Principal/Sr. Pharmacokineticist - Remote/Kansas City
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. What will you be doing? This position can be done remotely worldwide, or Kansas City based in the office. Conducts PK/PD analyses, interprets and reports results, and contributes to all phases of a clinical study involving PK/PD characterization On the study level, assists in study start-up activities and evaluates data related to the PK/PD characterization of a drug * Participates as a key team member on PK/PD studies * Provides specific input into PK/PD CRF design to ensure complete collection of data required for proper PK/PD analysis * Assists or writes PK/PD sections of Statistical Analysis Plans * Performs PK/PD data analysis and assists in interpreting the statistical results * Assists in writing PK/PD sections of Clinical Study Reports * Designs PK/PD studies; assists in writing clinical study protocols * Works with investigators and their staff to ensure proper PK/PD data collection On the program level, provides scientific expertise and oversight to drug development and/or clinical trial project teams through all program stages * Provides expertise regarding bioanalytical data interpretation for the client and internally * Provide expertise in PK, PK/PD, and exposure-response (ER) modeling and simulations * Writes or assists with writing of PK/PD sections of regulatory submission documents or manuscripts * Performs scientific literature searches and other research to support strategic overview planning and writing of proposals in support of individual clinical trials, full development programs, or standalone modeling and simulation projects * Collaborates with clients on the design of model-informed drug development programs * Works directly with the project team to provide expertise on the importance of critical PK/PD data in the analytical process and their intended use in a report or submission * Assists with the writing of clinical development plans and business plans * Participates in the RFP process * Provides feedback regarding PK/PD bids; may participate in RFP bid defense Qualifications * CRO experience is preferred, will also consider pharma experience * PharmD or Ph.D. in Pharmaceutical Sciences is ideal, but open to Master's Degree with relevant experience of 10 years * Experience performing pharmacometrics, modeling & simulation and/or biometrics required * Proficiency with Phoenix WinNonlin 8.n and NONMEM 7.n required; * Read, write and speak English; fluent in host country language required Benefits of Working in ICON: Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know. Please apply @ https://uscareers-prahs.icims.com/jobs/79663/principal-sr-population-pharmacokineticist---remote-kansas-city/job?mode=view&mobile=false&width=792&height=500&bga=true&needsRedirect=false&jan1offset=-420&jun1offset=-360<https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fuscareers-prahs.icims.com%2Fjobs%2F79663%2Fprincipal-sr-population-pharmacokineticist---remote-kansas-city%2Fjob%3Fmode%3Dview%26mobile%3Dfalse%26width%3D792%26height%3D500%26bga%3Dtrue%26needsRedirect%3Dfalse%26jan1offset%3D-420%26jun1offset%3D-360&data=04%7C01%7Cwalljaspershamus%40prahs.com%7C25349dc251624c37cea708d981d739ba%7C1cef9a5962ec418a96662b3afc2d2cb0%7C0%7C0%7C637683583662561406%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=bZdaaciE6PkuI%2Bc7AGwGpA57oy3LS44q6OB97sjP1cM%3D&reserved=0>
