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Our client develops innovative therapeutic antibodies in immuno-oncology fighting cancer cells by reactivating the body's own defense mechanisms.
For the next possible date we are looking for a Head of Toxicology to step in a permanent position.
Head of Toxicology (m/w/d)
- 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
Qualifications & Experience
- 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)
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