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Pharmacokinetics Opportunities at Parexel

By being hired into one of our Pharmacokinetics jobs at Parexel International, you’ll be a key member of the Parexel International team. Professionals in Pharmacokinetics careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A job in Pharmacokinetics at Parexel International may be waiting for you!

Associate Director, Clinical Pharmacology, Modelling & Simulation

Job ID 60838BR United Kingdom - Any Region - Home Based
Parexel has a new home based opportunity for an Associate Director, Clinical Pharmacology, Modelling & Simulation. The Associate Director ensures the strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development. Individuals will provide support for PK/PD strategy and interpretation to other SBUs and clients. The Associate Director will provide quality services to clients. The candidate selected for this position will ideally have experience in physiologically-based pharmacokinetic (PBPK) modelling experience ideally in the GastroPlus software (or other similar software e.g. PK Sim or SimCYP).

Key Accountabilities:

  • To analyze clinical PK/PD data as a member of several multidisciplinary development program teams.
  • To work with clinical teams to design PK/PD components in various study designs such as first-in-human, bioequivalence and drug-drug interaction studies.
  • Responsible for authoring or contributing to clinical PK/PD sections of relevant documents.
  • Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of development.
  • Review of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports.
  • Provides Quality Control (QC) for WinNonlin and NONMEM analysis.
  • Review of derived PK/PD data generated by PK Analyst.
  • Maintaining a strong working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.
  • Developing and maintaining a relationship with internal and external clients and scientists.
  • Provides leadership and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
  • Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
  • To provide scientific support and advice to relevant Parexel staff.
  • Provide training and guidance and act as a mentor to less experienced departmental members.
  • Reviewing/Authoring scientific publications, abstracts, posters.

Qualifications

Skills:
  • Excellent knowledge of PK and PD principles.
  • Strong experience with the design and implementation of Model-Based Drug Development strategies.
  • Knowledge of Pharmacometric methodologies (e.g., conc-QT analysis, clinical trial simulation)
  • Experience in Pharsight Software (PKS/WinNonlin/Phoenix)
  • Experience in other software such as NONMEM, GastroPlus and R is desirable.
  • Experience in clinical drug development of both NCEs and biologicals.
  • Excellent interpersonal, verbal and written communication skills.
  • Strong clinical/scientific writing skills.
  • Client focused approach to work ethic.
  • Exhibits and promotes a flexible attitude with respect to work assignments and new learning.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
  • Willingness to work in a matrix environment and to value and promote the importance of teamwork.
  • Demonstrated understanding of the drug development process and a knowledge of FDA and EMEA guidelines.

Knowledge and Experience:
  • Typically 6-10 years’ experience in drug development.

Education:
  • Advanced science degree (PhD, PharmD) and/or relevant experience.

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