Director, Quantitative Clinical Pharmacology

About the Role: 

As the Director of Quantitative Clinical Pharmacology, you will play a pivotal role in advancing BioNTech’s innovative drug development pipeline. Your expertise in population pharmacokinetics (PK), exposure-response (ER), and pharmacokinetic/pharmacodynamic (PK/PD) modeling will directly contribute to the development of new treatments for patients worldwide. In this position, you will lead program-level pharmacometrics strategies, foster cross-functional collaboration to drive decision-making, and support regulatory submissions such as IND and NDA/BLA filings. You will also serve as a mentor within the department while shaping best practices in quantitative modeling and analysis. 

Your Contribution:

• Lead hands-on and supervisory population PK, ER, and PK/PD modeling activities using software such as NONMEM, R, Phoenix WinNonlin, or MATLAB


• Drive translational modeling to connect preclinical data with clinical outcomes, supporting dose optimization and go/no-go decisions


• Provide strategic oversight and leadership of external pharmacometrics vendor partnerships, including scope definition, study oversight, quality review, budget management, and delivery of modeling and simulation activities


• Provide quantitative insights for regulatory documents and serve as BioNTech’s representative during Health Authority engagements worldwide


• Influence program strategy through pharmacometric leadership across cross-functional teams


• Recruit, mentor, and develop junior staff while contributing to departmental best practices 

A Good Match: 

• Ph.D., Pharm.D., or M.D. in pharmaceutics, pharmacokinetics, or related fields; M.S. with extensive relevant experience also considered


• Minimum 8 years in biotechnology or pharmaceuticals with hands-on expertise in population PK/PD modeling and regulatory submissions


• Proficiency in NONMEM, R, Phoenix WinNonlin, MATLAB; strong documentation skills for delivering high-quality analyses independently


• Experience overseeing, or other applicable experience with external pharmacometrics vendors and managing modeling and simulation deliverables across multiple programs


• Proven ability to lead matrixed teams effectively; excellent communication skills for conveying complex concepts at all levels


• Experience in oncology; deep understanding of translational research principles