Senior Clinical Pharmacologist

4 weeks ago

North Chicago, United States AbbVie, Inc Full time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Key Responsibilities

* 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.

Qualifications

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:

* physicochemical properties as related to drug delivery & preclinical & clinical formulation design, as well as physiological barriers to drug absorption, including various potential transport mechanisms;
* designing & performing diverse in vitro & ex vivo assays to evaluate absorption & other development potential;
* analytical techniques & typical equipment utilized for physicochemical characterization of small-molecule candidates (e.g., HPLC, DSC, TGA, PXRD, drug release testing);
* 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; &
* PBBM/PBPK & compartmental analysis to interpret pharmacokinetic data & perform oral absorption modeling.

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