Associate Director, Pharmacometrics Position Summary: Nektar Therapeutics is seeking an experienced PK/PD expert 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.
Responsibilities: Help apply quantitative analysis methods and PK/PD modeling techniques in developing candidate drug products from pre-IND through Phase III. Plan and execute the PK/PD modeling and simulation (M&S) activities in the design and analysis of in vivo and in vitro studies working with a multidisciplinary team. Conduct and collaborate with others on the principles and theories of quantitative evaluation of new products and maintenance of existing pharmacokinetics and drug metabolism product lines through the application of state-of-the-art knowledge in PK/PD analysis. In collaboration with other team members make decisions impacting PK/PD 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. Take over and maintain Nektar's storage of pharmacometric files and archive system. What we offer: Nektar Therapeutics is in the early stages of implementing a model-based drug development paradigm (MBDD) throughout the organization. The current position offers an exciting opportunity to be a contributing part of the company's efforts in such implementation. 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 science-based drug development process. Requirements: The right person for this position has a PhD in pharmaceutical sciences and PK/PD analysis and 10-13 years of industry experience. A minimum of 8-10 years previous management experience is required. Expert knowledge of scientific principles of pharmacometrics and relevant software are essential. Independent analysis and problem solving and the ability to implement the solutions using available tools are critical. The pharmacometric group is well integrated in the clinical pharmacology department and the AD is expected to contribute to a highly collaborative team. Scientific curiosity, outgoing personality, and willingness to help other team members with complex problems by offering science-based solutions, while learning new insights are highly desirable. Toufigh Gordi, PhD, MBA Senior Director of Pharmacometrics Nektar Therapeutics Tel.: 415-482-5306 Email: tgo...@nektar.com
