PK/PD Principal Scientist

ZoetisKalamazoo, MI
1dHybrid

About The Position

The Zoetis Veterinary Medicine Research & Development (VMRD) is seeking a talented PK/PD scientist to join our team to discover and develop novel therapeutics for veterinary medicine. The successful candidate will be primarily responsible for designing, conducting, analyzing, and interpreting in vivo PK/PD studies in multiple species in support of projects from early research through late-stage development. This position will require a highly motivated and independent leader who can effectively collaborate with team members across the organization to advance projects. This position will be hired as a hybrid position, with on-site presence at Zoetis VMRD headquarters in Kalamazoo, Michigan required ≥50% of the time.

Requirements

  • 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.
  • Skilled in the used 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.

Nice To Haves

  • Experience with biotherapeutics (protein therapeutics) is highly desirable.
  • 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.

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.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

Ph.D. or professional degree

Number of Employees

5,001-10,000 employees

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