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.
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.
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.
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
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 (https://www.abbvie.com). Follow @abbvie on Twitter (https://twitter.com/abbvie), Facebook (https://www.facebook.com/AbbVieGlobal), Instagram (https://www.instagram.com/abbvie/?hl=en), YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie).