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).
Your mission 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
CDx development:
- 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
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 and related regulatory experience in biotech/ pharmaceutical or in vitro diagnostic industry (oncology focus preferred)
- Understanding of the state-of-the art guidelines for analytical performance evaluation such as CLSI EP series; experience in assay and IVD development and validation in a regulated environment
- Knowledge and understanding of technical platforms including, e.g., (RT-)qPCR, digital PCR, IHC, NGS
- Strongly preferred is experience with device clinical performance study applications, technical documentation/ GSPR compliance
- General understanding of 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
- Excellent communication, writing and presentation skills 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.
- We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to color, national origin, religion, age, marital status, disability, veteran status, romantic orientation, gender identity, or other characteristics protected by law.