Feasibility Lead

As a Feasibility Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• 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
• 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.

You are:

• BA/BS degree with at least 8 years of executing global drug development programs and trials
• 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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

#LI-Remote