Senior Medical Director

7 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, identify variances, and proactively communicate issues and potential strategies for resolution.
  • Contribute to regulatory filings and 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

  • 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 (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.

What We Offer

As a Lead Medical Director at Roche, you will have the opportunity to make significant contributions to the development of our MS product, working with a talented team of professionals in a dynamic and collaborative environment.



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