PBPK Modeler as Associate Director DMPK

At BioNTech, you will contribute to non-clinical development and safety activities for global R&D programs and new technology platforms during different stages of pharmaceutical development by providing expertise in preclinical quantitative modeling and drug metabolism and pharmacokinetics (DMPK). BioNTech is expanding its activities towards new therapeutic modalities in different disease areas. You will serve an important role by implementing model-informed drug discovery and development to a range of modalities, including mRNA therapeutics, biologics, and ADCs to facilitate the clinical translation of our first-in-class immunotherapeutics and vaccines. Your duties in detail:

Task

• Serve as the PBPK modeling representative on multiple cross-functional project teams in oncology and infectious disease, planning and implementing PK strategies according to project plans and incorporate quantitative methodologies into drug development.
• Independently develop and perform PBPK and QSP modeling and simulation to enhance decision-making for candidate selections and inform translational research strategies.
• Apply modeling and simulation to predict human PK, determine efficacious dose/dose regimen, guide selection of first-in-human starting dose and author corresponding report for regulatory submission.
• Present quantitative data and promote model-based decision-making within project teams and to external collaborators.
• Engage with CROs and external consultants regarding conduct and interpretation of non-clinical PK studies.
• Author, contribute, and review relevant regulatory documents such as IND, IBs, CTAs, etc. for regulatory submissions.
• Collaborate in cross-functional teams with preclinical pharmacology, medicinal/peptide chemistry, bioanalytics, clinical pharmacology, and others to execute project specific deliverables.

What you have to offer

• Degree in pharmacokinetics/pharmacodynamics, pharmacometrics, biology, mathematics, chemical/biomedical engineering or related field. Preferably advanced degree incl. PhD/MD/VMD
• Several years of experience in the biotechnology or pharmaceutical industry including strong theoretical and practical knowledge of PK, PK/PD, PBPK and QSP modeling.

• Strong research background with interest in translating data into insights and recommendations.
• Good understanding of ADME characterization of large and small molecules and experience to serve as DMPK representative in project teams is a plus.
• Excellent communication and interpersonal skills and ability to work in highly matrixed environments.
• Proficient in using software for PBPK modelling (e.g. PK-Sim, Simcyp, Gastro Plus) and/or for QSP modeling (Matlab, R, etc). Familiarity with other software like Phoenix , Monolix, or NONMEN is highly desirable.

Your Benefits:

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• 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 mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!

Apply to our Mainz, Germany; London, United Kingdom; Munich, Germany 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 9573 (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.