• Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development) • Provide functional representation on development programs and study teams and identify opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety • Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical) • Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies • Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results • Conduct hands-on quantitative analysis and present the findings to multidisciplinary project teams • Serve as lead author and key contributor to clinical pharmacology sections of documents • Serve as the subject matter expert in interactions with Health Authorities • Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed • Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes • Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent