AbbVie Inc
Associate Director, PBPK Modeling (Onsite IL; Hybrid)
This job is now closed
Job Description
- Req#: 57035579264
This position sits onsite 3 days weekly (2 days remote) at our North Chicago, IL headquarters
Purpose:
The Associate Director, PBPK Modeling leads modeling and simulation projects and strategies (PBPK, systems pharmacology, and/or pharmacometrics) to drive organizational impact while mentoring/supervising junior team members in the realization of analysis plans.
Responsibilities:
• Leads mechanistic modeling projects and strategies (including PBPK models and PD models) that achieve project and therapeutic area goals, using state of the art software platforms to inform disease pathway assessments, translation to inform disease pathway assessments, translation to special populations, precision medicine, DDI risk assessments, and/or biopharmaceutics applications
• Develops seamless integration plans and best practices for implementation of modeling and simulation along with data management, version control, and quality control
• Writes, communicates, and presents PBPK and/or system pharmacology materials, strategies and techniques; presents modeling and simulation materials in reports and internal/external meetings
• Interacts with AbbVie thought leaders and program leads on the effective use of these tools to further the development and approval of new drug candidates
• Interfaces with pre-clinical scientists, process scientists, formulation groups, and regulatory departments on the effective use of modeling and simulations to develop drug dissolution methods, quality control methods, formulation design, and virtual bioequivalence testing using innovative modeling solutions
• Contributes to the development of commercial and regulatory strategies by formulating modeling plans including development activities
• Develops regulatory submission strategies for modeling & simulation and participates in regulatory interactions, communications, and responses
• Authors external publications, project reviews, reports and/or regulatory submissions
• Maintains and performs in leadership roles with external scientific groups, consortia, and committees to advance the science of modeling and simulation
• May supervise and/or mentor staff
Qualifications:
• PhD in Pharmacokinetics, Pharmacology, Systems Biology, Bio-Engineering, Mathematical Biology or a related area, with 5+ years of experience in the pharmaceutical industry
• Demonstrated technical expertise and strategic thinking on systems pharmacology, PBPK or pharmacometrics projects
• Demonstrated modeling expertise using state of the art software platforms, such as Matlab, R, NonMem, Simcyp, and/or GastroPlus
• Demonstrated ability to lead modeling and simulation projects to completion and driving impact while interfacing with multidisciplinary groups and regulatory agencies
• Excellent communication skills and ability to clearly convey strategies to leadership and cross functional partners
• Key leadership competencies: Leads cross-functional teams to enable collaborative performance; shows organizational vision in positioning the company for success; promotes effective collaboration across disciplines
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
About the company
AbbVie is an American publicly traded biopharmaceutical company founded in 2013.