Beschreibung

As a Clinical Lead in Early Clinical and Experimental Therapeutics, you will design and oversee innovative clinical studies, ensuring scientific rigor and safety while collaborating with diverse teams to drive early development strategies and decisions.

Anforderungen

• •Experience in basic science, translational medicine, and/or clinical research
• •Knowledge and mindset in translational research
• •Experience in the conduct of late phase clinical trials
• •Very good communication skills (verbal and written)
• •Demonstrated capability to challenge decisions and status quo
• •Ability to work within a matrix organization
• •International/intercultural working skills
• •Open-minded to apply new digital and/or AI-driven solutions
• •Advanced degree: M.D. or M.D./Ph.D with at least 1-5 years of research experience
• •Broad immunology knowledge base
• •Able to acquire and apply new technical skills
• •Postgraduate residency training; laboratory research in industry or academia is a plus
• •Fluent in English

Aufgaben

• •Design early development and ECET plans
• •Create safe and informative First-In-Human studies
• •Supervise study execution and medical monitoring
• •Review and interpret clinical results
• •Author ECET-related clinical documentation
• •Interact with cross-functional managers and partners
• •Participate in dose selection for First-In-Human studies
• •Ensure follow-up on studies and project timelines
• •Present data at internal and external meetings
• •Emphasize strengths of the TMU and Clinical Patient Sciences
• •Engage in scientific challenges of early clinical development
• •Maintain Clinical Trial standards and communication processes
• •Produce high-quality documents with strong writing skills
• •Manage timelines through cross-functional planning
• •Make decisions on protocol design and safety
• •Design and conduct early clinical development studies
• •Review and approve study documentation
• •Coordinate clinical team for study setup
• •Ensure documentation for Ethics Committees and Health Authorities
• •Ensure scientific soundness of study conduct
• •Prepare and review interim investigator reports
• •Lead Dose Escalation Meetings and document decisions
• •Review Adverse Event reports
• •Participate in data review and validation meetings
• •Prepare Key Results Memo and Clinical Study Report

Benefits