Job Description

Responsibilities

• Contribute to drug development decisions in different therapeutic areas and with different customers. Prepare PK/PD sections of global dossiers for product registration and communicate with regulatory agencies worldwide.

• Develop or oversee the development of protocols, statistical analysis plans, PK/PD analysis, PK/PD outputs, and clinical study reports for clinical pharmacology studies (e.g. dose tolerance, dose proportionality, bioavailability, bioequivalence, food effect and drug-drug interactions)
• Develop dose- and exposure-response analyses, dose optimization analyses as well as analyses for population PK studies.
• Ensure quality and timely delivery of the project PK/PD deliverables to customers.
• Provide progress updates/reports on the PK/PD deliverables to the Project Manager.
• Participate on project-related cross functions teams that include Project Manager, CRA, Data Manager, Biostatistician, Statistical 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.
• Participate in proposals and budgets development for Clinical Pharmacology PK/PD components.
• Responsible for the planning and delivery of the Clinical Pharmacology PK/PD components of specified project(s) in accordance with the scope of work and contracted timelines.
• Recommend and assist in implementation of quality control (QC) assessment and procedures and scientific review.
• Maintain awareness of overall developments in the field of Clinical Pharmacology and PK/PD based on current literature, application of new technology, etc.
• Assist management in implementing strategic initiatives.

Skills and Abilities

• Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling and simulations as required, current therapeutic environment and drug development trends
• Sound knowledge of Pharmacokinetic, pharmacometrics, clinical pharmacology concepts, and population PK/PD modeling with strong quantitative skills applied to develop models and simulations to respond to specific drug-development questions.
• Proficiency in software used for modeling analyses and dataset construction/manipulation (e.g. WinNonlin, NONMEM, Pirana Modeling Workbench, Monolix, Adapt, SigmaPlot graphics, SPlus and SAS and/or R).
• Good coaching and mentoring skills
• Good problem solving and analytical skills
• 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
• Ability to effectively manage multiple tasks and projects within the assigned budget.

Qualifications:

• MSc, PhD, PharmD, or equivalent in Pharmaceutical Sciences, Pharmacology, Pharmacokinetics, Pharmacometrics, Statistics, Mathematics, or related fields.
• A minimum of 10 to 13 years of industry/CRO experience (it can also be combined with academic research) working in R&D, pre-clinical and clinical environments.
• Solid understanding of the principles of the drug development process, ICH GCP, and applicable International and National regulatory requirements.
• Proficient in spoken and written English.
• Significant line management experience desirable.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible \xe2\x80\x93 to help our customers create a healthier world. Learn more at
https://jobs.iqvia.com