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PK/PD Principal Scientist
Apply locations Zaventem time type Full time posted on Posted Yesterday job requisition id JR00018580
The Zoetis Veterinary Medicine Research & Development (VMRD) is seeking a talented PK/PD scientist to join our team to discover and develop novel protein 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 biotherapeutics (protein therapeutics) projects from early research through late-stage development. This position will require a highly motivated and independent leader who can effectively collaborate with other team members to advance projects.
POSITION 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.
• Evaluate Anti-Drug Antibody (ADA) assay results and assess immunogenicity of biotherapeutic candidates in multiple veterinary species.
• Collaborate with 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 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.
REQUIRED EDUCATION AND EXPERIENCE:
• 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. Experience with biotherapeutics (protein therapeutics) is highly desirable.
• Skilled in the used of PK and PK/PD analysis software such as WinNonlin, Monolix or Watson.
• Knowledge of ADA assays and how results are used to assess immunogenicity of biotherapeutics.
• Experience in PK/PD modeling and simulation such as PBPK, QSP or population PK modeling using NONMEM, R, or related software is highly desirable.
• Must have excellent verbal & written communication skills.
• Self-starter, able to prioritize work and work efficiently with minimal supervision.
• Working knowledge of bioanalytical methodology.
• Experience interacting with regulatory agencies is highly desirable.
• Experience conducting GLP studies is desirable.
Full time
About Us
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues’ careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.
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