Senior Scientist, Clinical Pharmacology

Bachelor’s degree and 10 years of experience or master’s degree and 8 years of experience in life sciences, pharmaceutical sciences, pharmacology 8 years of experience in conducting clinical pharmacology studies including study design, PKPD data analysis, and interpretation of results PhD in Pharmaceutical Science, Math or related discipline preferred Strong quantitative experience (e.g., pharmacometrics, pharmacokinetics/pharmacodynamics, quantitative systems pharmacology, statistics) Working knowledge of PKPD modelling approaches (including population PKPD approaches), bioanalysis, data analysis and biostatistics, programming Broad familiarity with the drug development process Extensive hands-on Phoenix WinNonlin experience, R, SAS, NONMEM, or other PKPD data analysis or modeling platforms preferred Strong attention to detail with extensive experience reviewing and interpreting complex PK and PD data Strong interpersonal skills, with the ability to work across cross-functional teams Project management skills with sense of urgency, ability to collaborate and influence across teams Demonstrated ability to work across functions including medical writing, clinical operations, biometrics, clinical development, quality and regulatory affairs Excellent communication skills, both verbal and written

Responsible for pharmacokinetic modeling Analyzing clinical PK data using non-compartmental analysis Engaging in translational research efforts Exploring exposure/response relationships Developing and executing translational plans beyond pharmacokinetics Design and implement appropriate clinical modeling Author clinical pharmacology aspects of clinical study protocols, analysis plans, reports, and related regulatory and clinical documents Perform non-compartmental analyses (NCA) of clinical PK data Influence the development of drugs and expand the application of model-informed drug development (MIDD) approaches Engage with and manage outside vendors, partners and consultants Support internal modeling and analysis outside of Clinical Pharmacology Contribute to the development or improvement of tools, processes and methodology Manage translational research efforts associated with clinical trial objectives Partner with key stakeholders and colleagues Influence and lead the external environment through scientific societies, publications, presentations, and collaborations