Director, Quantitative Clinical Pharmacology (Remote)
BioNTech
Summary
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.
Job description
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
Requirements
- 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 working 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
Benefits
- Annual Bonus
- Equity
- Competitive Remuneration
Company overview
BioNTech SE is a pioneering German multinational biotechnology company headquartered in Mainz, Germany, that specializes in developing innovative immunotherapies and vaccines for cancer and infectious diseases. Founded in 2008 by scientists Uğur Şahin, Özlem Türeci, and Christoph Huber, the company gained global recognition for co-developing the first approved mRNA-based COVID-19 vaccine with Pfizer. BioNTech's core expertise lies in mRNA technology, which it has been researching for over 15 years, with applications spanning individualized cancer medicine, infectious disease prevention, and novel therapeutic approaches. The company operates a diversified portfolio including mRNA cancer immunotherapies, next-generation immunomodulators, targeted therapies, and antibody-drug conjugates. With approximately 6,800 employees across more than 20 global sites, BioNTech maintains a strong focus on oncology, advancing multiple late-stage clinical programs while expanding its infectious disease pipeline to address conditions like malaria, tuberculosis, and mpox. The company's strategic acquisitions, including InstaDeep for AI capabilities and CureVac for mRNA expertise, further strengthen its position as a leader in next-generation biopharmaceutical innovation.