Exciting opportunity to lead safety assessment strategy during all non-clinical and clinical phases at Symphogen

As Senior Toxicologist at Symphogen, you will be responsible for non-clinical safety assessment strategy during the early pipeline, non-clinical, and clinical development phases. Lead activities in close collaboration with colleagues in Denmark and France. You will be the non-clinical safety subject matter expert in the project core team, in clinical study teams as well as in meetings with authorities when relevant. 

Your main tasks are:  

• Lead non-clinical safety strategies and activities 
• Independently design non-clinical safety studies 
• Provide toxicology, safety pharmacology, and In Vitro safety assessments 
• Support ongoing clinical programs in phases I-II 
• Manage collaborations with CROs and selection of new vendors 
• Communicate data internally and contribute to or author preclinical safety sections of relevant regulatory documentation 
• Ad hoc participation in authority meetings 
• Engaging with the Research team in Denmark and France to ensure adequate species selection and qualification 
• Author high-quality regulatory documents 
• Ensure to be up to date on regulatory toxicology, Immuno toxicity and ensuring compliance with regulatory trends and guidelines 

Your qualifications include several years of experience within toxicology for biologicals from the pharmaceutical/biotechnology industry or a CRO. Experience with both pre-clinical and clinical activities is preferred. It is an advantage if you have experience within the fields of immunology or antibodies. You have worked with CROs and have experience in interaction with regulatory authorities. Experience with pharmacology and interpretation of data. 

You have a Master’s degree in Biology, Human Biology, or another relevant scientific education. A Ph.D. is preferred but not a requirement. 

You are a person with great interpersonal and communications skills and are able to communicate across cultural and functional borders. You work independently and thrive in a cross-functional environment. Finally, you have great project management skills to effectively manage multiple projects simultaneously. 

Symphogen offers a challenging and versatile job in an innovative, flexible, focused, and committed biotech environment. Strong cross-functional teamwork, room for individual performance and development, as well as a great atmosphere with passionate, inspiring, and fun colleagues. A workplace with a focus on social coherence and you as a person. 

Traveling: Approx. 10-20 days per year (mainly to France and CRO visits). 

Domicile: Symphogen’s office in Ballerup.  

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Client Manager Gert Vium Andersen, Unique Human Capital on M: +45 42 95 08 83. All applications must be in English and are treated confidentially.