Head of Toxicology

Head of Toxicology

Affimed

Heidelberg, Germany

Responsibilities

  • 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.

Requirements

  • 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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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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