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.
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
