Clinical Operations Lead (Director) - Oncology in London

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, including awareness and escalation of high impact quality-related topics for assigned programs.
• Providing input on clinical operational matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally, as applicable.
• 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 according to established objectives, milestones, and goals.
• Working with teams to proactively identify and manage operational risks that arise during program and trial conduct, including escalation to Primary Operations Lead, functional management, and external vendor management to accelerate mitigation (as appropriate).
• Ensuring close collaboration between Early and Late-Stage Clinical Operations Lead(s), including providing strategic and operational input during development and as the assets transition from early to late-stage development.
• Representing Clinical Operations in inspection readiness activities including coordination of trial team quality deliverables.
• Providing oversight and direction to trial team members for evaluation and implementation of patient-focused strategies for assigned trials.
• 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.
• Significant expertise in early drug development programs (across Phases I-II) executing complex global drug development programs and trials.
• Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives.
• 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.

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. At Astellas, Patient Centricity is not 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 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. We take a patient-focused approach that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.

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.