Director, Quantitative Clinical Pharmacology

Locations: Cambridge, US; Gaithersburg, US; New Jersey, US. Full‑time.

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.

Responsibilities

• 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.

Qualifications

• 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 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 and deep understanding of translational research principles.

Pay

The Expected Pay Range is $168,100 / year to $268,700 / year plus benefits, annual bonus & equity (bonus and equity are variable and dependent on company and individual performance). Compensation depends on responsibilities, education, experience, knowledge, skills, and abilities. Compensation at other locations may vary significantly.

Benefits

BioNTech is committed to the wellbeing of its team members and offers a variety of benefits in support of a diverse employee base. Benefits may vary by location and are subject to internal policies and applicable law.