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Job Field: Office Jobs
Location: SEATTLE, WA
Salary: $-
Job Type: Part Time

JOB SUMMARY:

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               <td align="left"><font style="font-size: 100%;">Auto req 17294BR<BR>Job Posting Title Principal Scientist - Quantitative Pharmacology/PKDM<BR>Career Category Scientific<BR>Employee Subgroup Salaried FT<BR>Country (State/Region) United States - Washington<BR>Location (City) Seattle<BR>Amgen Job Description Amgen, Inc. is seeking a highly motivated and team-oriented candidate for the position of Principal Scientist in the Quantitative Pharmacology Group of PKDM Department. The Principal Scientist will be PKDM Development Team Representative on the Early and/or Global Development Teams in support of small and large molecule drug development, registration, and/or post-marketing activities. He/she will be responsible for program-level strategic and resource planning, communication, scientific/technical deliverables, issue resolution, and functional representation for Amgen internal governance reviews, face-to-face interactions with global regulatory/health authorities, and external scientific communities. The individual will lead PKDM Development Project Team, and interface with internal business stakeholders (such as Research, Toxicology, Early Development, Clinical Development, Biostatistics, CMC, Regulatory Affairs, etc.). The successful candidate will implement advanced modeling & simulation (M&S) strategy, develop M&S cutting edge methodology, and work collaboratively with cross-functional teams to optimize PK/PD study design and study protocol. He/she will be responsible for PK/PD analyses, modeling & simulations, report writing, and the preparation and maintenance of Investigator Brochures, IND/IMPD/CTX/RTQ/CTD, and other summary documents for regulatory submissions. Development of junior team members and interaction with the line-management will also be key responsibilities.<BR>Basic Qualifications ? Doctorate degree & 5 years of scientific experience<BR>OR<BR>? Master?s degree & 12 years of scientific experience<BR>OR<BR>? Bachelor?s degree & 15 years of scientific experience<BR>Preferred Qualifications ? PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 5+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training<BR>? Experience as PKDM/Clinical Pharmacology functional representative on product development teams<BR>? PK and PK/PD data analysis, interpretation, and reporting for small molecule and/or protein therapeutics<BR>? Hands-on experiences in population PK/PD modeling and simulations (M&S)<BR>? Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities<BR>? Leadership quality for effective team building with strong decision making and problem solving skills<BR>? Excellent interpersonal, technical, and communication skills to lead cross-functional teams<BR>? Project management skills for timeline tracking and resource planning<BR>? R&D experience in oncology therapeutics                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    </font></td>
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