IQVIA Research Pharmacokinetics Director in Overland Park, Kansas
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.
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.
Typically requires 7 - 10 years of prior relevant experience.
Requires extensive knowledge of multiple job areas obtained through advanced education and experience.
Ph.D. or educational equivalent in Pharmacokinetics, Pharmaceutics, or related field 5 years experience
Master's Degree or PharmD in Pharmacy or related field 7 years experience
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