Your mission

• Supervise CRO activities to ensure bioanalytical method development, validation and sample analysis activities leading to robust methods that support bioanalytical analysis.
• Contribute to method development and qualification of bioanalytical assays and immunoassays for clinical biomarker studies.
• Explore new analytical platforms and lead external vendor setup for biomarkers.
• Graphical representation, interpretation and basic statistical analysis of pharmacokinetic and pharmacodynamic data of preclinical and clinical origin and correlation with biomarkers.
• Write and/or review relevant sections of clinical study protocols, lab manuals, study analysis plans, method development/validation reports.
• Assisting clinical operations team with study sample logistics and sample tracking.
• Develop and maintain collaborative relationship with colleagues within the department, internal stake holders (i.e., Clinical Operations, Pre-Clinical Research) and external vendors.
• Present regular data updates within project team.

Your profile

• M.Sc in Bioanalytical Chemistry, Biochemistry, Biology or related discipline, with a minimum of three years relevant research/industry experience.
• Demonstrated experience in development of bioanalytical assays and interpretation of data is required.
• Understanding in implementation of FDA and EMA bioanalytical guidance in a GxP-like environment.
• Experience in oversight of assay development or transfer as well as validation at multiple CROs is a plus.
• Strong problem solver with excellent interpersonal skills with an ability to collaborate and successfully operate within a high functioning team.
• Proficient with MS Word, MS PowerPoint, and data analysis software (e.g., MS Excel, GraphPad Prism, and/or Discovery Workbench).
• Proactive and hands-on working style
• Fluent in English, German is a plus

Why us?

• Conducting research ultimately relevant for cancer therapies and clinical trials
• Working in an innovative and dynamic environment and being part of a thriving biotech company
• Great working atmosphere within a highly motivated and multicultural team
• Creative working in X-functional teams
• Short communication channels
• Flexible working hours, office and home office based, enable time management on your own terms
• permanent contract

About us

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!