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Amgen is a leading human therapeutics company in the biotechnology industry.
For more than 25 years, the company has tapped the power of scientific
discovery and innovation to advance the practice of medicine.
Amgen pioneered the development of novel products based on advances in
recombinant DNA and molecular biology and launched the biotechnology industry's
first blockbuster medicines. Today, as a Fortune 500 company serving millions
of patients, Amgen continues to be an entrepreneurial, science-driven
enterprise 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
Global Development Teams, providing functional area expertise in the
development programs and non-clinical/clinical study design involving PK and
PK/PD. Effectively interface within the PKDM department and with external
functions (such as Toxicology, Early Development, Clinical Development,
Biostatistics, Regulatory affairs, and CMC). Perform Modeling and Simulation to
support clinical development. Identify and resolve PK/PD issues, assist /lead
preparation of regulatory document sections, and represent the company as
technical 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
experience in the Biotechnology/Pharmaceutical Industry. Knowledge of PK and
PK/PD for small molecule and/or protein therapeutics. Experience as PK/PD lead
on development project teams, clinical protocol development, and PK/PD data
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
management and resolution of complex, project-related issues involving multiple
functional areas and levels of management.
For immediate consideration, please send your resume to Alex Yoo at
[email protected]<mailto:[email protected]> or visit on our career website at
http://www.amgen.com/careers/job_search_us.html and click on the hyperlink
"Click here to Search for Jobs." On the "Search For" box, please enter
NB50892474