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Director, Quantitative System Medicine, Clinical Pharmacology and PharmacometricsUSA, Illinois, Lake CountyNewResearch & DevelopmentRequisition #2002484Purpose: The Pharmacometrics/Quantitative Systems Medicine group with Clinical Pharmacology and Pharmacometrics is searching for a scientist to lead Physiologically Based Pharmacokinetic Modeling (PBPK) and Quantitative Systems Pharmacology (QSP) Modeling at AbbVie. The scientist will develop and apply PBPK modeling for molecules in clinical development with a focus on supporting internal business questions and regulatory filings. In addition, the application of QSP methods will enable early predictions of trial outcomes by leveraging all available data from in-house and literature sources to aid in trial design, biomarker methods, and patient selection. The scientist will lead a team of scientists to leverage and apply these methods across AbbVie’s development portfolio. The scientist establishes strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives and utilizes scientific expertise to provide appropriate interpretation and of data and relates implications of results to management. The scientist will communicate / present key Clinical Pharmacology information / strategy to senior and executive management, regulatory agencies, and external peers. The scientist will serve as a liaison to other departments /divisions for any study/project needs and influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions.Responsibilities:
Develops and implements strategies to apply PBPK, PBBM and QSP/PMX modeling and simulation to clinical pharmacology development plans across therapeutic areas
Identify opportunities to support clinical development projects (e.g. Phase 1 clinical pharmacology study design and prioritization, clinical study waivers, etc.) using state of the art PBPK and QSP modeling and simulations
Leads cross functional collaborations within clinical pharmacology and pharmacometrics to enable optimal project support using model-informed drug development strategies
Leads cross functional collaborations with CMC, regulatory CMC and Drug Product Development and develop strategies to apply PBPK modeling and simulation for biopharmaceutics applications (e.g. justification of dissolution specifications, virtual bioequivalence, quality by design applications, formulation changes and impact on in vivo bioavailability, etc.)
Leads cross functional collaborations with Drug Metabolism and Pharmacokinetics (DMPK) to apply PBPK modeling and simulation for DDI assessment
Builds strong external network and visibility through active participation in consortia, publications and pre-competitive collaboration
Up to date on recent scientific literature in the fields of PBPK, PBBM, and QSP modeling and simulation
Leads teams within department, across CPPM and across functions. Responsible for leadership of cross-functional teams and accountable for effective performance of the team
Actively manages project team behaviors, mediates internal team disputes, and facilitates establishment of healthy and high performing teams.
Manages personnel including development, mentoring, and effective delegation
Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship
PhD with 7+ years or PharmD with 9+ years of experience in developing and applying PK, PK/PD, PBPK and/or QSP modeling to support translational and clinical research
Excellent interpersonal skills, strong communication and ability to clearly convey strategies to leadership and cross functional partners
PhD in the fields of Pharmacology, Pharmacokinetics, Pharmaceutics, Bioengineering, Pharmacometrics (PMX) or related fields, including Computer Science, Applied Mathematics
High expertise and leadership in the fields of PBPK, PBBM and QSP/PMX modeling and simulation, including competency in numerical analysis focusing on differential equations and parameter optimization
Knowledge of drug development and experience impacting key decisions using modeling and simulation, including broad knowledge in PKPD, ADME and biopharmaceutics of small and large molecules in multiple therapeutic and/or functional areas. Experience across range of development phases.
Strong background in the theory of pharmacokinetics and pharmacodynamics, ADME biology and physiological processes
Demonstrated success in PBPK, PBBM and QSP/PMX modeling and simulation for clinical project support and regulatory filing/approvals
Experience developing, calibrating and verifying PBPK and QSP models with expertise in scientific computing and programming using available software packages (e.g., Matlab and Simbiology, SimCYP, Gastroplus, PKsim, R, R Studio, etc.)
Must have demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple complex projects
Demonstrated project management skills such as scope management, progress tracking/driving as well as people leadership and time management skills
Key Leadership Competencies: Knows the business and the cross-functional contributions needed to deliver results Delivers business results while also positioning AbbVie for long-term success Manages conflict and difficult conversations in a constructive transparent way Develops direct reports and capable successors through coaching, stretch assignments and learning opportunities Sets clear goals that challenge direct reports to raise the bar on performance Respectfully provides transparent, accurate and timely feedback to help direct reports improve performance Creates an inclusive environment where all direct reports can succeed
Additional Information
Significant Work Activities and Conditions: Keyboard use (greater or equal to 50% of the workday), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
Job Level Code: D
Vacancy expired!