Study Start-Up

OverviewJoin to apply for the Study Start-Up / Site Activation Lead (Associate Director) role at Astellas Pharma.About AstellasAt Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on areas of greatest potential and 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 guide 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. We collaborate with regulatory authorities and payers to ensure access to new therapies and deliver insights and real-world evidence to inform decisions for patients and caregivers. We support stakeholder communities to drive initiatives that improve awareness, education, access and standards of care.The OpportunityAs a Study Start-Up / Site Activation Lead you will be responsible for the direct management of assigned study start-up related staff across all clinical trial types, including pre/post-POC interventional drug trials, Clinical Pharmacology healthy volunteer trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).You will identify, onboard, train, and develop study start-up talent to support planning, initiation and execution of clinical trials with a focus on operational excellence. You will provide leadership and mentorship within a matrix environment to support clinical trial teams. You will contribute to departmental budgeting and resourcing strategies, help shape global processes and procedures, support non-drug product initiatives, and coach staff during development trials. This role sits within Clinical Operations Excellence (COE) and reports into the Head, Study Start-up. This position is based in the UK. Candidates from Spain, Germany and Italy are welcome to apply.Hybrid Working – Astellas supports a flexible model with balance between home and office.Key ResponsibilitiesProviding oversight and guidance in completing study start-up activities according to timelines and quality standards, including identifying areas for additional training and development.Leading and managing study start-up teams, including recruitment, resource planning, mentoring, performance monitoring, and retention of staff; providing functional leadership globally.Ensuring operational excellence, overseeing adherence to timelines, standards, and processes, and serving as a point of escalation for start-up issues.Driving staff development, providing leadership and learning opportunities, ensuring training requirements are met.Collaborating cross-functionally to support process improvements, align on best practices, and contribute to the development of start-up standards and tools.Essential Knowledge & ExperienceExtensive study start-up activities and direct people management experience.Demonstrated leadership and ability to collaborate with Clinical Operations and cross-functionally to deliver portfolio deliverables and objectives.Strong knowledge of clinical development processes and conducting global clinical programs.Significant experience executing global drug development programs and trials.Extensive expertise in study start-up strategies with strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations.Experience across multiple phases of development and in multiple therapeutic areas.EducationBA/BS degree in life science or equivalent.Additional InformationThis is a permanent full-time position.This position is based in the United Kingdom.Hybrid working model; requires a blend of home and a minimum of 1 day per quarter in the local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.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. #J-18808-Ljbffr