Lead Medical Director Neuroscience

4 weeks ago


Welwyn Garden City, Hertfordshire, United Kingdom Roche Full time
The Role

We are seeking a highly experienced Lead Medical Director to join our Neuroscience Clinical Development team in Basel, Switzerland. As a key member of our team, you will play a critical role in the late-stage development of our Multiple Sclerosis (MS) product.

Key Responsibilities
  • Lead the design, development, and execution of clinical studies, providing clinical science information to health authorities with minimal supervision.
  • Collaborate with cross-functional teams to develop product safety profiles, clinical sections of investigator brochures, and other materials.
  • Monitor study progress, identify variances, and proactively communicate issues and potential strategies to resolve them.
  • Contribute to regulatory filings and submissions, including developing label and packaging language.
  • Collaborate with clinical operations to close out clinical studies, secure data, and complete study reporting.
  • Act as a medical monitor for assigned studies or delegate this responsibility as needed.
Requirements
  • Board-certified neurologist with relevant clinical, scientific, and clinical trial/development experience in the same/similar therapeutic area.
  • 4+ years of pharma/biotech industry experience, with significant experience designing and conducting clinical trials, specifically Phase II-III drug development.
  • Experience authoring global development plans and working with data analysis, interpretation, and clinical relevance.
  • Regulatory knowledge of GCP, ICH, FDA, EMA, and other relevant guidelines and regulations.

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