Senior Pharmacokineticist at CSL Limited in King Of Prussia, PA
Reporting into the Director, Pharmacokinetics & Quantitative Systems Pharmacology, your main responsibilities include:
Serve as the lead PKPD project scientist for a variety of programs and drug modalities; biologics and novel platforms such as cell- and gene-therapy, gene-editing, and non-viral gene delivery. Provide scientific expertise and guidance in biologics research and development related activities and is willing to evolve knowledge into novel areas of interest, such as gene therapy. Serve as technical expert for the PK/QSP organization in the application of advanced PK/PD, mechanistic, and disease modeling principles and methodologies. Perform advanced PK/PD modeling utilizing mechanistic and semi-mechanistic approaches to define the dose-concentration-efficacy/toxicity relationships, formulate various study design scenarios, and outcome prediction, to inform decision making. Lead study design discussions, study protocols development, including sample size calculations, data analysis plan, and report population PK and PK/PD analysis results to management and review committees. Actively maintain relationships and collaborate with colleagues within the Pharmacology/Toxicology organization and CSL Behring at large. Establish and maintain external collaborations with academic groups active in a variety of ADME/PKPD areas of research worldwide. Setup contracts and interface with external vendors per business requirements. Required Qualifications A PhD in Pharmaceutical Sciences or related subject area with six years of pharmaceutical development experience in pharma, biotech, or CRO, with a focus on modeling and simulation or a Master's degree in Pharmaceutical Sciences or related subject area with 8 years of relevant experience. Thorough knowledge of pharmacokinetics, PK/PD modeling principles, as well as basic statistics. Hands-on experiences with population approach in describing PK/PD data, using industry standard software packages, such as Phoneix WinNonLin, NONMEM, R, etc. Demonstrated experience in planning, overseeing, evaluating, and reporting PK/PD studies. Experience reviewing and applying statistical analyses to inform preclinical study design; sample size. etc. is highly desirable Demonstrated experience supporting biologics research and development projects in collaboration with internal or external experts. Excellent communication and interpersonal skills is required
Salary Range:
$200K -- $250K
Minimum Qualification
Pharmacy, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Serve as the lead PKPD project scientist for a variety of programs and drug modalities; biologics and novel platforms such as cell- and gene-therapy, gene-editing, and non-viral gene delivery. Provide scientific expertise and guidance in biologics research and development related activities and is willing to evolve knowledge into novel areas of interest, such as gene therapy. Serve as technical expert for the PK/QSP organization in the application of advanced PK/PD, mechanistic, and disease modeling principles and methodologies. Perform advanced PK/PD modeling utilizing mechanistic and semi-mechanistic approaches to define the dose-concentration-efficacy/toxicity relationships, formulate various study design scenarios, and outcome prediction, to inform decision making. Lead study design discussions, study protocols development, including sample size calculations, data analysis plan, and report population PK and PK/PD analysis results to management and review committees. Actively maintain relationships and collaborate with colleagues within the Pharmacology/Toxicology organization and CSL Behring at large. Establish and maintain external collaborations with academic groups active in a variety of ADME/PKPD areas of research worldwide. Setup contracts and interface with external vendors per business requirements. Required Qualifications A PhD in Pharmaceutical Sciences or related subject area with six years of pharmaceutical development experience in pharma, biotech, or CRO, with a focus on modeling and simulation or a Master's degree in Pharmaceutical Sciences or related subject area with 8 years of relevant experience. Thorough knowledge of pharmacokinetics, PK/PD modeling principles, as well as basic statistics. Hands-on experiences with population approach in describing PK/PD data, using industry standard software packages, such as Phoneix WinNonLin, NONMEM, R, etc. Demonstrated experience in planning, overseeing, evaluating, and reporting PK/PD studies. Experience reviewing and applying statistical analyses to inform preclinical study design; sample size. etc. is highly desirable Demonstrated experience supporting biologics research and development projects in collaboration with internal or external experts. Excellent communication and interpersonal skills is required
Salary Range:
$200K -- $250K
Minimum Qualification
Pharmacy, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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