Director, Pharmacokinetics

Location-Home-based in the U.S or Canada

Join us on our exciting journey!

IQVIA’s Clinical Pharmacology Group is hiring! This team supports the pharmacokinetics and pharmacodynamic components of all phases of clinical studies, from study design, through protocol development, analysis and reporting. Our scientists additionally serve as consultants, both internally and externally, and their early engagement helps identify gaps in the drug development strategy and in individual protocols.

Job Overview:

As a Director, Pharmacokinetics, you will provide direction to a designated group of Clinical Pharmacology PK/PD scientists to ensure projects are resourced appropriately and employees are trained to meet project needs. You will assist in formulating effective strategic goals and objectives, assure implementation and operational integration of those goals, and manage the PK/PD components of specified projects, including budget management. You may also serve as a consultant or project PK scientist for complex Clinical Pharmacology projects, as required.

Responsibilities:

• 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.

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.

What is in it for you?

• Ability to help shape the future of the Clinical Pharmacology department
• Interesting and innovative projects
• Collaborative and inspirational working environment

#LI-Remote

#LI-NITINMAHAJAN

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.com

IQVIA is proud to be an equal opportunity employer. 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. https://jobs.iqvia.com/eoe

The 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.