Country and Site Feasibility Lead

Description

• The Country and Site Feasibility Lead is responsible to build evidence driven by study assumptions to provide a country and site strategy that includes a list of proposed countries and sites to be targeted during site feasibility/selection, enrollment scenarios, and enrollment optimization strategies.
• Implementing processes related to country & site intelligence and provide continuity by connecting and documenting changes throughout the lifecycle (from early estimates, early feasibility, detailed assumptions, detailed feasibility, to participant recruitment, study start-up planning and last subject first visit)
• Provides early feasibility (before core protocol elements are available) by providing potential country footprint considering available intelligence sources (benchmark studies, competitive landscape, treatment approvals etc), key enrollment assumptions, resource availability and engagement with Astellas local teams to inform study team recommendations for country selection
• As protocol elements evolve to final protocol and start up stages, work with project delivery team and local operations teams to continue to evolve detail on country footprint, enrollment assumptions, and appropriate site segmentation strategy to optimize trial delivery
• Support the build of the investigator database, collection of information supporting the definition of the ideal site for a study, identification of suitable sites for a study, and coordinate global efforts for site intelligence
• Provide analytical output and scenario planning to develop the Country and Site Feasibility strategy including reviews with appropriate study team members, and provide strategic input into team decision making
• Expertly mine, review, dissect and interpret clinical trial business intelligence information, data analytics, site reported data and systems in various formats to apply to individual assessments, drive multi-functional discussion and derive recommendations related to protocol, country, accrual rate and site components of assigned assessments.
• Review of scientific literature and self-training pertinent to feasibility activities.
• Develop feasibility assessment questionnaires, input into survey tools, assess data and collate to develop meaningful metrics to drive recommendations and decisions.
• Analyze results of country and site outreach and evidence to build the recommended country and site strategy
• Evaluate performance of study deliverables against recommended countries and site performance to optimize future selection strategy’s. Partners with project delivery and SORD teams to improve overall study start up and recruitment cycle time metrics.
• Build relationships and engagement with local operational teams and clinical sites to proactively prepare for future studies in line with Astellas pipeline.
• Promote a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity through uptake of innovative strategies
• Maintain effective relationships with country teams, portfolio delivery teams and other business functions to support effective portfolio delivery.
• Engage with study start up team to ensure site level feasibility is completed in line with study site selection strategy. Trouble shoot any issues and resolve accordingly with input from the portfolio delivery teams.

Qualifications

• BA/BS degree with at least 8 years of executing global drug development programs and trials ; Advanced degree preferred
• Minimum of 4 years country and site feasibility experience for global trials using intelligence and other RWD sources
• Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives
• Must have extensive expertise in strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
• Must have experience working across multiple phases of development and in multiple therapeutic areas
• Demonstrated ability to successfully identify and lead global process or system improvement initiatives
• Must have demonstrated experience developing clinical site relationships and data analysis to predict site performance
• Must have proven leadership skills and effective written and verbal communication skills
• Fluent in English. Depending on hiring region, may also be required to be fluent in local language.
• Minimal (~10%) travel required