BioNTech IMFS
Select how often (in days) to receive an alert: Associate Director Translational Sciences (Infectious Diseases) Mainz, Germany; London, United Kingdom; Munich, Germany full time Job ID:10683 As a memeber of the cross-functional Translational sub-team you will collaborate with a Translational Lead on the development and implementation of program-specific, integrated biomarker strategies from Ph1 to licensure, in alignment with clinical development objectives. Your main responsibilities are: Contributing to the translation of preclinical results and approaches to clinical biomarker strategies supporting efficient clinical development of the assigned infectious disease assets through data-driven decision making and regulatory compliance Partnering with clinical, technical, and scientific colleagues to contribute to the overall biomarker strategy and assist in its execution Provides biomarker and translational contributions to the integrated development plan, clinical development plan, and to regulatory study- or program-related documents such as clinical trial protocols, and -reports, investigator brochures, briefing documents, and market authorization applications Contributes to the execution of the translational and biomarker strategy in the assigned development program(s) What you have to offer: PhD, PharmD, or MD/PhD in Immunology, Biology, Biochemistry, Molecular Medicine, Virology or a related field with Minimum of 2-3 years of relevant working experience, preferably in industry settings Prior experience in infectious disease research or vaccine development Previous experience working with clinical samples and/or clinical biomarker assay development Experience with development and implementation of relevant biomarker and immunological assays, including ELISpot, ELISAs, flow cytometry, T cell-based assays, serological assays, etc. Demonstrated experience with innovative assay development and proven ability to effectively troubleshoot and solve complex problems. Experience in collaborating with external specialty laboratories is a plus Experience working in a multi-disciplinary team and ability to integrate cross-functional information Scientific accomplishments as evidenced by publications in peer reviewed journals Excellent, broad communication skills in various interpersonal settings Excellent organizational, communication 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) Eagerness to work in the dynamic environment of a fast-growing company Comfortable in working in a matrix environment (global/cross-functional) It's our priority to support you: 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 now - We look forward to your application! Apply to our Mainz, Germany; London, United Kingdom; Munich, Germanylocation by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) -1291 (Monday-Friday from 1 PM to 3 PM CET). Job ID 10683(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. Inspired? Become part of . BioNTech, the story 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, encouragecreativity, 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!
Select how often (in days) to receive an alert: Associate Director Translational Sciences (Infectious Diseases) Mainz, Germany; London, United Kingdom; Munich, Germany full time Job ID:10683 As a memeber of the cross-functional Translational sub-team you will collaborate with a Translational Lead on the development and implementation of program-specific, integrated biomarker strategies from Ph1 to licensure, in alignment with clinical development objectives. Your main responsibilities are: Contributing to the translation of preclinical results and approaches to clinical biomarker strategies supporting efficient clinical development of the assigned infectious disease assets through data-driven decision making and regulatory compliance Partnering with clinical, technical, and scientific colleagues to contribute to the overall biomarker strategy and assist in its execution Provides biomarker and translational contributions to the integrated development plan, clinical development plan, and to regulatory study- or program-related documents such as clinical trial protocols, and -reports, investigator brochures, briefing documents, and market authorization applications Contributes to the execution of the translational and biomarker strategy in the assigned development program(s) What you have to offer: PhD, PharmD, or MD/PhD in Immunology, Biology, Biochemistry, Molecular Medicine, Virology or a related field with Minimum of 2-3 years of relevant working experience, preferably in industry settings Prior experience in infectious disease research or vaccine development Previous experience working with clinical samples and/or clinical biomarker assay development Experience with development and implementation of relevant biomarker and immunological assays, including ELISpot, ELISAs, flow cytometry, T cell-based assays, serological assays, etc. Demonstrated experience with innovative assay development and proven ability to effectively troubleshoot and solve complex problems. Experience in collaborating with external specialty laboratories is a plus Experience working in a multi-disciplinary team and ability to integrate cross-functional information Scientific accomplishments as evidenced by publications in peer reviewed journals Excellent, broad communication skills in various interpersonal settings Excellent organizational, communication 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) Eagerness to work in the dynamic environment of a fast-growing company Comfortable in working in a matrix environment (global/cross-functional) It's our priority to support you: 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 now - We look forward to your application! Apply to our Mainz, Germany; London, United Kingdom; Munich, Germanylocation by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) -1291 (Monday-Friday from 1 PM to 3 PM CET). Job ID 10683(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. Inspired? Become part of . BioNTech, the story 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, encouragecreativity, 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!
