Associate Director Biomarker Development (m/f/d)

• PhD in medicine, human biology, biology, biochemistry or a comparable field
  
• Many years of professional experience in managing programs in the biotechnology or pharmaceutical industry
  
• Profound expertise in the drug development process incl. manufacturing of pharmaceuticals (CMC, non-clinical, clinical, biomarker, regulatory)
  
• Profound therapeutic knowledge in the areas of immunology and immuno-oncology
  
• Responsible for development of appropriate biomarker strategies and processes to achieve the goals of the respective R&D program
  
• Active participation in Program Core Team as necessary and respective decision-making, core documents and development plans
  
• Leads and oversees assay development in assigned programs, including companion diagnostic development
  
• Provides state of the art biomarker input in regulatory documents (final study reports, IND, NDA documentation)
  
• Evaluation, analysis & interpretation of clinical biomarker data and preparation for decision-making

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