Clinical Operations Lead I

TN United Kingdom; United Kingdom; On-site; GBP 70,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a Clinical Operations Lead to oversee strategic and operational aspects of asset development. This permanent full-time role requires extensive experience in global drug development and strong leadership skills, with a focus on collaboration and regulatory compliance. The position offers a hybrid working model based in the UK or US.

Qualifications

• Extensive experience in global drug development, particularly in ophthalmology or related fields.
• Deep knowledge of ICH/GCP guidelines and multinational trial regulations.
• Proven experience in process or system improvements.

Responsibilities

• Overseeing the Integrated Evidence Generation Plan and Clinical Development Plan.
• Managing budgets and resources, ensuring timelines and quality standards are met.
• Providing leadership and guidance to team members.

Skills

Leadership

Collaboration

Communication

Education

Bachelor’s degree or equivalent

Job description

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Clinical Operations Lead I, United Kingdom

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EU work permit required:

Yes

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Job Reference:

3866d9661f39

Job Views:

4

Posted:

21.05.2025

Expiry Date:

05.07.2025

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Job Description:

Description

About Astellas: At Astellas, we are a progressive health partner dedicated to delivering value and outcomes. We focus on innovative science in areas with high patient needs, including rare and life-threatening diseases. We collaborate directly with patients, healthcare professionals, and regulatory authorities to ensure patient-centric development and access to new therapies. Our goal is to support stakeholder communities and improve standards of care globally.

The Opportunity:

As a Clinical Operations Lead (Associate Director) at Astellas Pharma, you will oversee strategic and operational aspects of asset development. Your role involves cross-functional collaboration, budget management, and navigating complex regulatory environments. The position is based in the UK or US, with a flexible hybrid work model.

Key activities include:

1. Overseeing the Integrated Evidence Generation Plan, Global Development Plan, and Clinical Development Plan to ensure alignment with strategic goals.
2. Representing Clinical Operations in asset teams and process improvement projects.
3. Managing budgets and resources, ensuring timelines and quality standards are met.
4. Providing leadership and guidance to team members.
5. Representing the region in KOL interactions and communications with Health Authorities.

Essential Knowledge & Experience:

• Extensive experience in global drug development, particularly in ophthalmology or related fields like cell and gene therapy or rare diseases.
• Strong leadership and collaboration skills.
• Deep knowledge of ICH/GCP guidelines and multinational trial regulations.
• Proven experience in process or system improvements.
• Excellent communication skills in English.

Education/Qualifications:

• Bachelor’s degree or equivalent.

Preferred Experience:

• Significant experience in Phase 3 and late-stage development.
• Ability to work across time zones and travel internationally (up to 25%).
• People management experience is highly desirable.

Additional Information:

• This is a permanent full-time role.
• Based in UK or US with hybrid working arrangements.
• Flexibility required for business needs and travel.

We are an equal opportunity employer, committed to diversity and inclusion.