Director, Quantitative Clinical Pharmacology

BioNTech•Berkeley Heights, NJ
•$168,100 - $268,700•Onsite

About The Position

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.

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 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

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

Benefits

  • competitive remuneration packages
  • annual bonus & equity
  • benefits

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What This Job Offers

Job Type

Full-time

Career Level

Director

Education Level

Ph.D. or professional degree

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