Director Translational Sciences – Oncology

Role Overview

• Responsible for the development, implementation and execution of the biomarker strategy from early Ph1 to licensure, in alignment with clinical development objectives.
• Drive the translational strategies for clinical development of oncology programs based on an integrated view of the respective translational expert functions
• Responsible for bridging preclinical experimental data to translational strategies in the assigned programs to deeply integrate the mechanism of action to the clinical development plan (target engagement, pharmacodynamics endpoints, patient selection) and correlate with clinical outcomes
• Provide scientific, technologic and strategic guidance and hands-on contribution to biomarker programs accompanying clinical trials to drive the company´s R&D programs; experience in CDx development is a plus
• Coordinate biomarker related program activities with internal and external stakeholders and driving integration of services, technologies, and capabilities to ensure reaching of program goals
• Provide state of the art biomarker input in regulatory documents (clinical study reports, IND, BLA documentation)
• Analyzes, interprets and presents clinical biomarker data and draws scientifically valid conclusions that support and enable decision making
• Work with a cross-functional team (clinical team, regulatory, diagnostics, preclinical) to ensure the key definitions in clinical translational steps are in agreement with clinical development and regulatory approvals
• Accountable to strengthen the interfaces, processes and approaches across functions and teams within BioNTech, and strives for continuous improvement and acceleration

Requirements

• Ph.D. or PhD/MD in Immunology, molecular biology, pathology or related discipline with scientific background in Oncology or Immuno-Oncology
• 6 to 10+ years of oncology clinical development experience as biomarker project/program lead in the biotech/pharmaceutical industry
• Therapeutic knowledge and scientific accomplishments as evidenced by publications in peer reviewed journals in oncology or immune-oncology
• In depth understanding of translational medicine and biomarker mechanisms associated with immune-oncology and targeted therapies.
• Demonstrated experience with innovative assay development and proven ability to effectively troubleshoot and solve complex problems, 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 portfolio of complex multi-functional projects
• Eagerness to work in the dynamic environment of a fast-growing company and comfortable in working in a matrix environment (global/cross-functional)
• A genuine interest and understanding of the science supporting the development programs
• Excellent, broad communication skills in various interpersonal settings as well as excellent organization skills and attention to details
• Strong writing skills as demonstrated by authorship of peer-reviewed publications and contributions to regulatory communications (e.g., briefing documents, clinical trial protocols, marketing authorization applications)

Benefits

• flexible hours
• vacation account
• Digital Learning
• Performance & talent development
• leadership development
• Apprenticeships
• LinkedIn Learning
• Your voice at the table
• Culture on an equal footing
• Opportunities to shape & impact
• Support for your full potential
• Company bike
• Job ticket
• Deutschlandticket
• Employer-funded pension
• Childcare