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]