Research Pharmacokinetics Director (Remote)

*Role is Home Based/Remote anywhere in the US or Canada.

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 5 years experience Or Equivalent combination of education, training and experience Req

• Master's Degree or PharmD in Pharmacy or related field 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, R 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

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.