Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company which engineers targeted immunotherapies, seeking to improve patient outcomes through the power of innate immunity. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. We are developing single and combination therapies to treat cancers.

To strengthen our highly motivated Research & Development Team in Heidelberg, Germany, we are looking for a

Head of Toxicology & Bio-Analytics (f/m/d)

(Reference No. R2211)

to support preclinical development of novel biologics in immuno-oncology.

Apply now

Responsibilities

  • Lead toxicology and bio-analytics unit within the company’s Preclinical Development department reporting to the head of Preclinical Development
  • Drive development and implementation of project plans regarding non-clinical safety and bio-analytical strategy (pharmacokinetics and immunogenicity) for all preclinical & clinical development programs at Affimed AG
  • Organize and monitor toxicological studies in collaboration with Contract Research Organizations (CROs)
  • Develop bio-analytical assays for clinical and non-clinical applications in house or at CROs. Transfer assays to CROs as needed and ensure availability of adequate assays as required per development plan
  • Perform data analysis and compile toxicological findings and bio-analytical 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 and bio-analytical aspects
  • Act as toxicology and bio-analytical representative 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)

Opportunity

The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary, and collegial team incl. a flexibility for home office solutions.
For any queries, please contact Susanne Hering (Tel: 06221 6743 675, e-mail: s.hering@affimed.com).

May 2022

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