Bioinformatics Team Lead (f/m/d)

• *cecava,** a biopharmaceutical immuno-oncology company based in Tübingen (Germany) currently preparing to conduct first clinical trials, is searching **for an experienced**

# Bioinformatics (f/m/d)

• *in full time**

cecava is developing personalized cancer immunotherapies derived from tumor-specific mutations that give rise to neoepitopes. The successful candidate will guide the bioinformatics team in developing, validating and documenting bioinformatic pipelines in compliance with GxP regulations supporting their full life cycle management and use in early- and late-stage clinical trials.

## Your field of responsibility

• Provide guidance to the bioinformatics team in developing, validating, documenting and refining computational pipelines that support drug design and manufacturing decisions in early- and late-stage clinical trials
• Ensure the full Life Cycle Management of computational pipelines and novel machine learning models is in line with pharmaceutical industry best practice and current US, EU and international guidelines (e.g. FDA 21 CFR Part 11, EU Annex 11, ICH E6, GAMP5)
• Oversee and actively participate in clinical operations of the group, including running pipelines to support ongoing clinical trials
• Support the company in establishing and maintaining a GxP-compliant IT-infrastructure
• Lead and further develop the bioinformatics team – mentoring and supporting the professional development of team members
• Represent the bioinformatics team in cross-functional projects and regulatory interactions

## Our expectations

• Master's or PhD degree in Bioinformatics, Informatics, Computer Science, Computational Biology, or a related field
• At least 3 years of relevant experience working in a regulated environment (preferably GxP) in the pharmaceutical, biotechnology, or a similarly regulated industry.
• Demonstrated experience developing, validating and documenting software for a GxP-regulated environment and according to current regulations (preferably GAMP5)
• Sound knowledge of Software Life-Cycle Management according to pharmaceutical industry best practice and current regulations (including versioning, code review, change & risk management)
• Advanced proficiency in Python and SQL is expected (knowledge in R, Java, or JavaScript is a plus)
• Knowledge in the creation of User Interfaces is a plus
• Ideally, experience in conceptualizing, programming, training and testing of ML models
• Experience with the development of Next-Generation Sequencing analysis pipelines is a plus
• Ideally, a biology background, preferably in oncology, immunology, or immuno-oncology
• Leadership experience, including mentoring, managing and developing bio/informatics teams
• Excellent organizational, communication and presentation skills, including a good working knowledge of German and English (verbally and in writing)
• *Our offer**
• An exciting opportunity to contribute to the development of a disruptive technology for the benefit of cancer patients
• Work within a dedicated team in an entrepreneurial, innovative, and open-minded working atmosphere
• Flat hierarchies and easy access to all company functions
• Free drinks and fresh fruits
• Job bike and Job ticket (Deutschlandticket)

### Your application

Please send your complete application (including cover letter, CV, certificates, expected availability date, salary expectations, a complete list of publications and 2-3 references) by email and in one PDF document to .

• *We look forward to receiving your application**