PK/PD Principal Scientist

Role Summary

The PK/PD Principal Scientist will design, conduct, analyze, and interpret in vivo PK/PD studies across multiple species to support veterinary medicine projects from early research through late-stage development. The role requires a highly motivated, independent leader able to collaborate across teams in a hybrid on-site/remote environment at Zoetis VMRD in Kalamazoo, MI ‚â•50% of the time.

Responsibilities

• 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.

Qualifications

• 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.
• Must have excellent verbal & written communication skills.
• Self-starter, able to prioritize work and work efficiently with minimal supervision.

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.

Education

• Ph.D in pharmacology, biochemistry, or related field (as listed under Qualifications).