About The Position

Simulations Plus is a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry. Our biosimulation solutions integrate artificial intelligence/machine learning, physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. Leadership truly cares about maintaining a positive culture and employee well-being. We offer fully remote work, flexible schedules, and generous vacation policy along with affordable health coverage, stock options, annual bonuses, and more!

Requirements

  • Proficiency in Monolix, NONMEM, and R
  • 5-7 years of population PK and PK/PD professional modeling experience preferred
  • Professional experience in application of Pharmacometrics to Clinical Pharmacology preferred
  • Proficient at developing and delivering presentations
  • Highly self-motivated and willing to take on challenges
  • Possess excellent critical-thinking, problem-solving, and interpersonal skills
  • Strong verbal and written communication

Nice To Haves

  • Some travel required for meetings, trainings, and conferences

Responsibilities

  • Independently develop and evaluate complex models and simulations
  • Lead, manage, and collaborate effectively with cross-functional project teams to successfully support client requests
  • Build partnerships with clients; provide strategic input and advice
  • Serve as main point of contact for assigned clients and projects
  • Consult with clients on study design through development and evaluation of models
  • Provide valuable insight into the optimal use of modeling and simulation in drug development programs
  • Clearly communicate and present modeling and simulation results to clients
  • Use state-of-the-art software to develop, evaluate and apply PK, PK/PD and exposure-response models
  • Formulate pharmacometric data analysis plans and data requirement documents, ensuring appropriateness of methods for data handling and analysis and compliance with current global regulatory guidance
  • Perform model-based simulations to address critical development questions
  • Write pharmacometric reports and regulatory documents
  • Utilize internal resources to meet project timelines and budgets
  • Share scientific knowledge and skills with other staff members
  • Other duties as assigned

Benefits

  • Fully remote work
  • Flexible schedules
  • Generous vacation policy
  • Affordable health coverage
  • Stock options
  • Annual bonuses
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