PK/PD Principal Scientist
Zoetis
5 hours ago
Remote friendly (Michigan, United States)
United States
Clinical Research and Development
Position Responsibilities:
- 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 select lead candidates and optimize dose regimens.
- Collaborate with bioanalytical teams to assess analytical assay suitability and forecast analytical requirements.
- Lead scientific strategy across therapeutic areas focused on mechanistic platforms/biomarkers for translation, target engagement measurement, and dose predictions.
- Collaborate and communicate with multidisciplinary teams to design and execute studies per project strategy.
- Present research results to scientific teams, management, and regulatory agencies.
- Write sections of regulatory submissions, respond to regulatory inquiries, and maintain knowledge of regulatory guidance documents.
Required Education and Experience:
- Ph.D in pharmacology, biochemistry, or related field with 4+ years relevant pharmaceutical development experience. DVM DACVCP or DVM Dipl. ECVPT highly desirable.
- Proven ability to design, analyze, and interpret in vivo PK and PK/PD studies; biotherapeutics (protein therapeutics) experience highly desirable.
- Proficiency with PK/PKPD analysis software such as WinNonlin, Monolix, or Watson.
- Excellent verbal and written communication skills.
- Self-starter; prioritize work and work efficiently with minimal supervision.
- Working knowledge of bioanalytical methodology.
- Knowledge of ADA assays and assessment of biotherapeutic immunogenicity highly desirable.
- PK/PD modeling and simulation experience (e.g., PBPK, QSP, population PK modeling using NONMEM, R, or related tools) highly desirable.
- Experience interacting with regulatory agencies highly desirable.
- Experience conducting GLP studies desirable.
Benefits (explicitly stated):
- US base salary range: $114,000 - $185,000; eligible for short-term and long-term incentives.
- Healthcare and insurance benefits beginning on day one; 401K plan with match and profit-sharing; 4 weeks of vacation.
Application instructions:
- Not provided in the text.
- 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 select lead candidates and optimize dose regimens.
- Collaborate with bioanalytical teams to assess analytical assay suitability and forecast analytical requirements.
- Lead scientific strategy across therapeutic areas focused on mechanistic platforms/biomarkers for translation, target engagement measurement, and dose predictions.
- Collaborate and communicate with multidisciplinary teams to design and execute studies per project strategy.
- Present research results to scientific teams, management, and regulatory agencies.
- Write sections of regulatory submissions, respond to regulatory inquiries, and maintain knowledge of regulatory guidance documents.
Required Education and Experience:
- Ph.D in pharmacology, biochemistry, or related field with 4+ years relevant pharmaceutical development experience. DVM DACVCP or DVM Dipl. ECVPT highly desirable.
- Proven ability to design, analyze, and interpret in vivo PK and PK/PD studies; biotherapeutics (protein therapeutics) experience highly desirable.
- Proficiency with PK/PKPD analysis software such as WinNonlin, Monolix, or Watson.
- Excellent verbal and written communication skills.
- Self-starter; prioritize work and work efficiently with minimal supervision.
- Working knowledge of bioanalytical methodology.
- Knowledge of ADA assays and assessment of biotherapeutic immunogenicity highly desirable.
- PK/PD modeling and simulation experience (e.g., PBPK, QSP, population PK modeling using NONMEM, R, or related tools) highly desirable.
- Experience interacting with regulatory agencies highly desirable.
- Experience conducting GLP studies desirable.
Benefits (explicitly stated):
- US base salary range: $114,000 - $185,000; eligible for short-term and long-term incentives.
- Healthcare and insurance benefits beginning on day one; 401K plan with match and profit-sharing; 4 weeks of vacation.
Application instructions:
- Not provided in the text.