Chief Medical Officer
2 days left
- Experience Level
This is a unique opportunity to take on an instrumental role within a successful biotech organisation during an exciting period of change and growth.
- Direct and lead development programs and strategies based on thorough understanding of regulations.
- Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities.
- Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
- Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders.
- Building a network and be the interface with Key Opinion Leaders, with clinical/scientific and supervisory boards as well with shareholders.
- MD PhD- medical, biochemistry or chemistry
- 15 years minimum experience in clinical and technology focused practice.
- Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations.
Knowledge and Skills:
- Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus
- Experience in allocating resources
- Experience with, or strong knowledge of drug development
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