Associate Director, CPMS

Key AccountabilitiesAnalyze clinical PK/PD data as a member of several multidisciplinary development program teamsWork with clinical teams to design PK/PD components in various study designs such as first-in-human, Proof of Concept, Phase 2B, bioequivalence and drug-drug interaction studies.Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of developmentReview/author scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports, regulatory responses and submissions and publications for peer review journalsMaintain a strong working knowledge of pharmacology, biology, therapeutics, drug metabolism, b ioanalysis, and b iopharmaceuticsDevelop and maintain a relationship with internal and external clients and scientistsResponsible for the strategic and operational delivery of client programs and projects to timelines, quality expectations and regulatory requirements.Drive embedding of LEAN concepts in process deployment and improvementProvide subject matter expertise to internal Parexel teams as neededInitiate and contribute to department and cross-BU improvement and training initiatives.Identify, quantify and as appropriate mitigate risks within the team driving business continuity and quality.QualificationsStrong knowledge of PK and PD principlesStrong experience with the design and implementation of Model-Based Drug Development strategiesExpertise with Pharmacometric methodologies (e.g., disease modelling, conc-QT analysis, clinical trial simulation)Experience in Pharsight Software (PKS/WinNonlin/Phoenix)Experience in other software such as NONMEM, GastroPlus and R is desirableSignificant experience in clinical drug development of both NCEs and biologicalsExcellent interpersonal, verbal and written communication skillsExtensive clinical/scientific writing skillsClient focused approach to work ethicExhibits and promotes a flexible attitude with respect to work assignments and new learningAbility to direct and manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailWillingness to work in a matrix environment and to value and promote the importance of teamwork.Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations