Global Feasibility Head, Director
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
As the Country and Site Feasibility Head (Director), you will lead the strategic evaluation of regional suitability for clinical trials, leveraging both internal and external data to validate assumptions. Your role will involve developing and managing the systems and processes required to identify and recommend optimal countries, sites, and investigators to enhance trial performance.
You will be responsible for delivering the study-specific Country and Site Feasibility strategy, ensuring alignment with trial objectives, the Astellas portfolio strategy, and the company’s core country footprint. Additionally, you will oversee the Country and Site Feasibility Team, including project resourcing, functional metrics, and achieving annual objectives in collaboration with the SSU Head and Astellas senior leadership.
This role forms a part of the Development Clinical Operations team and reports into the Head, Site Activation & Business Management.
This position can be based in UK, France, Italy, Germany, Poland or Spain. Candidates interested in remote work are encouraged to apply.
Key Responsibilities:
- Building 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, enrolment scenarios, and enrolment optimisation strategies.
- Managing the Country and Site Feasibility Team as it relates to training, mentoring and performance. Implementing processes related to country and 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)
- Ensuring 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 enrolment assumptions, resource availability and engagement with Astellas local teams to inform study team recommendations for country selection
- Working closely with project delivery and local operations teams to continue to evolve detail on country footprint, enrolment assumptions, and appropriate site segmentation strategy to optimise trial delivery as the protocol elements evolve to final protocol and start up stages.
- Supporting 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.
Essential Knowledge & Experience:
- Demonstrable knowledge of analytical output and scenario planning to develop the Country and Site Feasibility strategy including reviews with appropriate study team members, to provide strategic input into team decision making
- Proven leadership skills
- Extensive experience and an excellent understanding of country and site feasibility for global trials using intelligence and other Real World Data sources
- Experienced in mining, reviewing, dissecting and interpreting 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.
- Developed clinical site relationships and data analysis to predict site performance
- Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives.
Preferred Experience:
- 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.
- Demonstrated ability to successfully identify and lead global process or system improvement initiatives.
Education/Qualifications:
- Bachelor’s degree in Health-Related Sciences or Business/Management or equivalent.
Additional Information:
- This is a permanent full-time position.
- This position can be based in UK, France, Italy, Germany, Poland or Spain.
- This position is 100% home / remote.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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