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
Masters Degree or PharmD in Pharmacy or related field Req
5 years experience 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, SPlus 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

Research Director Pharmacokinetics

Job Description

Required Skills