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PK/PD modeling 관련 Job description
Senior Scientist, PKPD Modeling at ABL Bio in South Korea
Summary Description
This position participates as a member of the pharmacology team and is responsible for developing and executing PK-PD modeling and simulation (M&S) strategies in a collaborative environment with colleagues in preclinical and clinical pharmacology. This individual will apply state of the M&S methodologies to support the relationship PK and PD, FIH and middle stage clinical dose selection.
Key Responsibilities
- Develop/apply state of the art PK-PD modelling techniques to guide advancement of drug candidates across development phases (preclinical through early clinical development).
- Initiate and monitor outsourced M&S activities as required.
- Actively participate as PK/PD lead with project teams.
- Contribute to regulatory documents (e.g. IND) and attend meetings with regulators as required.
Experience & Education
- PhD, PharmD in Pharmaceutical sciences, Pharmacology, Toxicology or related discipline.
- At least 5 years of hands-on experience with development and application of M&S in a drug-development environment.
- Expertise in a specific therapeutic area and ability to demonstrate successful application of M&S tools in that area.
- Expert user of NONMEM, Phoenix-NLME, R/S-Plus or related software with requisite programming skills.
- Demonstrated skills in development of novel modeling approaches that incorporate factors such as receptor affinity, binding kinetics, and diurnal flux in response.
- Hands-on experience with PBPK model development and implementation is a plus.
- Hands-on experience with PK-PD modeling strategies to guide advancement of drug candidates from discovery through early clinical development is a plus.
- Excellent written/oral communication skills in English.
- Familiarity with regulatory guidance/expectations applicable to M&S.
