Working @ Immatics

Senior Manager Clinical Biomarkers/ Companion Diagnostics*

Permanent employee, Full-time · Tuebingen, Munich or remote (Germany)

Overview
We are currently seeking a Senior Manager Clinical Biomarkers/ Companion Diagnostics* to support our team in the research and development of innovative immunotherapeutic products and diagnostics. The position can be located in Tübingen, Munich or home based (Germany).
Your mission
You will support the Immatics therapeutic pipeline by implementing diagnostic solutions to treat the right patient with the right medicine. This role will involve, but is not limited to the following tasks:
 
  • Contribute to clinical trial design and set-up by implementing prospective biomarker testing (patient inclusion assays) into clinical trial protocols; author CDx portions of briefing documents, schedule of activities, IND/ IMPD, informed consent forms, laboratory manuals; support submissions to regulatory agencies (e.g., FDA, PEI) and ethics committees.
  • Collaborate with Clinical Operations and Sample Management to manage CDx operations in clinical trials – e.g. regarding sample journey, relevant documentation and biomarker/ CDx analyses in compliance with appropriate regulatory requirements.
  • Function as Subject Matter Expert on questions from clinical trial sites or regulatory institutions on sample collection from patients and regarding biomarker analyses.
  • May perform or support selection and vendor management of external CROs involved in biomarker testing in clinical trials.
  • Support strategic external CDx partnerships with IVD manufacturers and CROs, e.g., respond to inquiries on biospecimens and manage biospecimen transfers, contribute to diagnostic clinical study plans and reports, provide requested information to diagnostic companies to support CDx clinical validation studies.
  • Contribute to the general CDx strategy in a multi-functional team including Immatics’ R&D, clinical, translational, regulatory, commercial, business development, legal, and alliance management functions.
Your profile
  • Advanced degree in Life Sciences, Biochemistry, Molecular Biology, Molecular Medicine or comparable field; either PhD with 3-5 years or MS with 5+ years of experience in the biotech/ pharmaceutical or the in vitro diagnostic industry, or in an academic environment (oncology focus preferred).
  • Strong experience in design and execution of clinical trials, and/ or in implementing biomarker testing into clinical trials.
  • Experience in regulatory submission processes and understanding of requirements of drug and/ or medical device clinical trials.
  • Experience in technical platforms including qPCR and sequencing technologies/ NGS technologies. Preferred in addition are IHC and liquid biopsy analyses, and experience in IVD validation.
  • Understanding of operational and regulatory considerations for CDx strategies in clinical development.
  • Knowledge in GCP and GLP. Familiarity with CLIA, CAP, ISO15189, ISO13485, IVDR, and FDA QSR regulations is a plus.
  • Preferably experience in medical oncology/ immune oncology.
  • Strong project management and organization skills to manage and timely complete deliverables.
  • Highly motivated team player with strong interpersonal skills.
  • Proven scientific excellence and ability to evaluate, interpret and present complex scientific data.
  • Excellent communication and presentation skills (written and verbal) in German and English.
  • Strong motivation to bring innovative diagnostic solutions to the clinic.
  • High level of business awareness.
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.