BioNTech IMFS
Select how often (in days) to receive an alert: Associate Director Clinical Quality Assurance London, United Kingdom full time Job ID:10151 About the role As an Associate Director Clinical Quality Assurance at BioNTech, you play a pivotal role in ensuring the quality and compliance of our clinical development activities. You will be part of a dynamic, cross functional team that fosters innovation and collaboration while maintaining a proactive, risk based quality strategy. Join us to make an impact in a fast paced environment that values transparency, teamwork, and continuous improvement. Your contribution Establish and implement proactive, risk based Quality Strategies for assigned clinical trials Collaborate with internal stakeholders to identify risks, investigate deviations, and develop robust Corrective and Preventive Actions (CAPAs) with effectiveness checks Maintain inspection readiness through dashboards outlining key quality aspects related to milestones Ensure adequate quality oversight of clinical activities with external partners such as CROs Facilitate Health Authority inspections preparation, support mock inspections, and oversee CAPA completion post inspection Mentor team members while contributing to continuous improvement initiatives within BioNTech A good match University degree in life sciences 5-8 years of experience in a Good Clinical Practice (GCP) regulated environment; 3-5 years in Quality Assurance (QA) Key understanding of global regulations and guidelines such as ICH, FDA, EMA related to clinical trial development Proficiency in managing escalations and CAPA advisement; inspection management experience preferred Strong collaborative skills within cross functional global teams; effective external stakeholder engagement Fluency in English (written and spoken); computer literacy including MS Office and electronic quality management systems BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law. How to apply Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form. Please note: Only applications sent via our online form shall be considered. 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. We are looking forward receiving your application. Inspired? Become part of . BioNTech, the story 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, encouragecreativity, 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!
Select how often (in days) to receive an alert: Associate Director Clinical Quality Assurance London, United Kingdom full time Job ID:10151 About the role As an Associate Director Clinical Quality Assurance at BioNTech, you play a pivotal role in ensuring the quality and compliance of our clinical development activities. You will be part of a dynamic, cross functional team that fosters innovation and collaboration while maintaining a proactive, risk based quality strategy. Join us to make an impact in a fast paced environment that values transparency, teamwork, and continuous improvement. Your contribution Establish and implement proactive, risk based Quality Strategies for assigned clinical trials Collaborate with internal stakeholders to identify risks, investigate deviations, and develop robust Corrective and Preventive Actions (CAPAs) with effectiveness checks Maintain inspection readiness through dashboards outlining key quality aspects related to milestones Ensure adequate quality oversight of clinical activities with external partners such as CROs Facilitate Health Authority inspections preparation, support mock inspections, and oversee CAPA completion post inspection Mentor team members while contributing to continuous improvement initiatives within BioNTech A good match University degree in life sciences 5-8 years of experience in a Good Clinical Practice (GCP) regulated environment; 3-5 years in Quality Assurance (QA) Key understanding of global regulations and guidelines such as ICH, FDA, EMA related to clinical trial development Proficiency in managing escalations and CAPA advisement; inspection management experience preferred Strong collaborative skills within cross functional global teams; effective external stakeholder engagement Fluency in English (written and spoken); computer literacy including MS Office and electronic quality management systems BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate's qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law. How to apply Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form. Please note: Only applications sent via our online form shall be considered. 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. We are looking forward receiving your application. Inspired? Become part of . BioNTech, the story 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, encouragecreativity, 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!