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All- Amgen's Seattle Washington site currently has an opening for a Principal Scientist. Job Posting Title Principal Scientist - Pharmacokinecits/Pharmacometrics - NB50223498 - Seattle, WA Country USA Branch Washingtion City Seattle Pay Level 06 Basic Qualifications Basic Qualifications: Ph.D. in Pharmacokinetics (PK), engineering, pharmacology, or biostatistics or a Life Sciences field with a minimum of 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 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. A strong understanding of theoretical aspects of PK/PD with respect to M&S and demonstrated application is required. Preferred Qualifications: Candidate with good R&D experience in oncology therapeutics or inflammation area and previous work experience in pharmacometric (modeling & simulation) department is preferred. Demonstrated experience with M&S software (e.g. NONMEM, Adapt II, Pharsight Trial Simulator, SAS,) Job Summary Job Description: In the role of Principal 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). 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. The successful candidate will be responsible for implementing advanced modeling & simulation (M&S) techniques in drug development support, developing cutting edge M&S methodology, working collaboratively with other staff in cross functional team environment to ensure the design, analysis, and interpretation of pharmacokinetic/ pharmacodynamic (PK/PD) studies are optimized to investigate the ranges and sources of variability. Key responsibilities will include participating on cross-functional project teams, providing functional input, and leading the PK/PD analyses and interpretations for assigned projects. The incumbent will be responsible for completing and reporting analyses and results within preclinical and clinical studies using advanced PK/PD and M&S techniques, develop PK/PD program plan and conduct simulation analysis to support clinical trial design at various phases of drug development. The candidate will contribute to the preparation and maintenance of Investigator Brochures, IND/CTAs, and other summary documents for regulatory submissions. Please contact Alex Yoo or Megan Gibbs if you are interested. Alex Yoo Staffing Consultant AMGEN 805-447-1233 Megan Gibbs, Ph.D., Director Pharmacokinetics and Pharmacometrics Pharmacokinetics and Drug Metabolism Amgen Inc. 1201 Amgen Ct. West AW2/D2262 Seattle, WA 98119-3105 206-265-8865 (office) [email protected]<mailto:[email protected]>