We are currently seeking a (Senior) Manager Companion Diagnostics (Technical Documentation, Performance Studies)* 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).
You will support the Immatics therapeutic pipeline by implementing diagnostic solutions to treat the ‘right’ patient with the ‘right’ drug candidate. This role will involve, but is not limited to the following tasks:
Clinical performance studies under IVDR:
- Establish and/ or 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
- Support implementation of clinical trial assays (CTAs) into clinical drug trials
- Prepare submission documents for device (interventional) clinical performance studies in collaboration with clinical, regulatory, and other functions: Author and/ or review parts of device clinical performance study submission documents (e.g., clinical performance study plan, device investigator brochure), covering technical, IVD risk management, and analytical validation aspects
- Lead and/ or support CDx partner evaluation, technical diligence, and selection activities to establish strategic external CDx partnerships with IVD manufacturers and CROs
- Give input into technical and analytical performance evaluation aspects regarding internal projects and joint projects with CDx partners; may act as project lead for joint projects with CDx partners
- May support and review further regulatory submissions, e.g., pre-submission packages, Investigational Device Exemptions (IDEs), Study Risk Determinations (SRDs), PMA, De Novo, and 510(k) premarket notifications, technical files for CE marking and device-associated parts of drug-related documents
- Help develop the general CDx strategy in a multi-functional team including Immatics’ R&D, clinical, translational, regulatory, commercial, business development, legal, and alliance management functions
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.
*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.
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.