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]>