Jobs · Information Technology · Pennsylvania

Principal PK/PD Scientist – Respiratory

Barrington James · Greater Harrisburg Area · 1 wk ago
Information TechnologyFull-time

Key Responsibilities

  • Lead the design, development, and application of PK/PD and pharmacometric analyses across respiratory assets.
  • Develop and implement model-informed drug development (MIDD) strategies to support clinical development and regulatory decision-making.
  • Conduct and oversee population PK, exposure-response, dose optimization, and simulation analyses.
  • Collaborate closely with Clinical Pharmacology, Translational Medicine, Clinical Development, Biostatistics, Regulatory Affairs, and other cross-functional teams.
  • Provide quantitative insights that shape program strategy and portfolio decisions.
  • Contribute to regulatory submissions, briefing documents, and interactions with global health authorities.
  • Drive scientific innovation through the application of advanced modelling and simulation techniques.
  • Mentor junior scientists and contribute to the development of quantitative sciences capabilities across the organization.

What you'll need

  • Significant pharmaceutical, biotechnology, or CRO industry experience.
  • Extensive expertise in PK/PD modelling, population pharmacokinetics, exposure-response analysis, and model-informed drug development.
  • Strong respiratory therapeutic area experience, including asthma, COPD, severe asthma, pulmonary fibrosis, chronic cough, or related respiratory indications.
  • Advanced proficiency with NONMEM, Monolix, R, Phoenix NLME, or equivalent pharmacometric software.
  • Demonstrated ability to influence development strategy and communicate complex quantitative findings to senior stakeholders.
  • Experience supporting multidisciplinary global development teams.

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