Clinical Pharmacology Specialist

2 weeks ago


Durham, North Carolina, United States 5PY US Quintiles, Inc. Full time

Job Summary

We are seeking a highly skilled Clinical Pharmacology Specialist to join our team at 5PY US Quintiles, Inc. This is a challenging and rewarding opportunity to work on complex projects and contribute to the development of innovative medical treatments.

Key Responsibilities

  • Contribute to the development of protocols, statistical analysis plans, and clinical study reports for Phase I-IV clinical pharmacology studies.
  • Collaborate with clients and internal teams to design and implement clinical pharmacology projects.
  • Review and analyze data prepared by CROs to ensure accuracy and appropriateness.
  • Prepare and review PK/PD sections of dossiers for product registration and communicate with regulatory agencies.

Requirements

  • Master's Degree in Pharmacy or related field in Pharmacokinetics, Pharmaceutics, or similar.
  • Minimum of 10 years' experience within Pharmacokinetics, Pharmaceutics, including Clinical Research Organization or pharmaceutical environment.
  • Sound knowledge of Pharmacokinetic concepts, including noncompartmental analysis and population PK modeling.
  • Excellent computer skills, including proficiency with Microsoft Office, WinNonlin, and graphing, as well as NONMEM, R, and basic SAS programming.

About Us

5PY US Quintiles, Inc. 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.



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