The Pharmacometrics Group applies a range of model informed drug development (MIDD) approaches to support early and late-stage development of small and large molecules. We are seeking a skilled and qualified industrial scientist who has experience in planning and executing MIDD approaches to join us as a Principal Scientist. In this role, you will be responsible for the recommendation and implementation of pharmacometrics methodologies, contributes to internal and external clinical pharmacokinetic (PK) and pharmacodynamics (PD) modeling and simulation activities. Conducts PK/PD modelling and simulation in support of early stage programs or internal decision-making of late-stage programs. Will present modelling and simulation analyses to internal project teams and may present to external colleagues or regulatory agencies. You will work with experienced pharmacometricians, Preclinical Pharmacokinetics, Drug Metabolism, Toxicology, and Clinical Pharmacology colleagues to provide inputs to overall product development plans and to address research and development objectives and issues
Your Contributions (include, but are not limited to):
- Represent the Pharmacometrics Group in multi-function matrix teams and serve as a subject matter expert
- Lead the planning, execution, and timely delivery of MIDD and Pharmacometrics strategies and documents to support dose selection, clinical trial design and regulatory submissions on assigned programs
- Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of regulatory submissions
- Independently conducts PK/PD analyses of data from Phase 1/2 studies and application of quantitative decision-making to assist in the characterization of population PK, dose- and exposure-response relationships to optimize subsequent clinical development
- Communicate and interpret modeling results to project teams. Accountable for ensuring appropriate design and implementation of pharmacometrics plans
- Collaborate with other colleagues to review and validate M&S outputs such as datasets and modeling programs
- Prepare posters, publications, presentations for internal and external conferences
- Performs other duties as assigned
Requirements:
- MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a specific focus on PK and PK/PD modeling and simulation and 10+ years of Pharmaceutical/Biotech industry experience in conduct and/or oversight of late-stage Modeling and Simulation activities, including conduct or oversight of small molecule population pharmacokinetic analyses. Experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects OR
- PharmD or PhD or equivalent preferred and 4+ years of relevant experience; may include postdoc experience
- Demonstrated foundation of scientific knowledge (e.g., basic pharmacokinetic/pharmacodynamic [PK/PD] and pharmacology concepts) and technical pharmacometrics skills including but not limited to nonlinear mixed effect modeling, mechanistic PK/PD, physiologically-based pharmacokinetic (PBPK), quantitative systems pharmacology (QSP) modeling and clinical trial simulations
- Competent in using modeling tools for population PK, PD analysis (e.g., NONMEM, Monolix, Simcyp, R packages for nonlinear mixed-effects modeling)
- Proactive, innovative, with good problem-solving skills
- Able to take different pharmacometrics assignments and deliver the results promptly
- Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to cross-functional audiences
- A critical thinker and quick learner with high engagement
- Demonstrated experience and track record in clinical-stage drug development is a plus
- Assimilates data and research findings outside of Company for application to new scientific projects
- Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
- May develop an understanding of other areas and related dependencies
- Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
- Ability to work as part of and lead multiple teams
- Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills
- Sees broader picture, impact on multiple programs, teams and/or departments
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management skills
- Ability to work in a cross functional team and matrix environment