Preclinical Project Manager Position (m/f/d)

University Hospital of Würzburg

Preclinical Project Manager Position (m/f/d)

University Hospital Würzburg

Home Based or Würzburg, Germany

The Hemibody Lab at the University Hospital Würzburg/Germany (Department of Medicine II; Chair: Prof. Dr. Hermann Einsele) is inviting applications for a Preclinical Project Manager Position (m/f/d).

We are looking for a Project Manager with detailed work background in preclinical antibody drug development. You must have knowledge and experience working with the German regulatory Paul-Ehrlich Institute (PEI).

The position can be performed from any city in Germany. It is not mandatory to relocate to Würzburg.

Our group developed novel Split T cell engaging Antibodies, so called Hemibodies, which redirect immune cells against Multiple Myeloma cancer cells. For the Myeloma-Hemibodies, the cell line development and pre-GMP production has already started. We plan to start the GMP production within the next 12 months.

Your challenge:

  • To set up and lead the planning and execution of the Hemibody drug development program;
  • This work includes the necessary paperwork for the PEI and EMA;
  • You will assess the requirements for animal studies according to guidelines and 3R principles using a step-wise approach (in silico knowledge-based, in vitro, in vivo);
  • You will provide pharmacology expertise for in vitro and in vivo functional characterization and bioassay strategies and ensure an integrated assessment of nonclinical in vitro bioassay data;
  • You will assure the quality of the pre-clinical studies and study results according to the appropriate regulatory guidelines. You will work on the Target product profile (TPP) all the way through to the drug development program;
  • The candidate will be able to work on a high-impact project designed for a first period till December 2021, with the possibility of a permanent contract for the following period.

Your profile:

  • Applicants for this position must have solid experience in antibody drug development;
  • You must have worked with the Paul-Ehrlich Institute (PEI) and the European Medicines Agency (EMA) before;
  • You will have expert knowledge of the current literature, of the regulatory guidelines for antibody drug development, of the concepts and controversies in nonclinical pharmacology and safety;
  • You will have experience with translational pharmacology and research.

Your team:

Our lab and department provides a stimulating and nurturing environment with a team of experienced, driven scientists.

The Department of Medicine at the University Hospital Würzburg runs one of the largest early clinical trial units in Germany, which provides numerous opportunities for clinical translation.

Disabled applicants will be preferentially considered in case of equivalent qualifications.

Application:

Please send a letter of motivation (German or English) and your CV as a single combined pdf-file to: Dr. Thomas Bumm, bumm_t@ukw.de.

Don't forget to mention EuroPharmaJobs when applying.

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© EuroJobsites 2020

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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