Associate Director, Global Strategic Feasibility Lead

BeiGene

1d

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Global Strategic Feasibility Lead leads 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 Lead supports the Head of Global Strategic Feasibility to improve the Global Strategic Feasibility processes, procedures, and systems to strive for continuous optimization. Essential Functions of the Job: 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 Serves as the subject matter expert in feasibility tools, technologies, databases and platforms 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 Provide data-driven operational feasibility strategy, including country selection, patient and site allocation, site identification, and recruitment and retention recommendations at TA/indication/program level taking into consideration outstanding needs of indication, patient population, study, and business priorities Contributes in efforts to implement creative processes, methodologies, data, and technologies to ensure ongoing delivery of valued Global Strategic Feasibility service. Leads and contributes to Strategic planning meetings, training calls, kick off meetings and ongoing team meetings to ensure alignment of strategies and ongoing feasibility support. 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 Collaborates with Applied Innovations, Data Science & Operational Excellence, Clinical Systems & Innovation in the development of feasibility tools, systems and platforms Determines risk/ mitigation planning to study feasibility or recruitment and retention of the study participants. Maintains current therapeutic area knowledge and assesses impact of evolving information on operational strategies. Exhibits the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to study execution and patient enrollment and retention. Participates in global projects representing Global Clinical Operations and Global Strategic Feasibility team to support BeiGene 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 Computer Skills: Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g. Citeline, Studytrove, DRG, etc.) and additional feasibility software

Requirements

• Bachelor’s degree or higher in a scientific, medical or healthcare discipline with minimum of 5-7 years of combined experience in Feasibility, Clinical Trial Management, Personnel Management and Operations Management.
• Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g. Citeline, Studytrove, DRG, etc.) and additional feasibility software

Nice To Haves

• Experience with trial optimization vendors, tools, and methods.
• Proven experience in data analysis, data interpretation to drive inform decision making
• Proficiency with software models and database structures.
• Expertise in principles driving country/site identification, feasibility, and study startup strategies.
• Validated experience in data analysis, data interpretation to drive inform decision making
• Tried experience in managing, influencing, building, and managing relationships and achieving results with senior partners in conflicting priority environment
• Shown experience or willingness to learn how developing study delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives
• Clinical trial patient and investigator recruitment and retention experience
• Validated experience in project and budget management
• Confirmed global working experience

Responsibilities

• 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
• Serves as the subject matter expert in feasibility tools, technologies, databases and platforms
• 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
• Provide data-driven operational feasibility strategy, including country selection, patient and site allocation, site identification, and recruitment and retention recommendations at TA/indication/program level taking into consideration outstanding needs of indication, patient population, study, and business priorities
• Contributes in efforts to implement creative processes, methodologies, data, and technologies to ensure ongoing delivery of valued Global Strategic Feasibility service.
• Leads and contributes to Strategic planning meetings, training calls, kick off meetings and ongoing team meetings to ensure alignment of strategies and ongoing feasibility support.
• 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
• Collaborates with Applied Innovations, Data Science & Operational Excellence, Clinical Systems & Innovation in the development of feasibility tools, systems and platforms
• Determines risk/ mitigation planning to study feasibility or recruitment and retention of the study participants.
• Maintains current therapeutic area knowledge and assesses impact of evolving information on operational strategies.
• Exhibits the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to study execution and patient enrollment and retention.
• Participates in global projects representing Global Clinical Operations and Global Strategic Feasibility team to support BeiGene R&D goals.
• Support training and development of feasibility team members
• Drives high level of ownership and accountability within team and with external stakeholders

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director