Associate Director, Pharmacometrics
Position Summary:
Nektar Therapeutics is seeking an experienced pharmacometrician to join the
company at the Associate Director (AD) level. The position is in our expanding
Pharmacometrics group 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 state of the art quantitative analysis techniques..
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 3 studies.
Serve as an expert to all relevant disciplines and ensure that modeling and
simulation (M&S) methods are utilized 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 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
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 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, if any.
Requirements:
A minimum of PhD in pharmacokinetics/pharmacodynamics or pharmacometrics is
required. Other relevant backgrounds may be considered. A minimum of 6-8 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 with working
knowledge in the use of R or SAS in creating data files for pharmacometrics
analysis. 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. Must be self-driven and be able to work independently or
with little supervision to set expectations and negotiate proper milestones to
track progress.
Toufigh Gordi, PhD, MBA
Senior Director of Pharmacometrics
Nektar Therapeutics
Tel.: 415-482-5306
Email: [email protected]