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AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Clinical Pharmacologist

Lake County, Illinois Req ID 2110184 Category Research and Development Division AbbVie

Overview: 

The Clinical Pharmacology and Pharmacometrics Organization (CPPM) leads the strategy, generation/analyses/interpretations/reporting of data and communications/agreements with global regulatory agencies in the areas of Clinical Pharmacology, Pharmacokinetics, Exposure-Response and Biopharmaceutics.

 

The organization supports all phases of pharmaceutical research and development from Discovery to Development to On Market Support for all new molecular entities and marketed products in all therapeutic areas (antiviral, immunoscience, neuroscience, pain, metabolic disease, men and women’s health, renal disease and oncology).

 

The organization is responsible for defining the relationship between drug exposure (e.g., concentrations in blood) and efficacy measures (primary and/or secondary clinical outcomes or biomarkers) to select the optimal dose and dosing intervals. CPPM is also responsible for defining the relationship between drug exposure and safety measures (clinical outcomes or biomarkers (e.g., QTc)) to identify populations that may be at risk of increased toxicity or decreased tolerability. 

 

CPPM performs the selection, design and interpretation of all Phase I studies including first in human, bioavailability/ bioequivalence/food effect, drug interaction, pilot/definitive cardiovascular (QTc), special population, pharmacogenetic and immunogenicity studies.

 

The organization provides critical support for conducting technical due diligence of new business opportunities (both in-licensing and out-licensing) by assessing probability of success for achieving Target Product Profile (TPP). CPPM contributes to responses to defend our intellectual properties and extension of patent protection, provides critical support for life-cycle management of marketed products, responds to questions from post-marketing safety, legal, pharmaceutical manufacturing and regulatory for  marketed products world-wide, and publication of scientific information in patents and manuscripts. The Clinical Pharmacology and Pharmacometrics Organization (CPPM) leads the strategy, generation/analyses/interpretations/reporting of data and communications/agreements with global regulatory agencies in the areas of Clinical Pharmacology, Pharmacokinetics, Exposure-Response and Biopharmaceutics.

 

Purpose Statement:
Conceive and execute novel scientific research or development in Clinical Pharmacology that achieves projects and Clinical Pharmacology and Pharmacometrics (CPPM) goals. Generate new PK/PD
proposals and lead those efforts. Investigate, identify, develop, and optimize new methods and techniques in PK/PD field. Act as a lead PK scientist in his/her area of expertise and critically evaluate relevant Clinical
Pharmacology, PK/PD and regulatory advances and integrate this knowledge into research or development programs.
 
Responsibilities:
  • Contribute to clinical development by supporting Phase 1-4 studies including study design, and clinical pharmacology strategy.
  • Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, relevant section of investigator brochures, common technical documents, white papers, and other similar documents.
  • Conduct data analyses including non-compartmental analyses, modeling and simulation, literature data analyses.
  • Participate and present at various departmental and cross functional teams such as study teams, clinical pharmacology and biopharmaceutics, clinical strategy team, CPPM leadership team, Journal club.
  • Collaborate with scientific support from other CPPM functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
  • Author scientific publications and present at scientific conferences.
Qualifications:

Position will be hired based on level of experience and may be hired at a lower level

Qualifications:
  • PhD with 0-3 years of experience or Pharm D with 2-5 years of experience in a relevant field*; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
  • Excellent interpersonal skills
  • Ability to interact externally and internally and perform in a team setting
  • Demonstrates scientific acumen and has technical skills to perform the role
  • Key Leadership Competencies: Persistent and resilient finds the way to move good ideas forward; Uses mistakes, failure and reflection as vehicles for learning and improvement; Delivers business results while also positioning AbbVie for long-term success; Connects unrelated concepts, generates original or unique ideas; Influences colleagues to achieve cross-functional alignment
 
Significant Work Activities: N/A
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
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