Clinical Trial Lead

Astellas Pharma Inc.; France; Hybride; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Astellas Pharma Inc. cherche un Clinical Trial Lead pour diriger des essais cliniques en oncologie. Le candidat sera responsable de la planification, de l'exécution et de la conformité des essais, travaillant avec des équipes interfonctionnelles pour garantir des résultats de qualité. Ce poste est basé au Royaume-Uni, avec un modèle de travail hybride.

Qualifications

• Expérience avérée en gestion d'essais cliniques en oncologie à l'échelle européenne ou mondiale.
• Compétences solides en gestion de projets et leadership.
• Excellente compréhension des lignes directrices ICH/GCP.

Responsabilités

• Gérer les opérations quotidiennes des essais pour atteindre les objectifs du projet.
• Diriger des équipes d'essai interfonctionnelles, y compris la gestion des fournisseurs.
• Développer des documents d'étude essentiels et des systèmes pour l'excellence opérationnelle.

Connaissances

Project Management

Leadership

Communication

Regulatory Compliance

Problem-Solving

Formation

Bachelor’s Degree or equivalent

Description du poste

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Clinical Trial Lead (CTL) – Oncology Early Development

About Astellas: At Astellas, we are a progressive health partner committed to delivering value and outcomes where needed. We focus on innovative science, especially in areas with high patient need, including rare and under-served diseases, as well as life-threatening or life-limiting conditions. Our approach involves working closely with patients, healthcare professionals, and regulatory bodies to ensure patient-centric development and access to therapies. We aim to develop solutions that truly meet patient needs and improve standards of care.

The Opportunity: As the Clinical Team Lead, you will oversee the planning, setup, and execution of assigned drug trials, including interventional, pharmacology, and post-marketing studies. Reporting to the Clinical Operations Lead, you will lead cross-functional teams to ensure efficient and compliant trial conduct. This role is based in the UK with a hybrid working model, combining office and remote work.

Key Responsibilities:

1. Managing daily operations of trials to meet project goals, ensuring compliance with GCP/ICH and regulatory standards.
2. Leading cross-functional trial teams, including vendor management and performance oversight.
3. Providing guidance to team members on deliverables, timelines, and quality standards, escalating issues as needed.
4. Developing core study documents and systems to ensure operational excellence.
5. Facilitating collaboration and problem-solving to mitigate risks and ensure timely trial completion.

Essential Knowledge & Experience:

• Extensive experience managing oncology clinical trials across Europe or globally.
• Proven project management and leadership skills.
• Strong understanding of clinical trial design, planning, and management.
• Excellent knowledge of ICH/GCP guidelines and regulatory requirements.
• Effective communication and administrative skills.

Preferred Experience:

• Deep knowledge of clinical drug development processes and trial management.

Education:

• Bachelor’s Degree or equivalent.

Additional Information:

• This is a permanent, full-time position.
• Based in the UK with a hybrid work model, requiring at least 1 day per quarter in the office.

We are an equal opportunity employer, welcoming applicants regardless of race, color, religion, sex, national origin, disability, veteran status, or other protected characteristics.