GlaxoSmithKline
Manager/Associate Director, CPMS Oncology
GlaxoSmithKline, Baltimore, Maryland, United States
Overview
GSK has an inspiring ambition: by uniting science, technology and talent, we aim to positively impact the health of 2.5 billion people over the next ten years. We focus on the science of the immune system, human genetics and advanced technologies, including functional genomics and AI/ML. We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join the Oncology Clinical Pharmacology Modeling and Simulation (CPMS) group within the Oncology Translational Medicine department. CPMS supports scientists who learn, contribute and influence business decisions through innovation and expertise. As Manager or Associate Director, CPMS, you will be part of a science-driven group delivering clinical pharmacology and modeling and simulation excellence to research and development programs. You will work on small molecules, biologics, antibody-drug conjugates and other modalities in Oncology. CPMS responsibilities span from approximately 6 months prior to FTIH through submission and lifecycle management.
Key Responsibilities
Planning, conducting and reporting population pharmacokinetic modeling, exposure–response analysis, simulation-based trial design and dose selection, and drug–disease modeling Applying innovative methods such as longitudinal exposure–response analysis, model-based meta-analysis and quantitative systems pharmacology to enhance data use and trial efficiency Presenting strategy and defending outcomes of model-based approaches to internal governance boards and regulatory agencies Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions Write or review clinical pharmacology components of regulatory documents and responses to ensure rapid and efficient approvals with optimal labeling Implement best practices, trends and lessons learned to advance clinical pharmacology modeling and simulation contributions to the R&D pipeline Interact with line and middle management, staff and external contacts on functional, strategic and tactical levels Promote model-informed drug discovery and development through external collaboration, journal publication and conference presentation Why you?
Basic Qualifications: A doctorate (PharmD, PhD, MD) or master’s degree in quantitative clinical pharmacology and pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) 2 or more years of experience in population PK, exposure–response, mechanistic PKPD and/or longitudinal disease modeling with proficiency in NONMEM, Monolix, or R 2 or more years of experience in the design, analysis, interpretation and reporting of clinical pharmacology studies per industry and regulatory standards for associate director level Preferred Qualifications: Demonstrated collaboration in a multi-discipline team with effective communication and accountability for timely results Prior experience in Oncology Research and Development is a plus Prior experience in leveraging AI/ML for pharmacometrics and/or MID3 Strong drive and learning agility to build knowledge on drug–disease systems, symptom progression, standard of care, and trial design Knowledge of or ability to quickly learn cancer mechanisms, endpoints, progression and treatments Ability to use sound judgment in complex situations and adapt to changing business needs by prioritizing tasks Passion for quantitative clinical pharmacology and a desire to innovate for better outcomes Track record of implementing MID3 approaches to accelerate patient access and expand indications Experience working with senior stakeholders in a cross-functional environment
Work Locations
USA - Pennsylvania - Upper Providence; USA - Massachusetts – Waltham; USA - North Carolina - Durham GSK is an Equal Opportunity Employer. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK does not accept referrals from employment businesses or agencies without prior authorization. This notice ensures compliance with procurement and human resources processes.
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GSK has an inspiring ambition: by uniting science, technology and talent, we aim to positively impact the health of 2.5 billion people over the next ten years. We focus on the science of the immune system, human genetics and advanced technologies, including functional genomics and AI/ML. We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join the Oncology Clinical Pharmacology Modeling and Simulation (CPMS) group within the Oncology Translational Medicine department. CPMS supports scientists who learn, contribute and influence business decisions through innovation and expertise. As Manager or Associate Director, CPMS, you will be part of a science-driven group delivering clinical pharmacology and modeling and simulation excellence to research and development programs. You will work on small molecules, biologics, antibody-drug conjugates and other modalities in Oncology. CPMS responsibilities span from approximately 6 months prior to FTIH through submission and lifecycle management.
Key Responsibilities
Planning, conducting and reporting population pharmacokinetic modeling, exposure–response analysis, simulation-based trial design and dose selection, and drug–disease modeling Applying innovative methods such as longitudinal exposure–response analysis, model-based meta-analysis and quantitative systems pharmacology to enhance data use and trial efficiency Presenting strategy and defending outcomes of model-based approaches to internal governance boards and regulatory agencies Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions Write or review clinical pharmacology components of regulatory documents and responses to ensure rapid and efficient approvals with optimal labeling Implement best practices, trends and lessons learned to advance clinical pharmacology modeling and simulation contributions to the R&D pipeline Interact with line and middle management, staff and external contacts on functional, strategic and tactical levels Promote model-informed drug discovery and development through external collaboration, journal publication and conference presentation Why you?
Basic Qualifications: A doctorate (PharmD, PhD, MD) or master’s degree in quantitative clinical pharmacology and pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) 2 or more years of experience in population PK, exposure–response, mechanistic PKPD and/or longitudinal disease modeling with proficiency in NONMEM, Monolix, or R 2 or more years of experience in the design, analysis, interpretation and reporting of clinical pharmacology studies per industry and regulatory standards for associate director level Preferred Qualifications: Demonstrated collaboration in a multi-discipline team with effective communication and accountability for timely results Prior experience in Oncology Research and Development is a plus Prior experience in leveraging AI/ML for pharmacometrics and/or MID3 Strong drive and learning agility to build knowledge on drug–disease systems, symptom progression, standard of care, and trial design Knowledge of or ability to quickly learn cancer mechanisms, endpoints, progression and treatments Ability to use sound judgment in complex situations and adapt to changing business needs by prioritizing tasks Passion for quantitative clinical pharmacology and a desire to innovate for better outcomes Track record of implementing MID3 approaches to accelerate patient access and expand indications Experience working with senior stakeholders in a cross-functional environment
Work Locations
USA - Pennsylvania - Upper Providence; USA - Massachusetts – Waltham; USA - North Carolina - Durham GSK is an Equal Opportunity Employer. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK does not accept referrals from employment businesses or agencies without prior authorization. This notice ensures compliance with procurement and human resources processes.
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