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Sr. Scientist

Company: AbbVie
Location: Irvine
Posted on: November 19, 2021

Job Description:

About AbbVieAbbVie'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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .Overview: The Clinical Pharmacology group, as part of Research, Nonclinical and Translational Sciences (RNTS) at AbbVie, is seeking a Senior Scientist - Modeling and Simulation. As a member of multidisciplinary teams, this individual will contribute both Pharmacokinetic and Modeling and Simulation (M&S) expertise to lead efforts to build in silico drug models that describe the relationship(s) between exposure (drug, antibody, biomarker) and response (pharmacodynamic, toxicodynamic) for both desired and undesired effects. These models will support early stage clinical development activities utilizing various sources of data from both nonclinical models and humans. This individual will have a strong background and expertise in pharmacokinetics and biopharmaceutics including IVIVC modeling, PBPK modeling, and exposure-response modeling in drug development. This individual should be comfortable with exploratory analyses and non-conventional modeling beyond systemic drug development including ophthalmology, neurotoxin, and aesthetics/dermatology. This scientist should be proactive, inquisitive, a self-starter who is eager to learn and thrives in a fast pace and independent environment, with a desire to interact as a modeling and simulation expert with matrix project teams. Specific responsibilities include:

  • Apply PK, PK/PD, PBPK, IVIVC modeling/simulation to guide the design and execution of in vivo preclinical animal experiments and/or early stage clinical trials.
  • Identify opportunities to apply and develop modeling and simulation strategies across the R&D portfolio, with a focus on ophthalmology, neurotoxin, and aesthetics/dermatology.
  • Integrate M&S knowledge to contribute to optimizing clinical pharmacology strategies.
  • Analysis of PK/PD data, both clinical and nonclinical, through the use of sophisticated mathematical and statistical modeling and simulation tools to support dose selection, study design and proof-of-concept.
  • Identify and monitor vendors and consultants or engage internal resource as appropriate to meet project deliverables.
  • In collaboration with other stakeholders, conduct and integrate data analyses and summarize modeling outcomes to support IND, CTA, IMPD, NDA, and BLA filing and regulatory correspondences.
  • Exploratory analyses and non-conventional modeling beyond systemic drug development with a focus on locally administered/acting products.
  • Maintain awareness of current technologies in pharmacometics.
  • Develop close and effective partnerships with other nonclinical and clinical pharmacology/PKPD and biomarker scientists, safety scientists, research scientists, clinicians and project teams. QualificationsEducation and Experience
    • Ph.D., in Pharmaceutical Sciences, Quantitative Pharmacology, Biomedical/Chemical Engineering, Pharmacometrics or related field, or Pharm.D. with 2-5 years of experience in IVIVC, PK/PD modeling & simulation, quantitative pharmacology, and/or applied population PK in the pharmaceutical industry. Post-doctoral experience in an academic lab focused on training pharmacometricians will also be considered. Job role/title is commensurate with experience and capabilities.
    • Academic and/or industry experience in either physiologically based pharmacokinetic (PBPK) modeling or population PK/PKPD modeling.
    • Strong knowledge of biology (mechanism of action)/pharmacology, toxicology, clinical immunology, protein sciences, statistics, and pharmaceutical development
    • Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop models.
    • Data manipulation and programming skills and ideally with the use of programs such as SAS, R, S+ or similar programs.
    • Experience using Phoenix WNL, GastroPlus
    • Scientific publications in area of specialization.
      • Effective written and verbal communication skills.
      • Strong ability to collaborate with others.
      • Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of modeling.
      • The successful candidate is required to have ability to work within a diverse workforce. Preferred Experience
        • Experience with development of sustained release formulations and/or biologics
        • Experience with general programming and data analysis tools/languages such as R, Matlab, Berkeley Madonna, ADAPT, etc. Significant Work ActivitiesN/ATravelNoJob TypeExperiencedScheduleFull-timeJob Level CodeICEqual Employment OpportunityAt AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.

Keywords: AbbVie, Irvine , Sr. Scientist, Other , Irvine, California

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