Associate Director, Clinical Pharmacology, Clinical and Quantitative Pharmacology

ModernaMultiple locationsonsiteSalary not postedView the original posting at Moderna ↗

The Role Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna continues to strengthen its research, laboratory, and manufacturing footprint at Harwell, an important hub for our UK scientific and operational activities. Building on our established capabilities, we are focused on advancing mRNA science, enhancing our laboratory and manufacturing operations, and driving continuous improvement across the site. We welcome experts ready to contribute to the continued growth and evolution of Moderna's UK operations. Based within the Clinical Pharmacology group in Moderna’s Clinical and Quantitative Pharmacology (CQP) function, you will bring deep technical, quantitative, and strategic expertise in clinical pharmacology and Model-Informed Drug Development (MIDD) to integrate nonclinical and clinical evidence and shape data-driven development decisions. As an individual contributor, you will represent CQP on program teams and partner closely with Pharmacometrics and Quantitative Systems Pharmacology (QSP) colleagues to develop and execute integrated, model-informed strategies spanning oncology, immunology, and rare disease programs from preclinical development through lifecycle management. Working across Clinical Development, Research, Clinical Safety and Risk Management, Biometrics, Translational Medicine, and Regulatory, you will translate quantitative science into decisions on dose selection, regimen optimization, clinical study design, regulatory strategy, and the continued advancement of Moderna’s mRNA platform and therapeutic pipeline. Here’s What You’ll Do Develop fit-for-purpose Clinical Pharmacology development plans that define the quantitative strategy for programs, including dose selection and optimization, PK/PD 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 PK/PD, characterize key sources of uncertainty, and inform first-in-human dose selection, clinical study design, and IND submissions. Partner closely 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 effectively into program-level decisions. Apply a quantitative and mechanistic understanding of drug disposition, pharmacology, and disease biology to address complex development questions and support dose and regimen optimization, with particular relevance to mRNA therapeutics and other novel modalities. Represent CQP and Clinical Pharmacology on multidisciplinary program teams, bringing together clinical pharmacology, pharmacometrics, translational evidence, safety, biometrics, clinical development, and regulatory perspectives to enable integrated and evidence-based decision-making. Contribute clinical pharmacology expertise to regulatory documentation, including clinical protocols, INDs, regulatory meeting briefing books, summary documents supporting BLAs, and responses to regulatory authorities. Represent Clinical Pharmacology in regulatory interactions, communicating the scientific and quantit

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