Associate Director, Clinical Pharmacology
BioNTech SE
September 23, 2026
Full-time
Remote friendly (Cambridge, MA)
Worldwide
Clinical Research and Development
Role: Associate Director, Clinical Pharmacology & Pharmacometrics, leading the design and execution of clinical PK/PD studies to support drug development in oncology and infectious diseases. Responsibilities: analyze PK data, drive PKPD modeling, conduct translational pharmacology activities, design studies (e.g., QT, DDI, ADME), and contribute to regulatory submissions (INDs, NDAs/BLA). Collaborate across teams on preclinical and clinical data interpretation, provide expert input for regulatory documents, and represent the company in global health authority meetings. Requirements: Ph.D., MD, or Pharm.D. with at least 5 years in clinical pharmacology within biotech/pharma, proven experience in oncology/infectious disease drug development, and proficiency with modeling tools such as NONMEM, Phoenix WinNonlin, R, or MATLAB. Preferred: expertise in translational research, strong communication skills, and leadership in cross-functional teams. HighValue: oncology and infectious diseases, early to late-stage clinical studies (Phase 1-3), translational pharmacology, regulatory interactions, and global collaboration. WorkSetup: locations in Cambridge, MA; Gaithersburg, MD; or NJ, US, with unspecified travel expectations.