Job Overview

Perform analysis and reporting of simple Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, bioavailability, and drug-drug interactions, as well as population PK studies as required. Collaborate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.

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 simple Phase I-IV clinical pharmacology studies, such as dose tolerance, dose proportionality, bioavailability, and drug-drug interactions, as well as population PK studies.

• Ensure quality and timely delivery of the project PK/PD deliverables to clients.

• Provide progress updates/reports on the PK/PD deliverables the Project Manager.

• Participate on project-related cross functions teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and Medical Writer.

• Manage customer relationships and interact with internal business units, and third-party vendors at project level.

• Provide training and guidance to lower level and new staff as required.

Qualifications

• Ph.D. in Pharmacokinetics, Pharmaceutics, or related field Req Or

• Master's Degree or PharmD in Pharmacy or related field Req Or

• Bachelor's Degree in Pharmacy or related field Req

• 1 year experience Req Or

• 2 years relevant experience Req Or

• 5 years relevant experience Req Or

• Or equivalent combination of education, training and experience Req

• Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling as required

• Sound knowledge of appropriate PK/PD standards and processes

• Basic understanding of the principles of the drug development process, ICH GCP, and applicable International and National regulatory requirements

• Good computer skills, including proficiency with Microsoft Office, WinNonlin, and SigmaPlot graphics, as well as NONMEM, SPlus and basic SAS programming, as required

• Good verbal and written communication skills and good interpersonal skills

• Ability to problem solve

• Ability to work within a matrix team environment

• Ability to effectively manage multiple tasks and 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

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.