Lead toxicology unit within the company’s Preclinical Development department reporting to the VP Preclinical Development;
Drive development and implementation of project plans regarding non-clinical safety for all preclinical and clinical development programs;
Organize and monitor toxicological studies in collaboration with Contract Research Organizations (CROs);
Work in close contact with bio-analytical unit to ensure timely availability of adequate methods to support animal studies;
Perform data analysis, review and compile study reports for internal decision making and reflect results in regulatory documents (e.g. IND, IB and BLA/MAA);
Instruct and mentor team members in non-clinical safety aspects;
Act as toxicology expert in cross-functional global program teams as required.
Degree in Life Sciences (PhD/MD/VMD) with at least 5 years industrial experience in the described fields, preferably 3+ years industry experience in development of biologics, Qualification as board certified toxicologist (e.g. DGPT, ERT, DABT) is a plus;
Demonstrated knowledge of biologics drug development and immunotherapy or oncology;
In-depth knowledge in the areas of Toxicology, Pharmacokinetics, and Immunogenicity incl. recent and upcoming development of regulatory guidelines;
Track record of excellence in the area of CRO liaison incl. experience in managing animal studies according to GLP;
Experience in regulatory agency interactions, e.g. Pre-INDs, INDs or market authorizations;
Ability to conduct multiple projects delivering agreed milestones adhering to timelines and budget;
Ability to work in interdisciplinary development teams incl. excellent communication skills and fluency in English (oral and written).