(Senior) Manager Companion Diagnostics*

Overview

We are currently seeking a (Senior) Manager Companion Diagnostics* to support our team in the research and development of innovative immunotherapeutic products and diagnostics. You will work in Tübingen, Munich or Germany home-based in an interdisciplinary environment with colleagues and external partners from Germany and the United States.

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:

• Act as project and technical lead in joint projects with external diagnostic partners for clinical trial assay and/ or CDx assay development and validation 
• Give input into technical and analytical performance evaluation aspects regarding internal and joint projects with CDx partners and support the establishment of design control
• Establish and review documentation required for EU IVDR compliance of analytical assays developed by Immatics for patient inclusion into clinical trials (e.g., technical documentation), in collaboration with the internal team and external consultants
• Lead and support CDx partner evaluation, technical diligence, selection activities and contracting, to establish strategic external CDx partnerships with IVD manufacturers and clinical laboratories, e.g., Contract Research Organizations (CROs)
• Support the biosample sourcing for CDx development and analytical validation projects
• May support the 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., Investigational Device Exemptions (IDEs), HDEs, PMAs, De Novos, and 510(k) marketing applications, technical files and regulatory risk files for CE marking, and others
• Help to develop the general CDx strategy in a multi-functional team including Immatics R&D, clinical,   regulatory, and other functions

Your profile

• M.Sc. or PhD in Life Sciences, Biochemistry, Molecular Biology, Molecular Medicine or a comparable field, plus 3-5 years of relevant experience
• CDx/ IVD assay development experience in the biotech/ pharmaceutical or the 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
• Familiarity with IVD design control requirements, risk management, and product development process preferred
• Knowledge and understanding of technical platforms including, e.g., (RT)-qPCR, digital PCR, IHC
• General understanding of the current US/ EU regulatory requirements for IVD/ CDx development and approval
• 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, as well as technical writing skills
• 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.