We are seeking a passionate scientist to serve as a DMPK representative in an integrated project team to develop cutting edge biotherapeutics with a focus on cell and gene therapies.
As a project team member, he/she will be responsible for i) developing and implementing PK and PK/PD plans as part of the discovery or development team strategy, ii) enabling PK/PD/efficacy/safety studies, iii) coordinating all DMPK-related assays, iv) initiating and engaging in multifunctional collaborations to facilitate the optimization of drug candidates, and v) preparing DMPK-related IND/BLA documents to support regulatory submissions. From a scientific aspect, this role will be responsible for analyzing and reporting pharmacokinetic (cellular kinetic data for cell therapy) data, conducting quantitative PK/PD data integration and translational analysis to enable candidate selection and First-In-Human human dose and dosing regimen projection. The scientist will contribute to project team strategies from early discovery phase to clinical development.
Applicants must have a Ph.D. degree, or a master’s degree with 6+ years of experience, or a bachelor’s degree with 8+ years of experience in pharmacokinetics, systems biology, or related fields. Applicants with post-doctoral training or industry working experience in CAR T, gene therapies, or PBPK and PK/PD modeling are preferable.
For applicants with academic background in pharmacokinetics, solid PK and ADME knowledge, strong quantitative PK/PD analysis, and modeling skills are required. Applicants must be familiar with modeling software, such as WinNonlin, ADAPT, NONMEM, MATLAB, and SAMII. In addition, applicants should demonstrate strong interests and learning capability to become an expert in the area of immunology, cancer biology, and gene therapy.
For applicants with academic background in systems biology, extensive expertise in mathematical modeling of biological system is required. Experience with analyzing genomic, transcriptomic, or proteomic data is highly desirable. Applicants should also demonstrate strong interests in and capability of learning new therapeutic modalities and the associated biology.
Strong writing and verbal communication skills and the ability to work in a matrix and global environment are essential.