Country and Site Feasibility Lead at Astellas in Northbrook, Illinois

Job Description:

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Country and Site Feasibility Head is responsible for the development and oversight of the strategic evaluation of each region's suitability for a clinical trial using external and internal data sources to validate assumptions. The role will be responsible for the systems and processes leading to the recommendation of the right countries, sites, and investigators for a trial to optimize trial performance.

The Country and Site Feasibility Head will be accountable for the delivery of the study specific Country and Site Feasibility strategy for each study in alignment with the trial objectives, Astellas portfolio strategy and the Astellas core country footprint.

The Country and Site Feasibility Head will be responsible for the oversight of the Country and Site Feasibility Team, resourcing to each project, metrics related to the function and meeting the yearly objectives established in coordination with the SSU Head and Astellas senior leadership.

Essential Job Responsibilities:

• The Country and Site Feasibility Head is a people management role and is responsible for the management of the Country and Site Feasibility Team as it relates to training, mentoring and performance.


• The Country and Site Feasibility Head is responsible for the methods and process needed 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.


• Supporting the implementation of the 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)


• Supports 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.


• Strategically support the build of the investigator database, define the 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.


• Develop the analytical output and scenario planning to develop the Country and Site Feasibility strategy including reviews of feasibility performance with leadership teams to report on progress of studies and oversee continuous improvement efforts.


• 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 questionnaire templates, input into survey tools, assess data and collate to develop meaningful metrics to drive recommendations and decisions on a global scale.


• Analyze results of country and site outreach and evidence to guide team members in building the recommended country and site strategy.


• Evaluate performance of study deliverables against recommended countries and site performance to optimize future selection strategies. 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.


• Perform the role and tasks of the Country and Site Feasibility Lead as needed to ensure the timely completion of work.