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Principal Scientist, PK/PD
ZoetisPK/PD Principal Scientist responsible for designing and analyzing studies in veterinary medicine. Collaborating with multidisciplinary teams to advance therapeutics from research to development phases.
About the role
Key responsibilities & impact- Independently design 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 assess 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.
Requirements
What you’ll need- Ph.D in pharmacology, biochemistry, or related field with 4 or more years of relevant pharmaceutical development experience
- DVM DACVCP or DVM Dipl. ECVPT is highly desirable
- 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
- Working knowledge of bioanalytical methodology
- Knowledge of ADA assays and assessment of immunogenicity of biotherapeutics is highly desirable
- Experience in PK/PD modeling and simulation such as PBPK, QSP or population PK modeling using NONMEM, R, or related software is highly desirable
- Experience interacting with regulatory agencies is highly desirable
- Experience conducting GLP studies is desirable.
- Must have excellent verbal & written communication skills.
- Self-starter, able to prioritize work and work efficiently with minimal supervision.
Benefits
Comp & perks- Healthcare and insurance benefits beginning on day one
- 401K plan with a match and profit-sharing contribution from Zoetis
- 4 weeks of vacation
- Short-term incentive compensation
- Long-term incentives
ATS Keywords
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Hard Skills & Tools
in vivo PK studiesin vivo PD studiesPK/PD modelingdose regimen optimizationbiotherapeuticsbioanalytical methodologyADA assaysimmunogenicity assessmentPBPK modelingpopulation PK modeling
Soft Skills
collaborationcommunicationscientific strategy developmentpresentation skillsself-starterprioritizationindependenceteamworkproblem-solvingadaptability
Certifications
Ph.D in pharmacologyPh.D in biochemistryDVM DACVCPDVM Dipl. ECVPT