NONMEM Users Network Archive

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From: Gibbs, Megan <gibbsm>
Date: Thu, 24 Sep 2009 15:25:00 -0700


Amgen is a leading human therapeutics company in the biotechnology industry=
. For more than 25 years, the company has tapped the power of scientific di=
scovery and innovation to advance the practice of medicine.
Amgen pioneered the development of novel products based on advances in reco=
mbinant DNA and molecular biology and launched the biotechnology industry's=
 first blockbuster medicines. Today, as a Fortune 500 company serving milli=
ons of patients, Amgen continues to be an entrepreneurial, science-driven e=
nterprise dedicated to helping people fight serious illness.

Sr Scientist - Pharmacokinetics - Seattle, WA (NB50892474)

Job Description:
In the role of Senior Scientist, will serve as the PKDM representative on G=
lobal Development Teams, providing functional area expertise in the develop=
ment programs and non-clinical/clinical study design involving PK and PK/PD=
. Effectively interface within the PKDM department and with external functi=
ons (such as Toxicology, Early Development, Clinical Development, Biostatis=
tics, Regulatory affairs, and CMC). Perform Modeling and Simulation to supp=
ort clinical development. Identify and resolve PK/PD issues, assist /lead =
preparation of regulatory document sections, and represent the company as t=
echnical expert in interactions with regulatory authorities. Management and=
 development of PK associate(s) may also be key responsibilities.

Basic Qualifications:
Ph.D. in Pharmacokinetics
3+ years experience in the Biotechnology/Pharmaceutical Industry

Preferred Qualifications:
Ph.D. in Pharmacokinetics (PK) or a Life Sciences field with 3-7 years expe=
rience in the Biotechnology/Pharmaceutical Industry. Knowledge of PK and PK=
/PD for small molecule and/or protein therapeutics. Experience as PK/PD lea=
d on development project teams, clinical protocol development, and PK/PD da=
ta analysis and interpretation. Experience in PK/PD modeling and population=
 analyses/simulations preferred (NONMEM, S-PLUS,Pharsight Trial Simulator).
Experience in authoring regulatory documentation (IND, IMPD, CTX, CTD, MAA,=
 etc), and interaction with regulatory authorities. Excellent interpersonal=
, scientific, technical, and communication skills that enable effective man=
agement and resolution of complex, project-related issues involving multipl=
e functional areas and levels of management.

For immediate consideration, please send your resume to Alex Yoo at ayoo<mailto:ayoo and click on the hyperlink "Click her=
e to Search for Jobs." On the "Search For" box, please enter NB50892474

Received on Thu Sep 24 2009 - 18:25:00 EDT

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