Director, Clinical Pharmacology

This position is Full-Time and Remote-based anywhere in the United States or Canada.Why DSSS?Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global CRO while operating within a sponsor environment and utilizing sponsor systems. These sponsor clients include world class pharmaceutical and biotech companies offering you a unique opportunity to work on a team where your role is both challenging and rewarding, while working alongside colleagues who are passionate about influencing the future of medicine and advancing therapies. With IQVIA's DSSS business unit, you are not just another cog in the machine; you become a core part of a dynamic team dedicated to reshaping the future of healthcare.Additional Benefits:Home-based remote work opportunitiesGreat work/life balanceCollaborate on projects and innovations with industry leaders in the Pharma and CRO sectorsCohesive team environment fostering a collaborative approach to study workVariety of therapeutic areas, indications and, study phasesJob stability; long-term engagements and development opportunitiesCareer advancement opportunitiesResponsibilities:Contribute to 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 Clinical Pharmacology staff on study design, or other aspects of Clinical Pharmacology projects, and clinical development plans.Review analyses and documents prepared by CROs to help ensure accuracy and appropriatenessPrepare or review PK/PD sections of dossiers for product registration and communicate with regulatory agencies.Ensure quality and timely delivery of the project PK/PD deliverables.Participate on project-related cross functional teams that include Project Manager, CRA, Data Manager, Biostatistician, Programmer, and/or Medical Writer.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.Education and Experience:PharmD, Ph.D., or Master’s Degree in Pharmacy or related field in Pharmacokinetics, Pharmaceutics, or similar requiredMinimum of 10 years’ experience within Pharmacokinetics, Pharmaceutics, including Clinical Research Organization or pharmaceutical environmentSound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling, current therapeutic environment and drug development trendsStrong understanding of the principles of the drug development process, ICH GCP, and applicable International and national regulatory requirementsGood problem solving and analytical skillsExcellent computer skills, including proficiency with Microsoft Office, WinNonlin, and graphing, as well as NONMEM, R, and basic SAS programmingExcellent verbal and written communication skills and highly effective interpersonal, and organizational skillsAbility to prioritize, and independently coordinate and manage PK/PD component of complex projectsAbility to interact in a cross-functional and multi-cultural team environmentAbility to establish and maintain effective working relationships with coworkers, managers and clients.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comWe are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoeIQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-statusThe potential base pay range for this role, when annualized, is $140,400.00 - $260,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.