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).
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. QualificationsSkills: 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.
- Attention To Detail
- Clinical Study Reports
- Clinical Trials