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Moderna

Develops mRNA-based medicines for health

Associate Director - Clinical Pharmacology, Clinical and Quantitative Pharmacology

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeOxford, UKNo salary listed

About the Job

Requirements

  • A PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field, and at least 5 years of industry experience in clinical pharmacology, drug metabolism and pharmacokinetics, or Pharmacometrics.
  • Solid understanding and practical application of quantitative pharmacology approaches, including pharmacokinetic/pharmacodynamic modeling, exposure-response analysis, modeling and simulation, and translational pharmacokinetics/pharmacodynamics, with the ability to critically evaluate model assumptions, results, and limitations.
  • Experience integrating nonclinical and clinical evidence to support first-in-human predictions, dose selection, dose optimization, and regulatory decision-making.
  • In-depth knowledge of clinical pharmacology, pharmacokinetic/pharmacodynamic principles, drug disposition, absorption, distribution, metabolism and excretion, and quantitative translational sciences, with the ability to integrate mechanistic understanding and empirical evidence into clinical development strategies.
  • Proficiency in data analysis, data visualization, and relevant pharmacokinetic or modeling software such as R, Phoenix WinNonlin, NONMEM, Monolix, or equivalent tools, with demonstrated ability to apply these tools to real-world development questions.
  • Strong verbal and written communication skills, and the ability to work independently and function in a highly matrixed team environment.
  • The role may require an enhanced pre-employment check as part of Moderna’s workplace safety commitment.

Responsibilities

  • Develop fit-for-purpose clinical pharmacology development plans that define the quantitative strategy for programs, including dose selection and optimization, pharmacokinetic/pharmacodynamic characterization, immunogenicity assessment, pediatric development, and other clinical pharmacology requirements across the development lifecycle.
  • Independently perform and/or critically evaluate quantitative analyses, including pharmacokinetic/pharmacodynamic analyses, exposure-response analyses, and other relevant approaches, translating findings into clear and actionable recommendations for dose selection, regimen optimization, and broader clinical development strategy.
  • Integrate nonclinical, translational, clinical, literature, external, and emerging program data to build a coherent quantitative evidence base that supports scientifically rigorous and efficient development decisions.
  • Work with cross-functional program teams to apply quantitative approaches, including modeling and simulation, to predict human pharmacokinetics/pharmacodynamics, characterize key sources of uncertainty, and inform first-in-human dose selection, clinical study design, and Investigational New Drug submissions.
  • Partner with Pharmacometrics and Quantitative Systems Pharmacology colleagues to identify modeling needs, develop integrated analysis strategies, critically interpret model-based outputs, and ensure quantitative insights are incorporated into program-level decisions.
  • Apply quantitative and mechanistic understanding of drug disposition, pharmacology, and disease biology to address complex development questions and support dose and regimen optimization, particularly for mRNA therapeutics and other novel modalities.
  • Represent Clinical and Quantitative Pharmacology and Clinical Pharmacology on multidisciplinary program teams, integrating clinical pharmacology, pharmacometrics, translational evidence, safety, biometrics, clinical development, and regulatory perspectives to support evidence-based decision-making.
  • Contribute clinical pharmacology expertise to regulatory documentation, including clinical protocols, Investigational New Drug submissions, regulatory meeting briefing books, summary documents supporting Biologics License Applications, and responses to regulatory authorities.
  • Represent Clinical Pharmacology in regulatory interactions and communicate the scientific and quantitative rationale underlying dose selection, clinical pharmacology strategy, and model-informed development decisions.
  • Use scientific literature and collaborate with external institutions to address complex clinical pharmacology and quantitative development challenges, identify innovative analytical approaches, and expand organizational knowledge of the mRNA platform.
  • Contribute quantitative expertise to programs across oncology, immunology, and rare disease from preclinical development through lifecycle management to advance the mRNA platform and therapeutic pipeline.
  • Explore appropriate uses of generative artificial intelligence and other advanced digital tools in clinical pharmacology workflows, including scientific knowledge synthesis, analysis of complex information, analytical workflows, and communicating quantitative insights, while maintaining scientific review and governance.

Desired Qualifications

  • Drug development experience in oncology is strongly preferred; expertise in immune therapeutics and/or rare diseases is a plus.

About the Company

Moderna

Develops mRNA-based medicines for health

Moderna develops medicines built on messenger RNA (mRNA). Its products use mRNA delivered into cells to instruct them to produce specific proteins that can prevent or treat disease, with vaccines being a primary example. In practice, a dose delivers engineered mRNA into the body, cells translate it into a target protein, and the immune system responds or the protein modulates biology to combat disease. Moderna differentiates itself through its focus on building a whole mRNA medicines platform and in-house capabilities for designing, manufacturing, and scaling mRNA therapies, including rapid development and large-scale production. Its goal is to create a new category of medicines based on mRNA that can improve how diseases are discovered, developed, and treated, ultimately improving patient outcomes.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
2010

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