Sr. Research Associate

Location
Bothell, WA, United States
Posted
Feb 13, 2019
Ref
oY8d9fwc
Discipline
Science/R&D, Research
Required Education
Bachelors Degree
Position Type
Full time
Summary:

The Translational Sciences department is searching for a highly motivated and experienced DMPK associate scientist for management of CRO and internal activities to support discovery and development of antibody-drug conjugate and small molecule drugs. The ideal candidate will have extensive DMPK development experience in the following areas: GLPs, GCPs, and regulatory agency guidelines, technical or medical writing, non-clinical and clinical DMPK studies to support regulatory submission of NCEs and NBEs, in vitro enzyme and transporter assays, LC/MS bioanalysis, and PK.

Responsibilities:
  • Perform or assist in PK/TK data analysis and modeling, write PK/TK reports, and conduct data QC and formatting
  • Assist in QC and analysis of in vitro and in vivo ADME and bioanalytical data for small molecules, antibodies, and antibody-drug conjugates
  • Construct/maintain a tracking system to monitor DMPK study progress effectively across discovery and development portfolio
  • Serve as a technical expert on drug metabolism assays, responsible for internal DMPK assay protocol/report template preparation and development, assist in assay data analysis and report writing
  • Effectively manage numerous projects simultaneously to meet deadlines while maintaining organizational integration within DMPK
  • Review or assist in reviewing DMPK components of preclinical and clinical regulatory filing documentations and study reports, and writing study summaries for presentation
  • Manage CROs, oversee/coordinate outsourced DMPK study logistics and activities, QC data, review study protocols and reports
  • Effectively communicate study progress, timelines, needs and results back to DMPK team and other key stakeholders in a timely manner to ensure alignment and influence decisions


Qualifications:
  • B.S. with a minimum of 10 years of industry experience in DMPK
  • Extensive writing and laboratory experience in development DMPK studies including ADME, in vitro and cell-based assays, metabolite profiling/identification, bioanalysis, and PK
  • Direct CRO experience in DMPK or drug metabolism CRO management experience is preferred
  • Track record of managing big numbers of complex projects simultaneously and efficiently
  • Experience with appropriate use of radioactivity for in vivo and in vitro ADME studies and extensive cell culture experience are considered beneficial
  • Good understanding of drug development, familiar with GLPs, GCPs, and regulatory agency guidelines, clinical research and study design
  • Proven ability on efficient technical/medical writing in DMPK is essential
  • Strong team player, solution-oriented, strong analytical, organizational and time-management skills


As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.