Global Neuroscience Medical Lead
vor 2 Monaten
About the Role
Roche is seeking a Clinical Development Director for Neuroscience to support the ongoing late-stage development of our MS product. This individual will lead the design, development, and execution of clinical studies and play an active role in health authority interactions.
Key Responsibilities
- Leading clinical studies and interacting with health authorities to provide clinical science information.
- Collaborating with others to develop product safety profiles, clinical sections of investigator brochures, and presentations.
- Collaborating with team members to measure and monitor study progress against objectives and plans.
- Providing clinical science information and input for regulatory submissions.
- Closing out clinical studies, securing data, and completing study reporting.
- Acting as a medical monitor for assigned studies or delegating this responsibility.
Requirements
- MD and board certificate in Neurology with relevant clinical, scientific, and clinical trial/development experience in the therapeutic area. 4 or more years of pharma/biotech industry experience with significant experience designing and conducting clinical trials. Experience in pediatric drug development is a plus.
- Experience authoring a global development plan and significant experience working with the principles and techniques of data analysis, interpretation, and clinical relevance. Experience publishing results of a scientific study in a peer-reviewed journal is preferred.
- Regulatory: Knowledge of medical aspects of GCP, ICH, FDA, EMA, and other relevant guidelines and regulations is required.
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