Director Clinical Studies and Medical Affairs (m/f/d)

For the Research and Basic Technologies Department of our Tübingen location, we are looking for a

Director Clinical Studies and Medical Affairs (m/f/d)

Your Responsibilities

• Leading the clinical studies and medical affairs department
• Coordinating and monitoring of project and study plans and associated work packages, including timelines, budget and resource allocation
• Creating and maintaining a comprehensive overview of all ongoing studies and providing regular status updates to general management
• Supporting the development of global clinical registration strategies
• Identifying and recommending external project and cooperation partners, including KOL management
• Reviewing interim study results, final study reports and interpreting study outcomes
• Reviewing and monitoring the analysis, provision and documentation of scientific and medical data for regulatory approval processes and regulatory requirements (including preparation of submission dossiers for IRBs and regulatory authorities)
• Overseeing the creation of clinical evidence and conducting literature research for clinical evaluations, including proof of clinical marketing claims

Your Skills

• A degree in Medicine, Biotechnology, Medical Technology, or a related field
• Several years of leadership experience, as well as professional experience in clinical studies, preferably in the medical technology
• Strong knowledge of study planning, execution, and monitoring, as well as project planning and budgeting
• Experience in collaborating with external partners and managing partnerships
• Strong expertise in managing literature and knowledge databases, including the research, analysis, and structuring of medical and scientific information using modern methods (e.g., AI tools)
• Knowledge of regulatory requirements for clinical studies in Europe (e.g. MDR) and the USA (e.g. FDA), including the associated literature searches
• Excellent communication skills in both written and spoken English and German
• Structured, solution-oriented approach to work with the ability to maintain an overview in a dynamic environment
• A high level of initiative, teamwork, and leadership skills