Study Start-up Lead GB, KTNX

Study Start-up Lead (Addlestone, UK)

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

This is a permanent role based in Addlestone, UK. This position is hybrid with the expectation to be in office once per quarter.

Astellas’ Responsible Flexibility Guidelines Statement
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

This position is accountable for the direct management of assigned study start-up related staff across all clinical trial types, which may include pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).

Accountable for the identification, onboarding, training and development of study start-up talent to support the planning, initiation, and execution of clinical trials with operational excellence. Individuals in this role will also provide leadership/mentorship, in a matrix setting, for activities that support clinical trial teams.

This position is accountable to the Head, Study Start-up, and will provide input into departmental budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and coaching of staff during execution of development trials.

This position provides functional leadership and management globally of

• Responsible for resource planning, recruitment, mentoring, development and retention of study start-up staff.
• Manages and allocates study start-up resources to trials and monitor performance on assigned trials for staff (up to 12 direct reports).
• Provides direction, leadership and learning opportunities to enhance individual development of direct reports.
• Provides oversight and guidance in completing study start-up related activities according to agreed timelines and quality standards, including identifying areas for additional training and development.
• Oversees adherence to timelines, standards, processes for work assigned to their staff.
• Serves as a point of escalation for study start-up related topics or issues from their staff.
• Responsible for compliance of direct reports with training and identification and support for any training needs.
• Facilitates and supports global trial study start-up operational standards and tools.
• Anticipates, recognizes and facilitates problem solving to support staff and rapidly addresses and mitigates potential performance issues.
• Collaborates effectively with Portfolio Operations Leads and Clinical Operations Leads, to ensure study start up staff are delivering as expected and to ensure common framework and…