Associate Director, Clinical Pharmacology
BioNTech SE
September 02, 2026
On-site
Cambridge, MA
Clinical Research and Development
Your Contribution:
- Lead the analysis, interpretation, and reporting of clinical pharmacokinetic data.
- Drive PK/PD modeling, exposure-response analyses, and translational quantitative pharmacology to support optimal dose and dose selection decisions.
- Plan, design, execute, and report clinical pharmacology studies (e.g., QT assessments, food effect studies, ADME investigations, DDI strategies) with cross-functional teams to support drug development and rapid product registration.
- Collaborate with research leads on study design and data interpretation of PK, toxicokinetic, and PD aspects of preclinical studies.
- Provide clinical pharmacology and pharmacometrics input into regulatory documents (e.g., IBs, briefing books, NDA/BLA submissions).
- Represent BioNTech at global health authority meetings with clinical pharmacology and pharmacometrics expertise.
A Good Match:
- Ph.D., MD, or Pharm.D. in pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics, or related discipline.
- Minimum 5 years of clinical pharmacology experience in biotechnology or pharmaceutical industry.
- Proven track record leading drug development programs from early exploratory studies through Phase 2/3 trials.
- Expertise in translational research or pharmacometrics for oncology or infectious disease drug development.
- Proficiency with Phoenix WinNonlin, R, NONMEM, and/or MATLAB.
- Strong communication/presentation skills; ability to lead cross-functional teams in a matrix environment.
- Self-motivated, collaborative, and innovation-focused.
Application Instructions:
- Apply for the Cambridge, US; Gaithersburg, US; New Jersey, US location and submit documents using the online form.
- Lead the analysis, interpretation, and reporting of clinical pharmacokinetic data.
- Drive PK/PD modeling, exposure-response analyses, and translational quantitative pharmacology to support optimal dose and dose selection decisions.
- Plan, design, execute, and report clinical pharmacology studies (e.g., QT assessments, food effect studies, ADME investigations, DDI strategies) with cross-functional teams to support drug development and rapid product registration.
- Collaborate with research leads on study design and data interpretation of PK, toxicokinetic, and PD aspects of preclinical studies.
- Provide clinical pharmacology and pharmacometrics input into regulatory documents (e.g., IBs, briefing books, NDA/BLA submissions).
- Represent BioNTech at global health authority meetings with clinical pharmacology and pharmacometrics expertise.
A Good Match:
- Ph.D., MD, or Pharm.D. in pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics, or related discipline.
- Minimum 5 years of clinical pharmacology experience in biotechnology or pharmaceutical industry.
- Proven track record leading drug development programs from early exploratory studies through Phase 2/3 trials.
- Expertise in translational research or pharmacometrics for oncology or infectious disease drug development.
- Proficiency with Phoenix WinNonlin, R, NONMEM, and/or MATLAB.
- Strong communication/presentation skills; ability to lead cross-functional teams in a matrix environment.
- Self-motivated, collaborative, and innovation-focused.
Application Instructions:
- Apply for the Cambridge, US; Gaithersburg, US; New Jersey, US location and submit documents using the online form.