Senior Level PK/PD Position

From: Joseph F Boucher Date: February 19, 2016 job Source: mail-archive.com
Zoetis - a global animal health company dedicated to supporting its customers and their businesses. Location: Kalamazoo, Michigan Pharmacokinetic-Pharmacodynamics Associate Research Director/Research Director Position Summary We are seeking a talented senior scientific leader to join our team to discover 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. Specifically, we are looking for a senior PK/PD leader to provide technical scientific leadership in pharmacokinetics, pharmacodynamics, bioanalytical and translational sciences for early research and late stage development projects. This position will be primarily responsible for support of large molecule protein therapeutic projects, but will also need to provide some support for small molecule projects. This position will require supervisory responsibilities of scientific colleagues. Responsibilities * Independently design, conduct and analyze analytical data for in vivo TK, PK and PK/PD studies in multiple veterinary species for large molecule and small molecule therapeutics which are appropriate to support regulatory submissions * Provide PK/PD modeling, bioanalytical and translational science guidance to projects to help select lead candidates and optimize dose regimens * Supervise, train and mentor other scientists supporting large molecule and small molecule therapeutic projects * Work collaboratively with interdisciplinary teams to prosecute studies and projects in line with the strategic direction of the team * Serve as study director or principal investigator, including writing protocols and reports for in vivo studies, including GLP studies * Present 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 Minimum Qualifications * PhD in Pharmacology, Biochemistry, or related discipline with a minimum of 12 years of industry experience in PK/PD, bioanalytical and/or translational sciences of small or large molecules. * Demonstrated ability to provide PK/PD modeling support for in vivo studies, preferably in the area of large molecule protein therapeutics, with a proven track record of success including peer reviewed publications. * Experience with GLP regulated studies * Expert user of PK/PD modeling software such as WinNonlin, NONMEM, etc. * Highly independent with the ability to innovate within the discipline * Excellent written and oral communication skills * Working knowledge of analytical methodology for large molecule and small molecule analyses, including ligand binding assays (immunoassays) and LC/MS/MS assays. * Familiarity of immunogenicity risk assessments, testing and interpretation for large molecule therapeutics. Desirable skills * Working knowledge of principles and concepts in adjacent disciplines for biotherapeutic projects (toxicology, formulation, molecular biology, protein expression/purification) * Experience developing population PK models and/or evaluating PK variance in clinical populations * Experience with radiolabeled (14C and/or 3H) drug disposition studies * Experienced with LIMS software, such Watson. * Experienced with monitoring work at CROs Apply at Zoetis.com Position: JR00000911