Director, Pharmacometrics-Bay area, CA Description: Help apply quantitative analysis methods and PK/PD modeling techniques in developing candidate drug products through clinical development. Serve as an expert to all relevant disciplines and ensure that modeling and simulation (M&S) methods are utilized optimally in development activities. Plan and execute PK/PD M&S activities. Represent the Pharmacometrics group in project team meetings, collaborating with others on the principles and theories of quantitative evaluation of new products. In collaboration with other members of project teams, make decisions impacting PK/PD analysis goals and the success and relevance of individual studies. Contribute to the design and preparation of pharmacokinetics development strategies and study protocols, performing and supervising pharmacokinetic and pharmacodynamic analyses, and preparation of clinical study reports and integrated summary documents. Provide feedback and direction for regulatory submission preparations and review support for new or existing products. Work closely with clinical operations, biostatistics, data management, research, drug metabolism, and therapeutics areas. Contribute to the development and implementation of guidelines and SOPs within the Pharmacometrics group. Provide scientific/technical guidance, leadership, and decision-making as appropriate. Provide regular performance feedback, development, and coaching to direct reports.
Requirements: A minimum of PhD in pharmacokinetics/pharmacodynamics, pharmacometrics, or related field is required. A minimum of 8 years of experience in designing, analyzing, and reporting drug development studies is required. Equivalent experience may be accepted.. Proficiency in the use of major PK/PD software such as WinNonlin, Monolix, or NONMEM is required, as is working knowledge of software used to create graphical output and report study results. Strong written and verbal communication skills are required; must be able to independently create high quality written reports and summary documents for use in regulatory submissions. Desire to work in a cross-functional drug development team environment with all levels of employees and management is valued. Must be goal-oriented, quality-conscientious, and project-focused, with demonstrated ability to develop successful influential relationships with colleagues, both internal and external. Please email me at [email protected]<mailto:[email protected]> for more info or call at 315-415-4353 [cid:[email protected]] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 720-328-9526 - Office 315-415-4353 - Mobile 720-475-1176 - Fax [cid:[email protected]] <http://www.linkedin.com/profile/view?id=19937880&authType=name&authToken=b5d_>
