at AbbVie US LLC in North Chicago, Illinois, United States
Job Description
Senior Clinical Pharmacologist, AbbVie Inc., North Chicago, Illinois. Conceive & execute novel scientific research of development in Clinical Pharmacology that achieves projects & Clinical Pharmacology & Pharmacometrics (CPPM) goals. Generate new PK/PD proposals & lead those efforts. Investigate, identify, develop, & optimize new methods & techniques in PK/PD field. Act as lead PK scientist in their area of expertise & critically evaluate relevant Clinical Pharmacology, PK/PD & regulatory advances & integrate this knowledge into research or development programs. Employ understanding of physicochemical properties as related to drug delivery & preclinical & clinical formulation design, as well as physiological barriers to drug absorption, including various potential transport mechanisms. Contribute to clinical development by supporting Phase 1-4 studies including study design, & clinical pharmacology strategy. Design & perform diverse in vitro & ex vivo assays to evaluate absorption & other development potential. Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, relevant section of investigator brochures, common technical documents, white papers, & other similar documents. Conduct data analyses including noncompartmental analyses, modeling & simulation, literature data analyses. Employ experience with analytical techniques & typical equipment utilized for physicochemical characterization of small-molecule candidates (e.g., HPLC, DSC, TGA, PXRD, drug release testing). Participate & present at various departmental & cross functional teams such as study teams, clinical pharmacology & biopharmaceutics, clinical strategy team, CPPM leadership team, journal club. Perform data analysis in order to conduct analysis & interpretation of trends in large data sets by utilizing statistical tools such as Python Pandas & Microsoft Excel. Employ experience with PBBM/PBPK & compartmental analysis to interpret pharmacokinetic data & perform oral absorption modeling. Collaborate with scientific support from other CPPM functional groups to provide unified clinical pharmacology position to clinical, CMC & regulatory teams. Author scientific publications & present at scientific conferences. Must possess PhD or foreign academic equivalent in Pharmaceutical Science, Pharmaceutical Chemistry, Chemistry, Chemical Engineering or a highly related field of study with an academic or industrial background in the following: (i) physicochemical properties as related to drug delivery & preclinical & clinical formulation design, as well as physiological barriers to drug absorption, including various potential transport mechanisms; (ii) designing & performing diverse in vitro & ex vivo assays to evaluate absorption & other development potential; (iii) analytical techniques & typical equipment utilized for physicochemical characterization of small-molecule candidates (e.g., HPLC, DSC, TGA, PXRD, drug release testing); (iv) performing data analysis in order to conduct analysis & interpretation of trends in large data sets by utilizing statistical tools such as Python Pandas & Microsoft Excel; & (v) PBBM/PBPK & compartmental analysis to interpret pharmacokinetic data & perform oral absorption modeling. Apply online at https://careers.abbvie.com/en & reference REF23206B.