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Senior Lead Medical Director

vor 1 Woche


Zürich, Zürich, Schweiz PKS Personal AG Vollzeit
Position Summary

This position involves leading the design, development, and execution of clinical studies, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements. The ideal candidate will possess strong clinical science expertise, excellent collaboration skills, and the ability to work effectively in a fast-paced environment.

Key Responsibilities:
  1. Design and Execution: Lead design, development, and execution of clinical studies, ensuring compliance with GCP and regulatory requirements.
  2. Cross-Functional Collaboration: Collaborate with colleagues to develop product safety profiles, clinical sections of investigator brochures, presentations, and other materials.
  3. Study Progress Monitoring: Monitor and report on study progress against objectives and plans, identifying and resolving any issues or variances.
  4. Regulatory Filings and Documentation: Ensure timely completion and submission of regulatory filings and documentation, including briefing packages and responses to HA questions.
  5. Clinical Science Expertise: Provide clinical science information and input for regulatory submissions, label development, and packaging language.
  6. Closing Out Clinical Studies: Collaborate with clinical operations to secure data and complete study reporting.
Requirements and Qualifications

To be successful in this role, you must possess:

  • A board certificate in Neurology and relevant clinical, scientific, and clinical trial experience in the same or similar therapeutic area.
  • 4+ years of pharma/biotech industry experience with significant experience designing and conducting clinical trials (one or more trials) in Phase II – III drug development.
  • Experience authoring a global development plan 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, ICH, FDA, EMA, and other relevant guidelines and regulations.