Online Laboratory Magazine

Senior Manager Clinical Biomarkers / Companion Diagnostics (m/f/d)

  • Advanced degree in Life Sciences, Biochemistry, Molecular Biology, Biotechnology, Pharmacy or comparable field - either PhD with 3-5 years or Master's Degree with 5+ years of experience in the biotech / pharmaceutical or diagnostic industry or in an academic laboratory environment
  • Experience in analytical assay development, optimization and validation and / or oncology, immunology or cancer immunology
  • Experience in molecular biology techniques: Sequencing technologies, understanding of NGS including knowledge of available platforms and target enrichment methodologies; HLA typing; qPCR, in addition, experience with IHC / ISH, liquid biopsy analyses and / or immunoassays would be preferred
  • Ideally experience in biomarker testing and CDx assay development and validation in the framework of clinical trials, understanding of regulatory aspects (such as IVD design control / FDA-QSR, CLIA, CAP, ISO regulations) and of the needs of pharma and diagnostic partners to ensure successful project execution and product launch
  • Strong project management and organization skills to manage and timely complete deliverables
  • Proven scientific excellence and ability to evaluate, interpret and present complex scientific data
  • Intermediate to advanced level experience with MS Office products (Word, Excel, PowerPoint, SharePoint)
  • Contribute to general companion diagnostics (CDx) strategy (HLA typing, target expression) in a multi-functional team including Immatics' R&D, clinical, translational, regulatory, commercial, business development and alliance management functions
  • Help establish strategic external CDx partnerships with IVD manufacturers and CROs
  • May develop into a project lead for joint projects with CDx partners: oversee technical aspects of assay development and validation, clinical implementation of the assay and data analysis; organize meetings (internal and with partners); assess timely delivery and quality of milestones as per the agreed project scope and budget
  • Evaluate technologies and assays regarding their scientific basis, clinical applicability and validation status for clinical biomarker and CDx development
  • Contribute to submissions to regulatory agencies: Author CDx chapters of clinical protocols, clinical study reports, informed consents; support submissions to regulatory agencies like FDA and PEI (e.g. IDE, PMA, CE mark)
  • Collaborate with Clinical Operations and Sample Management to coordinate biomarker / CDx analyses for clinical trials
  • Participate in implementation and further development of innovative biomarker / CDx assays (in-house and with partners)

» Job description

immatics biotechnologies GmbH
Tübingen or Munich