REQUIREMENTS:

• Experience :
• Typically requires a minimum of 7-10 years of relevant experience, including Clinical Pharmacology and line management.
• Education :
• Ph.D. in Pharmacokinetics, Pharmaceutics, or related field (preferred).
• Master’s Degree or PharmD in Pharmacy or related field (acceptable).
• Skills and Abilities :
• Sound knowledge of pharmacokinetic concepts, drug development process, and regulatory requirements.
• Advanced knowledge of noncompartmental analysis and software (WinNonLin preferred)
• Experience with population PK modeling and relevant software (R and NONMEM preferred)
• Experience with regulatory submissions.
• Excellent problem-solving, analytical, computer, communication, and leadership skills.
• Ability to work within a matrix team environment and interact in a cross-functional and multi-cultural environment.

• Study Design and Development : Design studies, develop clinical development plans, protocols, statistical analysis plans, PK/PD analysis, tables, listings, figures, and clinical study reports for Phase I-IV clinical pharmacology and population PK studies.
• Resource Management : Allocate PK/PD resources, manage project assignments, and capacity.
• Quality Control : Implement QC assessment and procedures, scientific review, and ensure timely delivery of PK/PD deliverables.
• Technical Training and Mentoring : Provide training and mentoring to PK/PD scientists and staff.
• Regulatory Communication : Prepare PK/PD sections of global dossiers for product registration and communicate with regulatory agencies worldwide.
• Cross-Functional Integration : Serve as a liaison to other IQVIA departments and promote integration and harmonization.
• Business Development : Participate in proposal and budget development, marketing services, and developing new client and project opportunities.
• Management : Manage staff in accordance with organization’s policies and applicable regulations, including planning, assigning, and directing work; appraising performance; guiding professional development; rewarding and disciplining employees; addressing employee relations issues; and resolving problems.