Director, Pharmacometrics (Pop PK and PK/PD)

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

The 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: 16
• Direct Reports: No
• Status: Exempt
• Location: Remote

Job 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
• Provide strategic direction regarding the integration of modeling and simulation results and findings
• Assist in teaching workshops and providing training
• Mentor junior level scientists; may supervise assigned scientists
• Promote software and consulting service offerings; may assist in developing proposals and work scopes
• 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

Qualifications:

• 10+ years of population PK and PK/PD modeling experience preferred
• Proficiency in Monolix, NONMEM, and R
• Professional experience in application of Pharmacometrics to Clinical Pharmacology 
• 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!