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.
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.
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.
Position will be hired based on level of experience and may be hired at a lower level
PhD with 0 years of experience, or Pharm D with 2+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 8+ years of experience, Bachelor’s Degree or equivalent education and typically 10+ years of experience; (*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 settingDemonstrates scientific acumen and has technical skills to perform the roleKey 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
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.