Global Feasibility Lead Associate Director
Global Feasibility Lead Associate Director
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Job Description
Job Title: Global Feasibility Lead Associate Director
Job Location: England UK
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Director
Global Feasibility Lead Associate 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 underserved disease areas and in lifethreatening or lifelimiting 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 patientcentric 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 realworld evidence to inform the best decisions for patients and their caregivers 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 Global Feasibility Lead you will be responsible for the strategic evaluation of a region's suitability for a clinical trial using external and internal data sources to validate assumptions. Here you will recommend the right countries sites and investigators for a trial to optimize trial performance.
You will deliver the studyspecific Country and Site Feasibility strategy for each study in alignment with the trial objectives Astellas portfolio strategy and the Astellas core country footprint.
Your role forms a part of the Development Clinical Operations team and reports into the Business Strategy Lead Clinical Compliance Clinical Standards & Systems.
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.
- 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 startup 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 startup 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 coordinating 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 decisionmaking.
- 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 sitereported data and systems in various formats to apply to individual assessments drive multifunctional 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 crossfunctionally to deliver on portfolio deliverables and objectives.
Preferred Experience:
- 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.
- Proven leadership skills and effective written and verbal communication skills.
Education/Qualifications:
- Bachelor’s Degree in HealthRelated Sciences or Business/Management or equivalent.
Additional Information:
- This is a permanent fulltime 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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Employment Type
Full Time
