Clinical Trial Lead (m/w/d)

As Clinical Trial Leader you drive the operational performance of global Phase III trials, guiding cross-functional teams to deliver on timelines, quality, and budget. You act as the primary contact for stakeholders and ensure rigorous GCP/ICH compliance while shaping study design and strategic decisions. You mentor staff, oversee trial documentation, and optimize processes with tools and analytics to support ambitious project goals.

• Lead global, cross-functional trial teams to deliver complex Phase III studies with focus on timelines, quality and strategic oversight
• Serve as primary interface for internal and external stakeholders on trial progress, governance, and issue resolution
• Author and manage essential trial documentation (protocols, ICFs, study management plans, quality plans)
• Provide strategic input and medical decisions in early development in alignment with medical colleagues
• Ensure adherence to GCP/ICH, SOPs, and regulatory requirements across studies
• Lead interdisciplinary core trial teams (data management, statistics, PK, clinical operations) and facilitate Trial Oversight Meetings
• Collaborate cross-functionally to hit milestones and proactively manage risks and mitigations
• Manage and mentor clinical operations staff, including performance and development planning
• Coach on project planning, risk management, and adoption of processes and technology tools
• Monitor trial budgets, scope, schedule and change control; ensure deliverables on time and within budget
• Plan trial quality and risk monitoring; implement CAPAs as needed
• Provide staff training on processes, systems, and competency frameworks
• Consult with pharmacogenetics and safety experts on preclinical data, SAEs, SUSARs and side effects
• Demonstrate therapeutic area expertise (oncology, inflammatory, CMR) in study design and execution

• Master’s or higher degree in life sciences; physician would be a plus
• Minimum of 5 years (10 years for Senior CTL) of global clinical operations management, preferably in a CRO
• Experience in setup and conduct of Phase III trials including design and protocol writing
• Knowledge of GCP/ICH CTR and local regulatory requirements
• Therapeutic area experience in oncology, inflammatory or CMR; experience in respiratory, CNS, ophthalmology is advantageous
• Proficient in Microsoft Word, Excel, PowerPoint
• Fluent in English
• Strong communication, organizational and problem-solving skills
• Strong leadership and stakeholder management abilities
• Proven ability to manage competing priorities and deliver on quality and timelines

• strong communication
• organizational excellence
• problem-solving
• GCP/ICH knowledge
• protocol writing
• study design