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Senior Director, Pharmacometrics

Simulations Plus, Inc.

Role overview

Qualifications

  • 12+ years of population PK and PK/PD professional modeling experience preferred
  • Proficiency in Monolix, NONMEM, and R
  • Professional experience in application of Pharmacometrics to Clinical Pharmacology preferred
  • Master’s degree in pharmacometrics, PK/PD, pharmaceutics, pharmacology, statistics, engineering, or related field

Responsibilities

  • Lead, manage, and collaborate effectively with cross-functional project teams to successfully support client requests
  • Serve as the main point of contact for assigned clients and projects
  • Build partnerships with clients to promote synergistic working relationships
  • Use state-of-the-art software to independently develop, evaluate and apply complex population PK, PK/PD and exposure-response models and simulations

Key facts

Hard skills

Population Model Mono Pharmacodynamics Drug Development Statistical Analysis Presentation Training

Other skills

  • Problem Solving
  • Mentorship
  • Communication
  • Critical Thinking
  • Social Skills

About the company

Simulations Plus, Inc. logo

Simulations Plus, Inc.

Digital Health & Health Tech

Simulations Plus is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI) and machine learning (ML), physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, and consumer goods companies, and regulatory agencies worldwide.For more information visit us at www.simulations-plus.com

Company details

Company typeSME
IndustryDigital Health & Health Tech
Company size51 - 200

Links

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Job description

Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. 

Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning, physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. 

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 bonus, and more! Check out how much our employees love working here: https://www.comparably.com/companies/simulations-plus.

The Senior Director, Pharmacometrics will lead cross-functional project teams through the successful completion of client goals. This role will engage in activities ranging from consultations on study design through the development and evaluation of models, the performance of simulations, and the presentation of results.

Department: Strategic Consulting Services/Clinical Pharmacology and Pharmacometrics

Internal Grade: 17

Direct Reports: Optional

Status: Exempt

Location: Remote 

Job Responsibilities: 

  • Lead, manage, and collaborate effectively with cross-functional project teams to successfully support client requests, providing strategic direction regarding the interpretation and integration of modeling and simulation results and findings
  • Serve as the main point of contact for assigned clients and projects, providing valuable insight regarding the optimal use of modeling and simulation in drug development programs, including study design considerations through the development and evaluation of models, and appropriate messaging to address critical questions 
  • Build partnerships with clients to promote synergistic working relationships
  • Use state-of-the-art software to independently develop, evaluate and apply complex population PK, PK/PD and exposure-response models and simulations
  • 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 
  • Write pharmacometric reports and regulatory documents 
  • Share scientific knowledge and skills with other staff members; mentor junior level scientists; may supervise assigned scientists 
  • Lead or contribute to the development of standard processes and methods. 
  • Teach workshops and develop new training material
  • Promote software and consulting service offerings; may assist in developing proposals and work scopes 
  • Serve as a role model for the advancement of consulting services
  • Other duties as assigned 

Qualifications: 

  • 12+ years of population PK and PK/PD professional modeling experience preferred 
  • Proficiency in Monolix, NONMEM, and R
  • 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 
  • Some travel required for meetings, trainings, and conferences 

Education: 

  • Master’s degree in pharmacometrics, PK/PD, pharmaceutics, pharmacology, statistics, engineering, or related field 
  • PhD in pharmacometrics, PK/PD, pharmaceutics, pharmacology, statistics, engineering, or related field preferred 

Find out more about how amazing it is to work at Simulations Plus by visiting www.simulations-plus.com/career-center and apply today!

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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