Non Clinical Expert

For our client, an established and family owned life sciences company south of Freiburg we are searching for a Non-Clinical development Lead. In this role you will be responsible of managing projects and advising teams on non-clinical development matters. You will have the chance to work with various products (small molecules, biologics, ATMPs, other drug products) in international context.

Your tasks:

• Acting as an expert adviser on non-clinical guidance to project teams covering a broad portfolio of products and as an expert in global interactions such as scientific advice meetings
• Managing non-clinical development programs according to the regulations
• You will manage and monitor non-clinical studies
• Audit non clinical CROs
• Toxicological evaluations of API, impurities and excipients
• You will be responsible for the writing and reviewing of non clinical documentation, including doing gap analysis on existing documentation
• Revision of non-clinical parts of product information texts (Summary of product characteristics, Patient information leaflet)
• Due diligence

Your profile:

• Advanced degree in medicine, life sciences or veterinary medicine or similar field
• Know-how in toxicology, pharmacokinetics and pharmacodynamics
• Good practical experience in non-clinical drug development (especially with ATMPs or biological products is a plus)
• Relevant experience in the life sciences industry (pharmaceutical or biotech companies, regulatory authorities or non-clinical CROs)
• Good knowledge of Good Laboratory Practice and non-clinical requirements
• Experience within silico tools is beneficial
• Ability to understand and to communicate complex non-clinical development scenarios
• Excellent English skills
• Possibility to go once a month on site for a few days (the company provides accomodation and pays for the travel)

What the company offers:

• An interesting and diversified roles in which one can grow and develop
• A friendly and dynamic working environment with flexibility (80% remote - once a month on site model, flexible working hours, flat hierarchy)
• A fair compensation with company benefits (pension, gym memberships...)
• Training possibilites

If you are interested apply here or send me your CV with contact details at claire.renouf@catalystcareers.com

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.