About Astellas:
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 (Associate 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.
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:
- Overseeing the Integrated Evidence Generation Plan (iEGP), Global Development Plan (GDP), and Clinical Development Plan (CDP) to ensure alignment with strategic goals.
- Representing Clinical Operations in Asset Teams and cross-functional process improvement projects, driving collaboration and innovation.
- Managing departmental budgets and resources, ensuring compliance with timelines and quality standards.
- Providing oversight and guidance to team members, fostering a culture of excellence and accountability.
- Acting as a regional representative for KOL interactions and communications with Health Authorities, enhancing Astellas global presence.
Essential Knowledge & Experience:
- Significant expertise in early drug development programs (across Phases I-II) within Oncology in a global capacity.
- Strong leadership skills with the ability to collaborate effectively across Clinical Operations and cross-functional teams.
- 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.
- Strong written and verbal communication skills, with fluency in English essential.
Education:
- Bachelor’s degree or equivalent.
Preferred Experience:
- Ability to work flexibly across multiple time zones and travel internationally (up to 25%).
- Direct people management experience is highly desirable.
Additional Information:
- This is a permanent full-time position.
- The position is based in the United Kingdom.
- This position follows our hybrid working model. Role requires 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. 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.
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