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Description

Clinical Trial Lead (CTL)

About Astellas: At Astellas, we are making treatments that matter to people. We focus on patient-centric healthcare, developing innovative medicines in immunology, oncology, and urology to improve lives. Our approach is grounded in understanding the patient experience and translating early science into life-saving treatments.

The Opportunity: As the Clinical Team Lead, you will oversee the planning, setup, and execution of clinical trials, including interventional drug trials, clinical pharmacology studies, and post-marketing trials. Reporting to the Clinical Operations Lead, you will lead cross-functional teams to ensure trials are conducted efficiently and in compliance with regulations. This role is based in the UK with a hybrid working model.

Key Responsibilities:

1. Manage daily operations of assigned trials, ensuring compliance with GCP/ICH and regulatory standards.
2. Lead cross-functional trial teams, including vendor management and performance oversight.
3. Guide study team members to meet deliverables on time and uphold quality standards.
4. Develop study documents, plans, and systems to ensure operational excellence.
5. Facilitate collaboration and problem-solving to mitigate risks and meet trial milestones.

Essential Knowledge & Experience:

• Experience managing clinical trials.
• Project management and leadership skills.
• Strong knowledge of clinical development processes and trial design.
• Understanding of ICH/GCP guidelines and regulations.
• Excellent communication and organizational skills.

Preferred Experience & Education:

• Additional experience in clinical trial processes and management.
• Bachelor’s Degree or equivalent.

Additional Information:

• Permanent full-time position based in the UK.
• Hybrid work model requiring at least one day per quarter in the office.
• Equal opportunity employer.