Senior Scientist — Regulatory Cardiac Safety/Electrophysiology (Scientist II) at Eurofins DiscoverX
Interview Preparation Plan
This role focuses on the critical area of cardiac safety and electrophysiology within the regulatory framework of drug development. The Senior Scientist will be responsible for designing, conducting, and interpreting non-clinical studies to assess the potential for drug candidates to cause adverse effects on the heart's electrical system. This involves a deep understanding of electrophysiological principles, regulatory guidelines (such as ICH E14), and their application in drug safety assessments. The position requires expertise in various electrophysiology techniques and methodologies, ensuring that studies meet regulatory standards and contribute to informed decision-making regarding drug safety and development. The Senior Scientist will play a key role in the regulatory submission process, providing essential data and analysis to support drug approvals.
Key Responsibilities
- Design and execute in vitro and in vivo cardiac safety and electrophysiology studies according to regulatory guidelines (e.g., ICH E14, CiPA initiative).
- Analyze and interpret complex electrophysiological data (e.g., hERG, action potentials, ECGs) and provide comprehensive reports.
- Contribute to regulatory submissions by preparing relevant sections of IND, NDA, and other regulatory documents.
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