Director* Translational Sciences (Oncology) in Mainz bei BioNTech AG

Open for hire at one of the following locations – Mainz Goldgrube. - Job ID: 7493

Join our team of pioneers!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

• With deep knowledge and extensive oncology experience, you will drive the translational strategies for the clinical development of oncology programs
• Provide cross-functional leadership to establish an integrated view of respective translational functions and expertise
• As a Translational Medicine leader, develop and execute the biomarker strategies from Ph1 to licensure in alignment with BioNTech clinical development objectives
• Bridge preclinical experimental data to translational strategies in assigned programs to deeply integrate the mechanism of action into the clinical development plan (target engagement, pharmacodynamics endpoints, patient selection) and correlate with clinical outcomes
• The role will provide scientific, technological, strategic guidance, and hands-on contributions to biomarker programs accompanying clinical trials to drive the company´s R&D programs, including CDx development
• The role will coordinate biomarker-related program activities with internal and external stakeholders and drive integration of services, technologies, and capabilities to ensure achievement of program goals
• Provide state-of-the-art biomarker input in regulatory documents (clinical study reports, IND, BLA documentation) Analyze, interpret, and present clinical biomarker data to draw scientifically valid conclusions that support and enable decision-making
• The role works with cross-functional teams (clinical, regulatory, diagnostics, preclinical) to ensure the key definitions in clinical translational steps agree with clinical development and regulatory approvals
• The role is accountable for strengthening the interfaces, processes, and approaches across functions and teams within BioNTech and strives for continuous improvement and acceleration

• Ph.D. or PhD/MD in immunology, molecular biology, or related discipline with a scientific background in oncology or immuno-oncology
• 6 to 10+ years of clinical development experience as biomarker project lead in the biotech/pharmaceutical industry
• Therapeutic knowledge and scientific accomplishments as evidenced by publications in peer-reviewed journals in oncology or immuno-oncology
• In-depth understanding of translational medicine and biomarker mechanisms associated with immuno-oncology and targeted therapies
• Demonstrated managerial experience in the biopharmaceutical industry
• Demonstrated experience with innovative assay development and proven ability to troubleshoot and solve complex problems effectively and experience in collaborating with external specialty laboratories
• Experience in working within interdisciplinary cross-functional teams with other key development functions (clinical lead, regulatory, biostatistics, operations, and clinical pharmacology) to develop and execute the biomarker strategy in alignment with clinical development objectives
• Ability to independently drive, manage, execute, and deliver results for a number of complex multi-functional projects