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Lead Medical Director Neuroscience, Welwyn
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Location:
Job Category:
Other
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EU work permit required:
Yes
Job Reference:
4be24269d22b
Job Views:
5
Posted:
02.06.2025
Expiry Date:
17.07.2025
Job Description:
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.
Responsibilities:
* Leading design, development, and execution of clinical studies and engaging in health authority (HA) interactions, including developing briefing packages and responding to HA questions with minimal supervision.
* Collaborating on product safety profiles, investigator brochures, presentations, and other materials.
* Monitoring study progress, addressing variances, and communicating issues and strategies.
* Contributing to regulatory filings and documentation, including label and packaging language.
* Closing out clinical studies, securing data, and completing reporting.
* Acting as a medical monitor for studies or delegating this role appropriately.
Candidate Profile:
* MD and board certification in Neurology, with relevant clinical, scientific, and trial experience in the therapeutic area.
* At least 4 years of pharma/biotech industry experience, especially in Phase II-III drug development; pediatric experience is a plus.
* Experience in developing global development plans and data analysis.
* Publication in peer-reviewed journals preferred.
* Knowledge of GCP, ICH, FDA, EMA guidelines, and regulations.
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