Tbwa Chiat/Day Inc
Associate Director/Director of Pharmacometrics
Tbwa Chiat/Day Inc, Waltham, Massachusetts, United States, 02254
Associate Director/Director of Pharmacometrics
Waltham, Massachusetts, United StatesAssociate Director/Director of PharmacometricsDragonfly Therapeutics seeks an experienced and highly motivated individual to join our Clinical Pharmacology team. Reporting directly to the Head of Clinical Pharmacology, this individual will provide leadership and technical expertise to support drug development and develop the right drug, at the right dose, for the right patient using model-informed drug research and development.We are looking for a candidate who thrives in a fast-paced environment that rewards curiosity, adaptability, and boldness. The successful candidate will leverage their scientific expertise and a thorough understanding of drug development to generate and analyze PK-PD data, implement PK-PD modeling & simulation to select FIH dose levels for our drug development programs.Responsibilities (including but not limited to):Accountable and responsible for non-compartmental analysis of PK data and ensuring appropriate PK-PD data are generated and analyzed including population PK, PK-PD modeling and simulation, meta-analysis etc., to support drug development.Contribute to the analysis of in-vitro and pre-clinical PK/PD data for selection of first in humans (FIH) dose levels as well as human efficacious dose projection.Participate in implementing Model Based Drug Development using quantitative approaches to address complex questions arising during drug development, and integrate PK-PD knowledge on an ongoing project basis.Create analysis datasets by integrating data from diverse sources for pharmacometric analyses with strong attention to quality and detail.Apply solid knowledge of pharmacokinetics, pharmacodynamics, and other scientific areas in partnership with other functional groups to identify opportunities to apply modeling & simulation and/or QSP approaches to quickly advance drug development programs.Support the preparation and delivery of relevant sections in IND, IB, clinical study protocols, analysis plans, data analyses, data interpretation, and study reports.Qualifications:Doctorate degree (PhD or PharmD) with 8+ years of relevant experience, or Master’s degree with 12+ years of relevant experience, or Bachelor's degree with 17+ years of relevant experience (title commensurate with experience; biotech experience strongly preferred).Hands-on experience in pharmacokinetics, pharmacometrics, clinical pharmacology, population PK and exposure-response modeling & simulation.Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands-on experience using modeling and simulation software (e.g., NONMEM, R, Phoenix WinNonlin, Phoenix NLME, PsN, etc.).Experience in preparing data sets for pharmacometric analysis in NONMEM, NLME, or WinNonLin, detecting data anomalies, and resolving data issues in collaboration with other functions.Working knowledge about CDISC requirement and SDTM/ADaM dataset structure.Knowledge of Clinical Pharmacology and the application of Modeling & Simulation.Able to understand clinical effects, pharmacological, physiological, and biochemical understanding.Knowledge of basic pharmacology in vivo/in vitro models.Able to understand/interpret safety/pharmacology/toxicology data.Excellent interpersonal and communication skills.About Dragonfly:Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
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Waltham, Massachusetts, United StatesAssociate Director/Director of PharmacometricsDragonfly Therapeutics seeks an experienced and highly motivated individual to join our Clinical Pharmacology team. Reporting directly to the Head of Clinical Pharmacology, this individual will provide leadership and technical expertise to support drug development and develop the right drug, at the right dose, for the right patient using model-informed drug research and development.We are looking for a candidate who thrives in a fast-paced environment that rewards curiosity, adaptability, and boldness. The successful candidate will leverage their scientific expertise and a thorough understanding of drug development to generate and analyze PK-PD data, implement PK-PD modeling & simulation to select FIH dose levels for our drug development programs.Responsibilities (including but not limited to):Accountable and responsible for non-compartmental analysis of PK data and ensuring appropriate PK-PD data are generated and analyzed including population PK, PK-PD modeling and simulation, meta-analysis etc., to support drug development.Contribute to the analysis of in-vitro and pre-clinical PK/PD data for selection of first in humans (FIH) dose levels as well as human efficacious dose projection.Participate in implementing Model Based Drug Development using quantitative approaches to address complex questions arising during drug development, and integrate PK-PD knowledge on an ongoing project basis.Create analysis datasets by integrating data from diverse sources for pharmacometric analyses with strong attention to quality and detail.Apply solid knowledge of pharmacokinetics, pharmacodynamics, and other scientific areas in partnership with other functional groups to identify opportunities to apply modeling & simulation and/or QSP approaches to quickly advance drug development programs.Support the preparation and delivery of relevant sections in IND, IB, clinical study protocols, analysis plans, data analyses, data interpretation, and study reports.Qualifications:Doctorate degree (PhD or PharmD) with 8+ years of relevant experience, or Master’s degree with 12+ years of relevant experience, or Bachelor's degree with 17+ years of relevant experience (title commensurate with experience; biotech experience strongly preferred).Hands-on experience in pharmacokinetics, pharmacometrics, clinical pharmacology, population PK and exposure-response modeling & simulation.Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands-on experience using modeling and simulation software (e.g., NONMEM, R, Phoenix WinNonlin, Phoenix NLME, PsN, etc.).Experience in preparing data sets for pharmacometric analysis in NONMEM, NLME, or WinNonLin, detecting data anomalies, and resolving data issues in collaboration with other functions.Working knowledge about CDISC requirement and SDTM/ADaM dataset structure.Knowledge of Clinical Pharmacology and the application of Modeling & Simulation.Able to understand clinical effects, pharmacological, physiological, and biochemical understanding.Knowledge of basic pharmacology in vivo/in vitro models.Able to understand/interpret safety/pharmacology/toxicology data.Excellent interpersonal and communication skills.About Dragonfly:Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.Our mission is to revolutionize disease treatment by inventing natural killer cell-based therapies for vastly improved patient outcomes. We believe in a small team with a big impact.
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