PBPK Modeler

AbbVie

Ludwigshafen, Germany

The Quantitative, Translational and ADME Sciences (QTAS) team at AbbVie, Inc. is seeking a scientist in the Germany who can perform a role as Physiologically-Based Pharmacokinetics (PBPK) modeler to provide small molecule project support across multiple therapeutic areas. The successful candidate will be responsible for conducting static and mechanistic PBPK, human PK, and drug-drug interactions (DDI) projections using in vitro and in vivo ADME/PK data to support Discovery and Development project teams, enabling compound progression from discovery to early stages of clinical development. The position will require close collaboration with lab functions within QTAS, Discovery project teams and other R&D stakeholders in order to develop and execute QTAS strategies necessary to select and facilitate the advancement of optimized candidate molecules. In this exciting and dynamic role you will also be expected to evaluate new technologies and approaches to support the mechanistic and translational understanding of drug disposition and drug-drug interactions. The ideal candidate will have strong background and hands-on experiences in PBPK modeling using a commercial software (e.g. Simcyp).

Responsibilities

Predict human PK and DDI profiles of small molecule drug candidates utilizing pre-clinical in vitro and in vivo ADME/PK data and static and mechanistic modeling tools;
Support project teams across multiple therapeutic areas and interpret results through close partnership with QTAS representatives;
Effectively communicate human PK/DDI prediction and PBPK modeling, QTAS strategy and knowledge to project teams, functional leaders, and other key stakeholders to ensure alignment and influence decisions;
Demonstrate thorough understanding of drug metabolism, pharmacokinetics and bioanalysis (DMPK-BA) necessary for the characterization of small molecule drug candidates to support regulatory submissions;
Stay current with latest developments in the field of human PK and DDI predictions including empirical (e.g. allomeric scaling) and more mechanistic models (e.g. PBPK).

Qualifications

Doctorate (Ph.D.) in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, Biomedical Engineering or related field with at least 2 years of experience in the pharmaceutical or biotechnology industries;
Experience with relevant modeling software, including Simcyp and Phoenix WinNonlin is required;
Hands-on project experience in PBPK modeling and simulation through direct industry experience as well as knowledge of regulatory expectations regarding PBPK modeling is preferred;
Experience in the field of DMPK with a general understanding of one or more disciplines within DMPK and knowledgeable in one or more of the following areas: in vitro ADME, pharmacokinetics, transporter, DDI, translational modeling, biotransformation, biomarker strategy;
Demonstrated publication record; lead/senior author contributions a plus;
Ability to influence, negotiate and communicate effectively with both internal and external stakeholders; ability to work well in a collaborative fast-paced team environment;
Highly motivated, self-driven and results-oriented with excellent communication and presentation skills; capable of working both as team player and project driver;
High degree of flexibility in adapting to different projects and people; excellent networking and relationship-building (both internal and external) skills;
Passion for data analysis, solving technical problems and applying new technologies to further scientific goals.

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 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.

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