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About AbbVie

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.

Associate Director, Clinical Pharmacology

Irvine, California Req ID 2207006 Category Research and Development Division AbbVie

The Clinical Pharmacology group, as part of Research, Nonclinical and Translational Sciences (RNTS) at AbbVie, is searching for an Associate Director to provide project support, informing decision-making in both small and large molecule, novel drug delivery platform projects from Discovery to Development to On Market Support.  Scope of work includes preclinical PK/PD, clinical PK/PD, clinical pharmacology (CP), immunogenicity, and target engagement strategy for assets in eyecare, aesthetics, and neurotoxin portfolios.  The candidate will also establish innovative modeling approaches to enable translation from animal to human.

 

Key Responsibilities:

  • Design and provide scientific oversight of preclinical PK/TK studies and Clinical Pharmacology studies
  • Conduct data analyses including non-compartmental analyses, modeling and simulation, literature data analyses.
  • Liaise with research, toxicology, immunology, bioanalytical, and clinical development colleagues to generate data and knowledge supporting the development and implementation of translational models
  • At project level, establish and maintain effective collaborations with key stakeholders to facilitate data integration for biomarker selection, candidate nomination/selection, human dose prediction and FIH study design, and late-stage clinical development dose selection
  • Participate and present at various departmental and cross functional teams.
  • Author regulatory documents including protocols, study reports, exposure-response analyses reports, relevant section of investigator brochures, common technical documents, white papers, and other similar documents.
  • Maintain awareness of emerging literature and science in PK/Clinical Pharmacology specific to eyecare, aesthetics, and neurotoxin.
  • Author scientific publications and present at scientific conferences.
  • Mentor junior Clinical Pharmacology colleagues, fellows, and interns. 
Qualifications:

Basic Qualifications:

  • Doctorate (Ph.D. in chemical or biomedical engineering; applied mathematics; quantitative pharmaceutical sciences or a related field or Pharm.D.), with 5+ years of post-graduate work experience

 

  • Level and compensation will be commensurate with experience
  • Hands-on experience with relevant modeling software and programming languages including MATLAB/Simbiology, R, Python, WinNonLin/Phoenix, etc. is desired
  • Understanding of small or large molecule drug modalities and relevant analytical methods for measuring drug and biomarker levels in preclinical and clinical study samples is required
  • Publication record demonstrating PK/PD or systems modeling examples is highly desired
  • Must have strong communication skills and the ability to effectively communicate with both internal and external stakeholders, and to audiences of diverse backgrounds
  • Highly motivated, self-driven and results-oriented person, capable of both leading and being lead
  • High degree of flexibility in adapting to different projects and personalities as well as excellent networking and relationship-building skills (both internal and external) required
  • Passion for data analysis, solving technical problems and applying new technologies to further scientific goals and answer key scientific questions enabling data informed decision-making
  • Additional prior experience in an experimental in vitro or in vivo biology field is desired

 

Key Leadership Competencies:

  • Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance
  • Learns fast, grasps the "essence" and can change course quickly when necessary
  • Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, open to suggestions and experimentation for improvement
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality

 

**Equal Opportunity Employer Minorities/Women/Veterans/Disabled**

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
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