A 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
