AbbVie Associate Director, Director Clinical Pharmacokinetics in Lake County, Illinois

Description:
The Clinical Pharmacology and Pharmacometrics (CPPM) Organization 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.

We have an exciting opportunity for an Associate Director,Director Pharmacokinetics, Immunology Therapeutic Area based in North Chicago, IL

Key Responsibilities Include:

•Provides expert Clinical Pharmacokinetic (PK)/Pharmacodynamic (PD)/Clinical Pharmacology strategic input to R&D, Regualtory Affairs, Medical Affairs, and all levels of CPPM management on critical decisions •Responsible project reviews and for critically evaluating technical and scientific aspects of Clinical PK/PD projects/programs with CPPM Management •Participates in the management of multiple goals/responsibilities and development plans for multiple projects within or across multiple therapeutic areas (TAs) •Conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve Clinical Pharmacology goals and regulatory requirements for multiple functions •Independently conducts scientific due diligence on compounds •Anticipates and critically evaluates Clinical Pharmacology and/or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies •Responsible for leading Clinical Pharmacology/PK/PD aspects •Serves as Clinical PK/PD liaison to other departments for studies and multiple projects •Manages of one or more Clinical Pharmacology programs •Independently leads PK/PD activities and multiple major projects across multiple projects •Provides critical interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submission •Is the primary author in high-impact factor peer-reviewed journals, R&D reports, and/or regulatory documents/filings •Analyzes the impact of PK/PD decisions across multiple projects •Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact) and competitive information •Develops productive collaborations and communications with other groups across multiple disciplines

Qualifications:
Position will be hired based on level of experience:

For Associate Director •PhD in related field
•6 years of experience in the pharmaceutical industry or equivalent •Experience in multiple therapeutic areas or disease state/indications •Knowledge and understanding in application of Clinical Pharmacology business procedures and of clinical trial methodology, applicable regulatory guidances, global regulations, ethical issues associated with clinical studies, SOPs •Proven track record of successful projects (report/submissions delivered on time, high quality) •Participated in and is key contributor to initiatives and advancement of CPPM as an organization •Advanced knowledge of and experience in multiple therapeutic and/or functional areas. Experience across range of development phases preferred •Must have demonstrated exemplary PK/PD experience in managing and completing multiple complex projects within Clinical Pharmacology or equivalent experience •Must have demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple projects

For Director, Clinical Pharmacokinetics

  • PhD in related field
  • Typically 8 yrs experience in the pharmaceutical industry or equivalent,
  • Substantial understanding in multiple therapeutic areas or disease state/indications
  • Knowledge and understanding in application of R&D business procedures and of clinical trial methodology, applicable regulatory guidances, global regulations, ethical issues associated with clinical studies, SOPs
  • Proven track record of successful projects (report/submissions delivered on time, high quality) in a cross functional team environment
  • Participated in and is key contributor to initiatives and advancement of CPPM and R&D or equivalent
  • Advanced knowledge of and experience in multiple therapeutic and/or functional areas. 
  • Experience across range of development phases
  • Must have demonstrated experience in managing and completing multiple complex projects within CPPM or equivalent experience
  • Must have demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple complex projects and one or more TAs   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 the course quickly where indicated •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

Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Organization: Research & Development
Schedule: Full-time
Shift: Day
Travel: Yes, 5 % of the Time
Req ID: 1607719

Equal Opportunity Employer Minorities/Women/Veterans/Disabled