Clinical Operations Lead

Astellas Pharma; London; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a Clinical Operations Lead (Associate Director) for their oncology division. This role involves overseeing strategic input throughout the asset development lifecycle, managing budgets, and collaborating with cross-functional teams. Candidates should have significant experience in early drug development and strong leadership skills, with a commitment to patient-centric solutions.

Qualifications

• Significant experience in early drug development (Phases I-II) within Oncology.
• Deep knowledge of ICH/GCP guidelines and multinational clinical trial regulations.
• Proven ability to lead global process or system improvement initiatives.

Responsibilities

• Oversee the Integrated Evidence Generation Plan (iEGP) and Clinical Development Plan (CDP).
• Manage departmental budgets and resources, ensuring adherence to timelines.
• Provide oversight and mentorship to team members.

Skills

Leadership

Collaboration

Communication

Education

Bachelor’s degree or equivalent

Job description

Join to apply for the Clinical Operations Lead role at Astellas Pharma

Description

Clinical Operations Lead (Associate Director) – Oncology

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. Patient Centricity is a guiding principle for action at Astellas, encouraging all staff to foster a patient-centric culture.

We have developed ground-breaking medicines in immunology, oncology, and urology, extending and saving lives, enabling transplants, and improving quality of life for underserved conditions. Our focus is on translating early science into treatments that directly impact patients’ lives.

The Opportunity

As a Clinical Operations Lead (Associate Director), you will oversee strategic input and operational insights throughout the asset development lifecycle, directly influencing innovative therapies. You will collaborate with cross-functional teams to ensure quality deliverables and effective budget management within complex regulatory environments. This role reports to the Portfolio Operations Lead, Early Development Clinical Operations.

Hybrid Working

We support a flexible working model allowing you to work from home or in the office, with at least 1 day per month in our Bourne, London office. Flexibility may be needed based on business requirements, and candidates should be within a commutable distance.

Key Responsibilities

1. Oversee the Integrated Evidence Generation Plan (iEGP), Global Development Plan (GDP), and Clinical Development Plan (CDP) to ensure strategic alignment.
2. Represent Clinical Operations in asset teams and process improvement projects to foster collaboration and innovation.
3. Manage departmental budgets and resources, ensuring adherence to timelines and quality standards.
4. Provide oversight and mentorship to team members, promoting a culture of excellence and accountability.
5. Act as a regional representative for KOL interactions and communications with Health Authorities, enhancing global presence.

Essential Knowledge & Experience

1. Significant experience in early drug development (Phases I-II) within Oncology on a global scale.
2. Strong leadership skills with effective collaboration across Clinical Operations and other teams.
3. Deep knowledge of ICH/GCP guidelines and multinational clinical trial regulations.
4. Proven ability to lead global process or system improvement initiatives.
5. Excellent communication skills in English, both written and verbal.

Education

• Bachelor’s degree or equivalent.

Preferred Experience

• Ability to work across multiple time zones and travel internationally (up to 25%).
• Experience in direct people management is highly desirable.

Additional Information

• This is a permanent, full-time position based in the United Kingdom.
• Role requires a blend of home and at least 1 day/month in our London office, with flexibility based on business needs.

We are an equal opportunity employer, considering all qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, or any other protected characteristic.