New position at Nektar Therapeutics: Associate Director of Pharmacometrics

Position Summary: Nektar Therapeutics is seeking an experienced pharmacometrician to join the company at the Associate Director (AD) level. The position is in the pharmacometric group, a part of the clinical pharmacology department, and the new AD will work closely with other modelers and non-modelers to advance drug candidates from preclinical to late clinical phases by applying a model-based drug development paradigm. Nektar Therapeutics continues to advance a model-based drug development paradigm throughout the organization. The current position offers an exciting opportunity to be a contributing part of the company's efforts in promoting quantitative analysis techniques at all stages of drug development. We offer a highly collaborative and scientific environment and the opportunity to shape the future of the company's path toward a more effective and model-based drug development process. Responsibilities: Help apply quantitative analysis methods and PK/PD modeling techniques in developing candidate drug products from preclinical through Phase III. Serve as an expert to all relevant disciplines and ensure that modeling and simulation (M&S) methods are used optimally in discovery and development activities. Plan and execute PK/PD M&S activities in the design and analysis of in vivo and in vitro studies working with a multidisciplinary team. Represent clinical pharmacology/quantitative analysis in project team meetings, collaborating with others on the principles and theories of quantitative evaluation of new products. In collaboration with other members of the team make decisions impacting PK/PD analysis goals and the success and relevance of individual preclinical and clinical studies. Contribute to the design and preparation of preclinical and clinical 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 submissions preparation and review support for new or existing products. Work closely with clinical operations, biostatistics, data management, research, drug metabolism, and therapeutics areas. Help oversee and maintain Nektar's storage of pharmacometric files and archive system. Contribute to the development and implementation of 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, if any. Requirements: A minimum of PhD in pharmacokinetics/pharmacodynamics or pharmacometrics is required. Other relevant backgrounds may be considered. A minimum of 8 years of experience in designing, analyzing, and reporting nonclinical and clinical drug development studies is required. Equivalent experience may be accepted. Must be proficient in creation and management of datasets and in use of major PK/PD software such as WinNonlin, Monolix, and NONMEM and have 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. Understand how to set expectations and negotiate proper milestones to track progress. Those interested in the position can contact me directly. Toufigh Toufigh Gordi, PhD, MBA Senior Director of Pharmacometrics Nektar Therapeutics Tel.: 415-482-5306 Email: [email protected]