PK/PD Principal Scientist
📋 Role Overview & Responsibilities
The Zoetis Veterinary Medicine Research & Development (VMRD) is seeking a talented pharmacokinetic/ADME scientist to join our team to discover and develop novel therapeutics for veterinary medicine. This position will require a highly motivated and independent leader who can effectively collaborate with other team members to advance projects. 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. POSITION RESPONSIBILITIES:Independently design, conduct and analyze in vivo PK/PD, PK and TK studies in multiple veterinary species.Assess immunogenicity of biotherapeutic candidates in multiple veterinary speciesServe as study director or principal investigator for in vivo PK, PK/PD, TK or clinical studies (GxP and non-GxP), including writing protocols and reports.Collaborate with bioanalytical team to forecast analytical requirements for projects and assess performance of analytical assays.Provide PK and PK/PD modeling and simulation to help select lead candidates and optimize dose regimens.Work collaboratively with multidisciplinary teams to prosecute studies and projects in line with the strategic direction of the team.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 pharmaceutics, pharmacology, biochemistry, or related field with 2 or more years of relevant pharmaceutical development experienceAbility to design, analyze and interpret in vivo PK and PK/PD studies. Experience with biotherapeutics (protein therapeutics) is highly desirable.Interpret ADA assay results to assess immunogenicity of biotherapeutics.Skilled in the used of PK and PK/PD analysis software such as WinNonlin, Monolix or Watson. Experience in PK/PD modeling and simulation is highly desirable.Excellent verbal & written communication, organizational and interpersonal skills.Independent scientist with strong background in ADME.Self-starter, able to prioritize work and work efficiently with minimal supervision.Working knowledge of bioanalytical methodology.Experience with NOMEM, SAS, JMP and/or R is highly desirable.Experience interacting with regulatory agencies is highly desirable.Experience conducting GLP studies is desirable.
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This position is located in Kalamazoo, MI with potential relocation and sponsorship assistance depending on candidate qualifications.
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