Head Of Bio-analytics

Head Of Bio-analytics

Affimed

Heidelberg, Germany

Responsibilities

  • Lead bio-analytics unit within the company’s Preclinical Development department
  • Drive conceptualization and execution of the bio-analytical strategy for all preclinical & clinical development programs
  • As such drive development of bio-analytical assays (PK, ADA, NAb and biomarker assays) for clinical and non-clinical applications in house or at Contract Research Organizations (CROs); ensure availability of data as required per development plans
  • Ensure transfer of assays to CROs including organization and monitoring of assay development/validation, as well as conduct of bioanalytical studies in collaboration with CROs
  • Ensure regulatory adequacy of bio-analytical program strategies, perform data analysis, drive data-based internal decision making and report results in regulatory documents (e.g. study reports, IND, IB and BLA/MAA)
  • Lead and mentor team members in bio-analytical aspects
  • Act as bio-analytical representative in cross-functional global program teams as required

Requirements

  • Degree in Life Sciences (PhD) with at least 5 years of industrial experience in development of biologics covering the described areas
  • In-depth knowledge in the areas of assays development and validation (Pharmacokinetics, Immunogenicity and Biomarkers) using MSD®, LC-MS/MS and FACS based assays incl. recent and upcoming development of regulatory guidelines
  • Track record of leading conceptualization of bioanalytical program strategies, ideally as line manager
  • Track record of excellence in the area of CRO liaison incl. experience in managing bioanalytical studies according to GLP/GCP
  • 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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