Your mission
As a Medical Director* you will provide medical input and scientific advice for AiCuris projects. Furthermore, you will successfully design, conduct, and report international clinical trials in the respective subject area in collaboration with the AiCuris project team, external consultants, service providers, and ethical / regulatory bodies.
Responsibilities
- Provide clinical and medical input (e.g., regarding unmet needs, translatability into patients or feasibility) at any stage during the R&D-value chain.
- Responsible for the translation of research projects into clinical trials to prove the value of projects.
- Development of the clinical part of the project development plan for a compound.
- Development of clinical trial protocols and provision of clinical input in the conception of CRFs (paper or electronic).
- Creation of the trial reports, critical review and quality checks of the clinical data.
- Development of the clinical part of the investigator brochure, specifically the risk benefit section, information to the investigators and reference safety information.
- Clinical trials: Responsible for medical monitoring, medical input, online follow up of patient data, AEs and SAEs follow up, narratives, participation in the preparation of statistical analysis plan and tables, figures, and listings.
- Interaction with investigators, coordinating investigator and the key experts, e.g., investigator meeting presentations, monitors training, regular contacts with investigators and experts. Establishment of and working with DSMBs.
- Overall supervision of the trial conduct in close working collaboration with the Clinical Trial Manager.
- Development of the clinical part of regulatory documents, e.g., briefing books, summary documents, answer questions to authorities.