Lead Medical Director

5 days ago

Welwyn Garden City, Hertfordshire, United Kingdom Roche Full time

About the Role

Roche is 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 development of our Multiple Sclerosis (MS) product, working closely with cross-functional teams to design, develop, and execute clinical studies.

Key Responsibilities

  • Lead the design, development, and execution of clinical studies, providing clinical science information to health authorities with minimal supervision.
  • Collaborate with team members to develop product safety profiles, clinical sections of investigator brochures, presentations, and other materials.
  • Monitor study progress against objectives and plans, identifying and communicating any issues, challenges, and potential strategies for resolution.
  • Contribute to the development of regulatory filings and other regulatory documentation, providing clinical science information and input for submissions.
  • 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

  • MD and board certification in Neurology, 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 (specifically Phase II-III drug development).
  • Experience authoring a global development plan and working with data analysis, interpretation, and clinical relevance.
  • Regulatory knowledge of medical aspects of GCP, ICH, FDA, EMA, and other relevant guidelines and regulations.

About Roche

Roche is a leading healthcare company that discovers, develops, and delivers innovative medicines and diagnostic solutions to improve people's lives. We are committed to advancing healthcare and improving the lives of patients worldwide.

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