Medical Director Neuroscience Lead
Vor 2 Tagen
About the Position
">Roche is seeking a highly skilled Medical Director to join our neuroscience clinical development team in Basel, Switzerland. This individual will play a key role in supporting the late-stage development of our MS product and contributing to the development of the clinical development plan for assigned molecule(s)/indication(s).
The ideal candidate is a board-certified neurologist with extensive knowledge of all phases of late-stage drug development (Phase II-III) and broad scientific and therapeutic expertise. They will also have the opportunity to work on a paediatric development plan.
The successful candidate will be responsible for leading design, development, and execution of clinical studies and actively participating in health authority 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.
Key Responsibilities:
- Design, develop, and execute clinical studies with minimal oversight.
- Collaborate with cross-functional teams to develop product safety profiles, clinical sections of investigator brochures, presentations, and other materials.
- Monitor study progress against objectives and plans, identifying and addressing variances proactively.
- Take an active role in completing and submitting regulatory filings and other regulatory documentation with internal partners/stakeholders.
- Provide clinical science input for regulatory submissions and processes, including developing label and packaging language.
- Collaborate with clinical operations to close out clinical studies, secure data, and complete study reporting.
About You
You will bring a strong profile and expertise to this role, including:
- MD and board certificate in Neurology, along with relevant clinical, scientific, and clinical trial/development experience in the same/similar therapeutic area.
- A minimum of 4 years of pharma/biotech industry experience with significant experience designing and conducting clinical trials, specifically Phase II – III drug development. Experience in pediatric drug development is a plus.
- Experience authoring global development plans and working with data analysis, interpretation, and clinical relevance principles.
- Publishing results of a scientific study in a peer-reviewed journal is preferred.
- Familiarity with 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.
Salary and Benefits
The estimated annual salary for this position is CHF 180,000 - CHF 220,000 depending on qualifications and experience.
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