Key Responsibilities

• Lead the planning, execution, and delivery of international Phase I-III clinical studies
• Ensure successful study conduct through effective oversight of CROs and external vendors, with accountability for quality, timelines, budgets and study objectives
• Establish and drive study governance, including risk management, issue resolution and performance oversight throughout the study lifecycle
• Collaborate closely with cross-functional teams to align clinical, scientific, regulatory and operational priorities
• Contribute to protocol development, study planning and operational strategies to support efficient trial execution
• Ensure compliance with ICH-GCP, applicable regulations and internal standards while maintaining inspection readiness
• Support interactions with health authorities and contribute to regulatory submissions, inspections and audits
• Promote a culture of collaboration, accountability and continuous improvement

Your Profile

• Advanced degree in Life Sciences, Pharmacy, Medicine or a related scientific field; PhD preferred
• Proven track record of successfully leading international Phase I-III clinical studies
• Strong expertise in CRO and vendor oversight, study governance and operational risk management
• Sound understanding of clinical trial design, protocol development and study execution
• In-depth knowledge of ICH-GCP and global clinical research regulations

Our employees are our greatest asset. And to show our appreciation, we offer attractive benefits:

• Your work-life balance is important to us. We offer flexible working hours with the option of working a proportion of those hours remotely, 30 annual vacation days and an excellent cafeteria
• Attractive salaries and success-based bonuses for all medac employees
• Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes
• A funded pension scheme and other social benefits
• We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling
• We promote sports and activities to improve our employees’ health

• Experience with regulatory submissions, health authority interactions and inspection readiness activities is highly desirable
• Strong leadership, communication and stakeholder management skills, coupled with a collaborative and results-driven mindset
• Fluency in English is essential; German language skills are beneficial