PK/PD Principal Scientist

Job Description

Independently lead the design and analysis of in vivo PK/PD, PK, and TK studies across various veterinary species. Responsibilities include crafting detailed study protocols and comprehensive reports. Utilize PK and PK/PD modeling and simulation techniques to aid in selecting promising lead candidates and refining optimal dose regimens. Collaborate closely with the bioanalytical team to evaluate the suitability of analytical assays and anticipate analytical requirements for ongoing projects. Spearhead the advancement of scientific strategies across different therapeutic areas, emphasizing mechanistic platforms and biomarkers to facilitate translation, assess target engagement, and predict effective dose regimens. Work collaboratively and communicate effectively within multidisciplinary teams to design and execute studies that align with the overarching strategic goals of the project. Present research findings to scientific teams, management, and regulatory agencies. Author sections of regulatory submissions, address inquiries from regulatory agencies, and stay informed about current regulatory guidance documents.

Qualifications

1. Hold a Ph.D. in pharmacology, biochemistry, or a closely related field. 2. Possess a minimum of 4 years of relevant pharmaceutical development experience. 3. Demonstrate a proven ability to design, analyze, and interpret in vivo PK and PK/PD studies. 4. Experience with biotherapeutics, especially protein therapeutics, is highly advantageous. 5. Proficiency in using PK and PK/PD analysis software such as WinNonlin, Monolix, or Watson. 6. Exhibit excellent verbal and written communication skills. 7. Be a self-motivated individual capable of prioritizing tasks and working efficiently with minimal supervision. 8. Possess a working knowledge of bioanalytical methodology. 9. Knowledge of ADA assays and assessment of immunogenicity of biotherapeutics is highly desirable. 10. Experience in PK/PD modeling and simulation, including PBPK, QSP, or population PK modeling using NONMEM, R, or related software, is highly desirable. 11. Experience interacting with regulatory agencies is highly desirable. 12. Experience conducting GLP studies is desirable.

Benefits

- Comprehensive healthcare and insurance benefits starting on day one. - A 401K plan with both a company match and profit-sharing contribution from Zoetis. - Enjoyable 4 weeks of vacation time.