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. You will work in Tübingen or Munich (Germany) or home based.
(all genders welcome)
Your main responsibilities will include but are not limited to the following tasks:
- Contribute to general companion diagnostics (CDx) strategy (HLA typing, target expression) in a multi-functional team including Immatics’ R&D, clinical, translational, regulatory, commercial, business development and alliance management functions.
- Help establish strategic external CDx partnerships with IVD manufacturers and CROs.
- May develop into a project lead for joint projects with CDx partners: oversee technical aspects of assay development and validation, clinical implementation of the assay, and data analysis; organize meetings (internal and with partners); assess timely delivery and quality of milestones as per the agreed project scope and budget.
- Evaluate technologies and assays regarding their scientific basis, clinical applicability and validation status for clinical biomarker and CDx development.
- Contribute to submissions to regulatory agencies: Author CDx chapters of clinical protocols, clinical study reports, informed consents; support submissions to regulatory agencies like FDA and PEI (e.g. IDE, PMA, CE mark).
- Collaborate with Clinical Operations and Sample Management to coordinate biomarker/ CDx analyses for clinical trials.
- Participate in implementation and further development of innovative biomarker/ CDx assays (in-house and with partners).
- Advanced degree in Life Sciences, Biochemistry, Molecular Biology, Biotechnology, Pharmacy or comparable field; either PhD with 3-5 years or Master’s Degree with 5+ years of experience in the biotech/ pharmaceutical or diagnostic industry, or in an academic laboratory environment.
- Experience in analytical assay development, optimization and validation, and/ or oncology, immunology, or cancer immunology.
- Experience in molecular biology techniques: Sequencing technologies, understanding of NGS including knowledge of available platforms and target enrichment methodologies; HLA typing; qPCR. In addition, experience with IHC/ ISH, liquid biopsy analyses, and/ or immunoassays would be preferred.
- Ideally experience in biomarker testing and CDx assay development and validation in the framework of clinical trials, understanding of regulatory aspects (such as IVD design control/ FDA-QSR, CLIA, CAP, ISO regulations) and of the needs of pharma and diagnostic partners to ensure successful project execution and product launch.
- 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.
- Intermediate to advanced level experience with MS Office products (Word, Excel, PowerPoint, SharePoint).
We expect a high degree of independent working, analytical reasoning and excellent communication and presentation skills in English, German is a plus. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. You approach tasks in a structured, reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills.
What we offer
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.
If you’re interested in working for Immatics, please apply online and provide your application documents along with the relevant credentials and certificates. Mrs Annemarie Selbenbacher will answer initial questions at +49 89 125 03 98 33 (landline number Germany). Coredi Recruiting GmbH (Mrs Annemarie Selbenbacher) advises Immatics on this job posting.