GCO). Good understanding of global, regional, and country landscape and regulatory requirements. Drive high-quality strategic feasibility/site identification assessments based on Standard of Care, disease landscape and competitive intelligence including but not limited to competing trials, recent or upcoming approvals, prescribing data, insurance claims data, diversity, and recruitment capabilities. This includes intelligence gathering and risk assessment with therapeutic knowledge balanced with data analytics and interpretation.
The Global Strategic Feasibility Analytics Lead supports the Head of Global Strategic Feasibility to improve the Global Strategic Feasibility processes, procedures, capabilities and systems to strive for continuous optimization.
Essential Functions of the job:
Sets the
feasibility data analytics strategy and capabilities roadmap
.
Acts as key point of contact and subject matter expert in feasibility tools, technologies, databases and platforms.
Provides Global Clinical Operations (GCO) and Clinical Development stakeholders with forward-looking analyses, predictive models, and feasibility risk assessments to inform governance and program/study planning.
Plays a key role in driving the implementation of innovative processes related to data and technology, ensuring the continuous delivery of high-value Global Strategic Feasibility services.
Collaborates significantly with Applied Innovations, Data Science & Operational Excellence, Clinical Systems & Innovation in the development of
feasibility tools, systems and platforms
Collaborates with Data Science teams to
leverage advanced analytics, machine learning, and artificial intelligence techniques
for identifying trends, patterns, and opportunities within complex datasets, effectively applying these insights to tackle feasibility-related challenges.
On occasions, serves as the primary
point of contact for the Global Strategic Feasibility team and liaises cross-functionally to enable Global Strategic Feasibility proposal delivery
Ensures standardization in use of data, tools and process across regions to advise quality decision making at TA, indication, program and study levels
Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core team etc.; combines and integrates data to provide clear feasibility recommendations to strengthen data-driven trend analysis, identify root causes, and provide relevant recommendations across study teams and programs to accelerate study execution.
Partners with global clinical program leaders and development core team on study design optimization
Support modelling of strategy options for the study using relevant internal and external data assets, predictive models
Support interpretation of data and development of recommendations on operational strategy
Leads and/or contributes to Strategic planning meetings, training calls, kick off meetings and ongoing team meetings to ensure alignment of strategies and ongoing feasibility support.
Determines risk/ mitigation planning to study feasibility or recruitment and retention of the study participants.
Exhibits the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to study execution and patient enrollment and retention.
Supports the Head of Global Strategic Feasibility to develop global processes and procedures and coordinates with regions to ensure standardization and consistency
Supports Global Strategic Feasibility related initiatives and taskforces for continuous improvement and optimization.
Participates in global projects representing Global Clinical Operations and Global Strategic Feasibility team to support BeOne Medicines R&D goals.
Supervisory Responsibilities:
Support training and development of feasibility team members
Drives high level of ownership and accountability within team and with external stakeholders
Education Required:
Bachelor's degree or higher in a scientific, medical or healthcare discipline* with minimum of 8 years of combined experience in Feasibility, Clinical Data Analytics, Clinical Trial Management, and Operations Management.
*Exceptions may be made for candidates with appropriate Clinical Operations experience
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.