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 & SimulationJob ID 60838BR United Kingdom - Any Region - Home Based
- 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.
- 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.
- Advanced science degree (PhD, PharmD) and/or relevant experience.
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