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(Senior) Manager Companion Diagnostics (Assay development)*

Permanent employee, Full-time · Tuebingen, Munich or remote (Germany)
Overview
We are currently seeking a (Senior) Manager Companion Diagnostics (Assay development)* to support our team in the research and development of innovative immunotherapeutic products and diagnostics. The position will be located in Germany (Tübingen, Munich or home-based).
Your mission
You will support the Immatics therapeutic pipeline by implementing diagnostic solutions to treat the ‘right’ patient with the ‘right’ therapeutic candidate. This role will involve, but is not limited to the following tasks:

  • Plan and conduct activities to evaluate feasibility of analytical methods (e.g., IHC) as companion diagnostics (CDx) assays for Immatics’ therapeutic drug candidates and to develop assays with external partners/ diagnostic laboratories
  • Act as project and/ or technical lead for joint projects with diagnostic partners: Oversee planning and execution/ technical aspects of assay development and validation in external collaborations
  • Support biosample sourcing for CDx development and analytical validation projects
  • Lead and/ or support evaluation, selection, and management of clinical trial testing laboratories
  • May lead and/ or support evaluation, selection and contracting of CDx partners - technical diligence and selection activities to establish strategic external CDx partnerships with IVD manufacturers and CROs
  • May support implementation of prospective biomarker testing (patient inclusion assays) into clinical trial documents (e.g., clinical trial protocols)
  • May support and review diagnostic regulatory submissions, e.g., pre-submission packages, device clinical performance study submissions under IVDR, Investigational Device Exemptions (IDEs), Study Risk Determinations (SRDs), PMA, De Novo, and 510(k) marketing applications and technical files for CE marking
  • Help develop the general CDx strategy in a multi-functional team including Immatics’ R&D, clinical, translational, regulatory, commercial, business development, and legal functions
Your profile
  • Advanced degree in Life Sciences, Biochemistry, Molecular Biology, Molecular Medicine or comparable field; PhD or MS with 3-5 years of relevant experience, including CDx/ IVD assay development experience in biotech/ pharmaceutical or in vitro diagnostic industry (oncology focus preferred)
  • Understanding of the guidelines for assay analytical validation, experience in assay and IVD development and validation in a regulated environment
  • Knowledge and understanding of technical platforms including, e.g., IHC, (RT-) qPCR, sequencing technologies (NGS)
  • General understanding of the current US/ EU regulatory requirements for IVD/ CDx development and approval
  • Familiarity with IVD design control requirements and product development process is preferred  
  • 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
  • Excellent communication and presentation skills (written and verbal) in English (German is a plus)
  • Strong motivation to bring innovative diagnostic solutions to the clinic
Why us?
We are a committed and inspired team and cherish the collegial, highly motivated, and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits – e.g., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.
Notice
*We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
About Us
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets.

This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
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