Nonclinical Lead

We are looking for a nonclinical lead with a toxicology and nonclinical drug development background to join our team. The role involves managing all nonclinical studies, scientific review of study plans, regulatory document review and writing, and participation in strategic discussions.

Responsibilities:

• Management and monitoring of all non-clinical studies
• Review and oversee nonclinical studies – Provide expert evaluation and guidance on nonclinical study plans and reports.
• Regulatory support – Review regulatory documents as a nonclinical SME and contribute to regulatory writing (IB, submission documents) as needed.
• Strategic input in nonclinical development – Offer expert guidance on nonclinical development strategies.
• Participation in team meetings –provide updates on study monitoring
• Expert consultation – Take part in dedicated expert meetings as needed.
  
  

• Extend experience in nonclinical drug development.
• Experience with botanical drugs (preferred)
• Experience in regulatory interactions (e.g., FDA, EMA)
• Inhalation toxicology experience – a distinct advantage.
• Proven experience in reviewing and supervising nonclinical studies.
• Regulatory writing skills (e.g., IB, submission documents).
• Study monitoring experience in nonclinical research.
• Ability to collaborate across multidisciplinary teams and interact with key stakeholders.
• Strong attention to detail and ability to analyze and summarize complex scientific data.