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 Bio-Analytics (f/m/d)

(Reference No. R2218)

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

Apply now

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)

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).

August 2022