Neuroscience Clinical Development Lead

vor 1 Woche


Basel, Basel-Stadt, Schweiz Roche Vollzeit

Key Responsibilities

As a Lead Medical Director in our Neuroscience Clinical Development team, you will play a crucial role in the late-stage development of our MS product. Your primary responsibilities will include leading the design, development, and execution of clinical studies, as well as collaborating with cross-functional teams to develop product safety profiles and clinical sections of investigator brochures.

Main Accountabilities

  • Develop and execute clinical development plans for assigned molecule(s)/indication(s)
  • Conduct health authority interactions, providing clinical science information and responding to questions
  • Collaborate with regulatory teams to prepare and submit regulatory filings and documentation
  • Provide clinical science information and input for regulatory submissions and other regulatory processes

Requirements

  • Board-certified neurologist with experience in late-stage drug development (Phase II-III) and broad scientific and therapeutic expertise
  • 4+ years of pharma/biotech industry experience with significant experience designing and conducting clinical trials
  • Experience working with GCP, ICH, FDA, EMA, and other relevant guidelines and regulations


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