PK/PD Principal Scientist at Zoetis

Kalamazoo, Michigan, United States

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Veterinary Medicine, PharmaceuticalsIndustries

Ph.D in pharmacology, biochemistry, or related field with 4 or more years of relevant pharmaceutical development experience
Proven ability to design, analyze and interpret in vivo PK and PK/PD studies
Experience with biotherapeutics (protein therapeutics) is highly desirable
Skilled in the use of PK and PK/PD analysis software such as WinNonlin, Monolix or Watson
Excellent verbal & written communication skills
Self-starter, able to prioritize work and work efficiently with minimal supervision
Desired Skills
Working knowledge of bioanalytical methodology
Knowledge of ADA assays and assessment of immunogenicity of biotherapeutics
Experience in PK/PD modeling and simulation such as PBPK, QSP or population PK modeling using NONMEM, R, or related software
Experience interacting with regulatory agencies
Experience conducting GLP studies

Independently design, conduct and analyze in vivo PK/PD, PK and TK studies in multiple veterinary species, including writing study protocols and reports
Provide PK and PK/PD modeling and simulation to help select lead candidates and optimize dose regimens
Collaborate with bioanalytical team to understand suitability of analytical assays and forecast analytical requirements for projects
Lead development of scientific strategy across therapeutic areas with a focus on mechanistic platforms/biomarkers to aid in translation, measurement of target engagement, and dose regimen predictions
Work collaboratively and communicate effectively with multidisciplinary teams to design and prosecute studies in line with the strategic direction of the project
Present research results to scientific teams, management, and regulatory agencies
Write sections of regulatory submissions, respond to inquiries from regulatory agencies, and maintain knowledge of regulatory guidance documents