Zoetis is seeking an experienced pharmacokinetics-pharmacodynamics scientist to join our industry leading research and development team. This position requires a highly motivated and independent leader responsible for the design, conduct, analysis, and interpretation of in vivo PK/PD studies of protein therapeutics in multiple species. The successful candidate will need to have excellent interpersonal and communication skills and will work in multidisciplinary teams to develop novel veterinary therapeutics from early research through late-stage development.
- Independently design, conduct and analyze in vivo PK/PD, PK and TK studies in multiple veterinary species for large molecule (protein) therapeutics. May also assist with small molecule pharmaceutical studies.
- Design studies and interpret ADA assay results to evaluate the immunogenicity of protein therapeutics.
- Serve as study director or principal investigator for in vivo PK, PK/PD, TK or clinical studies (GxP and non-GxP), including writing protocols and reports.
- Collaborate with bioanalytical team to forecast analytical requirements for projects and assess performance of analytical assays (immunoassays and LC/MS assays)
- Provide PK and PK/PD modeling and simulation to help select lead candidates and optimize dose regimens
- Work collaboratively with multidisciplinary teams to prosecute studies and projects in line with the strategic direction of the team
- 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
EDUCATION AND EXPERIENCE:
- PhD in Pharmacology, Biochemistry, or related discipline. Five (5) years or more of industry experience in PK/PD required.
- Demonstrated 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 or Watson. Experience in PK/PD modeling and simulation is highly desirable.
- Highly independent scientist with strong background in ADME and immunogenicity of protein therapeutics.
- Solid background in statistics and experience with SAS, JMP and/or R is highly desirable.
- Excellent verbal/written communication, organizational and interpersonal skills
- Self-starter, able to prioritize work and work efficiently with minimal supervision
- Working knowledge of analytical methodology for large molecule and small molecule analyses, including ligand binding assays (immunoassays) and LC/MS/MS assays.
- Experience interacting with regulatory agencies is highly desirable
- Experience conducting GLP studies is desirable