PK/PD Senior Scientist
Zoetis
6 hours ago
Remote friendly (Michigan, United States)
United States
Clinical Research and Development
POSITION RESPONSIBILITIES:
- 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 help select lead candidates and optimize dose regimens.
- Collaborate with the bioanalytical team to assess 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 project’s strategic direction.
- 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.
REQUIRED EDUCATION AND EXPERIENCE:
- Ph.D in pharmacology, pharmaceutical sciences, biochemistry, or related field. 2–4 years of post-doctoral experience in pharmaceutical development is highly desirable.
- DVM DACVCP or DVM Dipl. ECVPT is highly desirable.
REQUIRED / DESIRED QUALIFICATIONS & SKILLS:
- Proven ability to design, analyze and interpret in vivo PK and PK/PD studies; experience with biotherapeutics (protein therapeutics) is highly desirable.
- Skilled in PK/PK/PD analysis software such as WinNonlin, Monolix or Watson.
- Excellent verbal and written communication skills.
- Self-starter; able to prioritize work and work efficiently with minimal supervision.
- Working knowledge of bioanalytical methodology.
- Experience with PK/PD modeling and simulation (e.g., PBPK, QSP, or population PK modeling using NONMEM, R, or related software) is highly desirable.
- 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 help select lead candidates and optimize dose regimens.
- Collaborate with the bioanalytical team to assess 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 project’s strategic direction.
- 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.
REQUIRED EDUCATION AND EXPERIENCE:
- Ph.D in pharmacology, pharmaceutical sciences, biochemistry, or related field. 2–4 years of post-doctoral experience in pharmaceutical development is highly desirable.
- DVM DACVCP or DVM Dipl. ECVPT is highly desirable.
REQUIRED / DESIRED QUALIFICATIONS & SKILLS:
- Proven ability to design, analyze and interpret in vivo PK and PK/PD studies; experience with biotherapeutics (protein therapeutics) is highly desirable.
- Skilled in PK/PK/PD analysis software such as WinNonlin, Monolix or Watson.
- Excellent verbal and written communication skills.
- Self-starter; able to prioritize work and work efficiently with minimal supervision.
- Working knowledge of bioanalytical methodology.
- Experience with PK/PD modeling and simulation (e.g., PBPK, QSP, or population PK modeling using NONMEM, R, or related software) is highly desirable.