PK/PD Modeler

Novartis Pharmaceuticals   •  

San Diego, CA

Industry: Healthcare

  •  

5 - 7 years

Posted 36 days ago

Job DescriptionNine! The number of disease areas that scientists at the Genomics Institute of the Novartis Research Foundation (GNF) are working in to discover and develop novel, innovative and transformative medicines. As part of the Drug Metabolism and Pharmacokinetics group, you will design and implement mechanistic PK/PD and quantitative systems pharmacology models in support of GNF’s pre-clinical portfolio. You will represent the PK/PD modeling and DMPK discipline on multi-disciplinary teams and integrate PK/PD and DMPK considerations into team strategy.

Your responsibilities include:
• Develop and apply quantitative models of complex systems such as tissue and cell dynamics and intracellular signaling, distribution and elimination kinetics in target cells, in silico modeling of compound cellular kinetics.
• Develop and implement quantitative mechanism-based PK/PD models which impact decisions regarding therapeutic modality selection, chemical optimization, translational strategies and early clinical trial design.
• Design and oversee experiments to define PK/PD relationships and competency using non-compartmental and compartmental techniques as well as pharmacokinetic modeling software.
• Represent the DMPK discipline on global cross-functional project teams while driving the design, execution, and analysis of DMPK and PK/PD. Design strategies and coordinate DMPK and PK/PD studies for preclinical projects in a variety of disease areas including oncology, immune-oncology, metabolic diseases and regenerative medicine.
• Collaborate with key stakeholders in pre-clinical development in support of the overall translational research strategy for projects. Enhance capabilities of group by implementing novel modeling approaches and technologies.

Minimum requirementsWhat you bring to the role:

• Knowledge and experience with the design of experiments to define PK/PD relationships and competency using semi-mechanistic and turnover models, non-compartmental and compartmental techniques and familiarity with pharmacokinetic modeling software (e.g. Adapt, Phoenix Winnonlin, Gastroplus or equivalent).

• Experience serving as DMPK and PK/PD representative on preclinical project teams; supporting drug discovery and preclinical development of small molecules, biotherapeutics and novel modalities.
• Expertise in utilizing DMPK resources across organizations to drive drug discovery efforts; collaboration with internal and external scientists to ensure aligned position on human PK/PD projections as drug candidates transition into the clinic.
• Innovative, driven, highly organized self-starter with the ability to handle multiple activities and interacting with collaborators in a multi-disciplinary, high-pace research environment. Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem solving.

Desirable Requirements:
• Minimum 5 years of pharmaceutical industry experience including preclinical PK/PD modeling, DMPK, drug development, protocol/IB preparation support.
• Ph.D. in pharmaceutical sciences, DMPK or related disciplines with thorough knowledge of PK/PD modeling and DMPK.

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