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Pharmacometrics position at Nektar Therapeutics

From: Gordi, Toufigh <TGordi>
Date: Thu, 22 Mar 2018 01:53:02 +0000

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 expan=
ding Pharmacometrics group and the new AD will work closely with other mode=
lers and non-modelers to advance drug candidates from preclinical to late c=
linical phases by applying state of the art quantitative analysis technique=
s..

Nektar Therapeutics continues to advance a model-based drug development par=
adigm 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 off=
er a highly collaborative and scientific environment and the opportunity to=
 shape the future of the company's path toward a more effective and model-b=
ased drug development process.

Responsibilities:
Help apply quantitative analysis methods and PK/PD modeling techniques in d=
eveloping candidate drug products from preclinical through Phase 3 studies.=
 Serve as an expert to all relevant disciplines and ensure that modeling an=
d simulation (M&S) methods are utilized optimally in discovery and developm=
ent activities. Plan and execute PK/PD M&S activities in the design and an=
alysis of in vivo and in vitro studies working with a multidisciplinary tea=
m. Represent the Pharmacometrics group in project team meetings, collabora=
ting with others on the principles and theories of quantitative evaluation =
of new products. In collaboration with other members of project teams, mak=
e 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 strat=
egies and study protocols, performing and supervising pharmacokinetic and p=
harmacodynamic analyses, and preparation of clinical study reports and inte=
grated summary documents. Provide feedback and direction for regulatory su=
bmission preparations and review support for new or existing products. Wor=
k closely with clinical operations, biostatistics, data management, researc=
h, 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 coachi=
ng 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 y=
ears of experience in designing, analyzing, and reporting nonclinical and c=
linical drug development studies is required. Equivalent experience may be =
accepted. Must be proficient in creation and management of datasets with wo=
rking knowledge in the use of R or SAS in creating data files for pharmacom=
etrics analysis. Proficiency in the use of major PK/PD software such as Win=
Nonlin, Monolix, or NONMEM is required, as is working knowledge of software=
 used to create graphical output and report study results. Strong written a=
nd verbal communication skills are required; must be able to independently =
create high quality written reports and summary documents for use in regula=
tory submissions. Desire to work in a cross-functional drug development tea=
m environment with all levels of employees and management is valued. Must b=
e goal-oriented, quality-conscientious, and project-focused, with demonstra=
ted ability to develop successful influential relationships with colleagues=
, both internal and external. Must be self-driven and be able to work indep=
endently or with little supervision to set expectations and negotiate prope=
r milestones to track progress.


Toufigh Gordi, PhD, MBA
Senior Director of Pharmacometrics
Nektar Therapeutics
Tel.: 415-482-5306
Email: tgordi



Received on Wed Mar 21 2018 - 21:53:02 EDT

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