The ideal candidate will have strong background and expertise in PBPK modeling and have made significant contributions to this scientific field.
Key Responsibilities: Build and deliver a robust translational strategy for human PK and DDI projection Utilize PBPK and translational modeling tools to enable human PK and DDI projections.
Support project teams across multiple therapeutic areas and interpret results through close partnership with DMPK-BA reps.
Evaluate and guide novel in vitro tools and methodology to improve translational predictions Liaise with key stakeholders (in discovery (chemistry/biology/pharmacology) and development (pharmaceutics, clinical pharmacology) to generate data and knowledge supporting the build-up of translational, mechanistic models.
Communicate effectively and clearly both internally and externally on DMPK-BA strategies and ensure strategic use of pre-clinical in vitro and PK studies, human PK/DDI prediction and PBPK modeling to deliver state-of the-art PBPK models Write, review, and contribute to regulatory submission documents.
Stay current with latest developments in the field of DMPK PBPK modeling Contribute to the scientific community internally (e.g.
education sessions) and externally (e.g.
publication) to maintain a strong influencing presence in the field of translational modeling.
Qualifications Qualifications: Ph.D.
in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, Biomedical Engineering or related field and 8-10 years of relevant experience in the pharmaceutical industry Experience with relevant modeling software, including SimCYP, Phoenix and WinNonlin is required Hands-on project experience in PBPK modeling and simulation through direct industry experience required Highly motivated, result-oriented person and independent thinker with proven ability to work cross-functionally and influence peers and other stakeholders Demonstrated capability to mentor junior scientists and manage in a matrix environment Comprehensive understanding of pre-clinical PK, PBPK Passion for data analysis, solving technical problems and applying new technologies to further scientific goals Knowledge of regulatory expectations regarding PBPK modeling is desired Proven ability to work in a team environment; ability to work well in a collaborative fast-paced team environment Excellent oral and written communication skills and the ability to influence Thorough theoretical and practical understanding of own scientific discipline 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.
Level and compensation will be commensurate with experience.