Job Description Summary Job Overview Perform analysis and reporting of Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies. Provide consulting on study design, or other aspects of Clinical Pharmacology projects, clinical development plans, and dossiers for product registration. Assist Clinical Pharmacology management in implementing strategic initiatives.
Essential Functions ● As a project PK Scientist develop or oversee the development of protocols, statistical analysis plans, PK/PD analysis, PK/PD tables, listings and figures, and clinical study reports for Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, mass balance, concept testing, bioavailability, thorough QTc, drug-drug interactions, and special population (age effects, renal disease, hepatic disease, gender effects, etc.), as well as population PK/PD studies. ● Consult with clients, external IQVIA divisions, and Clinical Pharmacology staff on study design, or other aspects of Clinical Pharmacology projects, and clinical development plans. ● Prepare PK/PD sections of global dossiers for product registration and communicate with local regulatory agencies. ● Ensure quality and timely delivery of the project PK/PD deliverables to IQVIA clients. ● Provide update to the IQVIA Project Manager on status of project PK/PD deliverables. ● Participate on project-related cross functional teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and/or Medical Writer. ● Consult and interact with clients, other IQVIA divisions, and third-party vendors. ● Provide technical training, guidance, and mentorship to lower level and new staff. ● Participate in proposal and budget development for Clinical Pharmacology PK/PD components of business proposals. ● Recommend and assist in implementation of quality control (QC) assessment and procedures and scientific review. ● Assist management in implementing strategic initiatives. ● Maintain awareness of overall developments in the field of Clinical Pharmacology and PK/PD based on current literature, application of new technology, attendance at professional meetings, etc. ● Perform other duties as assigned by Clinical Pharmacology Management.
Qualifications ● Ph.D. or educational equivalent in Pharmacokinetics, Pharmaceutics, or related field Req Or ● Master's Degree or PharmD in Pharmacy or related field Req ● 5 years experience Req Or ● 7 years experience Req Or ● Equivalent combination of education, training and experience Req ● Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling as required, current therapeutic environment and drug development trends ● Sound knowledge of appropriate PK/PD standards and processes ● Strong understanding of the principles of the drug development process, ICH GCP, and applicable International and national regulatory requirements ● Good coaching and mentoring skills ● Good problem solving and analytical skills ● Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, and SigmaPlot graphics, as well as NONMEM, SPlus and basic SAS programming, as required ● Excellent verbal and written communication skills and highly effective interpersonal, and organizational skills ● Ability to work within a matrix team environment ● Ability to prioritize, and independently coordinate and manage PK/PD component of complex projects ● Ability to interact in a cross-functional and multi-cultural team environment ● Ability to establish and maintain effective working relationships with coworkers, managers and clients
