Clinical Operations Lead (Director) - Oncology in Addlestone

At Astellas, we are making treatments that matter to people. We are tackling the toughest health challenges, putting the patient at the heart of every move we make. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. 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 have developed ground-breaking, innovative medicines in immunology, oncology, and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible, and improving the quality of life for those living with conditions where needs are often overlooked.

The Opportunity: As a Clinical Operations Lead (Director) at Astellas Pharma, you will play a pivotal role in overseeing the strategic input and operational insights into the asset development planning lifecycle. Your contributions will directly impact the development of innovative therapies that change lives. You will collaborate with cross-functional teams to ensure high-quality deliverables and effective budget management, all while navigating complex regulatory environments. This role reports to the Portfolio Operations Lead, Early Development Clinical Operations and is based in the United Kingdom.

Hybrid Working: At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

Key Responsibilities:

• Ensuring effective planning, oversight, and execution of Clinical Development Plans and pre/post-POC trials for assigned assets and due diligence projects.
• Providing expert clinical operations strategy input to Primary Focus Area and/or Asset Teams.
• Developing clinical program budgets and resource estimates for assigned assets and due diligence projects; provides oversight of budget and resources during execution of clinical trials.
• Providing oversight and guidance to extended team members in completing program deliverables according to agreed timelines and quality standards.
• Providing input on clinical operational matters for interactions with regulatory authorities and key opinion leaders.
• Participating in and/or facilitating cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables.
• Working with teams to proactively identify and manage operational risks that arise during program and trial conduct.
• Ensuring close collaboration between Early and Late-Stage Clinical Operations Lead(s).
• Representing Clinical Operations in inspection readiness activities.
• Participating in resource allocation across the department as required for portfolio delivery and non-drug project initiatives/process improvements.
• Acting as a change champion for Clinical Operations across the global organization.
• Maintaining compliance of direct reports with Astellas policies, procedures, and all associated training.

Essential Knowledge & Experience:

• Significant expertise in early drug development programs (across Phases I-II).
• Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally.
• In-depth knowledge of ICH/GCP guidelines and multinational clinical trial regulations.
• Proven track-record in identifying and leading global process or system improvement initiatives.
• Must have experience working across multiple phases of development and in multiple therapeutic areas.
• Strong written and verbal communication skills, with fluency in English essential.

Preferred Experience:

• Ability to work flexibly across multiple time zones and travel internationally (up to 25%).
• Direct people management experience is highly desirable.

Education:

• Bachelor’s degree or equivalent.

This is a permanent full-time position based in the United Kingdom. This position follows our hybrid working model, requiring a blend of home and a minimum of 1 day per month in our Bourne, London office. Flexibility may be required in line with business needs. 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.