Lead Medical Director Neuroscience
vor 14 Stunden
The Position
Roche is recruiting for a Lead Medical Director to join our neuroscience clinical development team based in Basel headquarters to support the ongoing late-stage development of our MS product. In this role, you will have the opportunity to make major contributions to the development of the clinical development plan for assigned molecule(s)/indication(s)
This role is ideal for a board-certified neurologist with an in-depth knowledge of all phases of late-stage drug development (Phase II-III) and broad scientific and therapeutic expertise. You will also have the opportunity to work on a paediatric development plan.
You will be responsible for:
Leading design, development, and execution of clinical studies and play an active role in health authority (HA) interactions providing clinical science information such as the development of briefing packages and responses to HA questions with little to no supervision from more experienced Medical Directors
Collaborating with others in the development of product safety profiles, clinical sections of investigator brochures, presentations and other materials
Collaborating with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicates any issues, challenges and potential strategies to resolve such
Taking an active role with other CST members, regulatory and other internal partners/stakeholders in completing and submitting regulatory filings and other regulatory documentation.
Providing clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.
Collaborating with relevant team members and clinical operations to close out clinical studies, secure data and complete study reporting
Acting as a medical monitor for assigned studies or delegates this responsibility appropriately
You will bring the following profile and expertise:
MD and board certificate in Neurology is a must along with relevant clinical, scientific, and clinical trial/development experience in the same/similar therapeutic area
4 or more years of pharma/biotech industry experience with significant experience designing and conducting clinical trials one or more trials) specifically Phase II – III drug development. Experience in pediatric drug development is a plus
Experience authoring a global development plan as well as 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 (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations is required
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