Quality Control jobs in United Kingdom

Mainz, Germany; London, United Kingdom | full time | Job ID:9929

As a recognized leader in Translational Medicine, the role will be responsible for the development, implementation and execution of the biomarker strategy from early Ph1 to licensure, in alignment with clinical development objectives.

• Based on deep knowledge of and extensive experience with oncology, the role will 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
• The role will provide scientific, technological 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
• The role will coordinate biomarker related program activities with internal and external stakeholders and drive integration of services, technologies, and capabilities to ensure reaching of program goals
• The role will provide state of the art biomarker input in regulatory documents (clinical study reports, IND, BLA documentation)
• The role analyzes, interprets and presents clinical biomarker data and draws scientifically valid conclusions that support and enable decision making
• The role will 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
• The role is accountable to strengthen 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, 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)

• Your flexibility: flexible hours | vacation account
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your life phases: Employer‑funded pension | Childcare

Apply to our Mainz, Germany; London, United Kingdom location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday‑Friday from 12 PM to 4 PM CET).

Job ID 9929 (please always specify if you have any questions)

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech‑Recruiter.

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting‑edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!