Clinical Operations Lead I - #143078

Description

Clinical Operations Lead I

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then 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 are guiding 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. At Astellas, Patient Centricity isn’t 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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

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. The position can be based in either United Kingdom or United States.

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 Activities

• 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

• Extensive experience working on global drug development programs with expertise in ophthalmology, specifically retinal experience, but open to candidates with backgrounds in cell and gene therapy or rare diseases.
• 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.
• Excellent written and verbal communication skills; fluency in English is required.
  
  

Education/Qualifications

• Bachelor’s degree or equivalent.
  
  

Preferred Experience

• Significant experience in Phase 3 and late-stage development is preferred
• 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 can be based in either United Kingdom or United States.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our 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.