Non-clinical Specialist

• Design and Strategy: Draft non-clinical drug development plans aligned with timelines, regulatory requirements, the intended indication, and patient population
• CRO Management: Evaluate and manage CROs for non-clinical studies, including contracting and relationship management
• Study Oversight: Ensure studies comply with protocols, guidelines, and quality standards. Monitor progress and address issues to guarantee timely completion
• Data Review: Review and advice on study results, generate cross-study summaries, and draw scientific conclusions
• Regulatory Documentation: Prepare study summaries, cross-study analyses, and materials for regulatory meetings
• Collaboration: Work with internal teams to integrate non-clinical findings into drug development strategies and regulatory submissions. The role reports directly to the Chief Scientific Officer (CSO)

• Master’s or preferably Ph.D degree in Pharmacy, Biochemistry, Molecular Biology, Medical or Veterinary biosciences or equivalent in a relevant field
• A minimum of 3 years working knowledge of, and experience in, drug development
• Experience in regulatory toxicology and toxicological tests
• Knowledge in ICH, OECD test guidelines and FDA and EMA guidance documents
• Experience with Standard Operating Procedures (SOPs) and quality systems
• Experience working with CROs or other stakeholders
• Excellent command of English, both written and spoken

Experience in clinical trials and CMC

• A competitive salary
• A supportive learning environment
• Fun and diverse working environment
• Balanced working environment
• Collaborative and flexible working environment
• Actively ensure work-life balance by promoting sports, culture and wellbeing activities with company benefits