Associate Director, Clinical Pharmacology, Clinical and Quantitative Pharmacology

Job description

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 quantitative rationale underpinning dose selection, clinical pharmacology strategy, and model-informed development decisions. Leverage 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 significantly to advancing Moderna’s mRNA platform and therapeutic pipeline by bringing rigorous quantitative thinking to programs across oncology, immunology, and rare disease from preclinical development through lifecycle management. Explore appropriate opportunities to use Generative AI and other advanced digital tools within the clinical pharmacology workflow—for example, to accelerate scientific knowledge synthesis, interrogate complex information, support analytical workflows, and improve the efficiency with which quantitative insights are generated and communicated—while maintaining appropriate scientific review and governance. The key Moderna Mindsets you’ll need to succeed in the role: “We act with dynamic range, driving strategy and execution at the same time at every step.” “We digitize everywhere possible using the power of code to maximize our impact on patients.” Here’s What You’ll Need (Basic Qualifications) PhD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 5 years of industry experience in clinical pharmacology/DMPK/Pharmacometrics Solid understanding and practical application of quantitative pharmacology approaches, including PK/PD modeling, exposure-response analysis, modeling and simulation, and translational PK/PD, with the ability to critically evaluate model assumptions, results, and limitations. Drug development experience in oncology is strongly preferred; expertise in immune therapeutics and/or rare diseases is a plus. 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, PK/PD principles, drug disposition, ADME, and quantitative translational sciences, with the ability to integrate mechanistic understanding and empirical evidence into clinical development strategies. Proficiency in data analysis, visualization, and relevant pharmacokinetic or modeling software (e.g., 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 ability to work independently and function in a highly matrixed team environment. As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being with access to fitness, mindfulness, and mental health support Family building benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and i