Director, Pharmacometrics (Pop PK and PK/PD)

Simulations Plus; United States; Remote; USD 180,000 - 210,000; Full time

Benefits offered by this job

Remote work

Flexible schedules

Generous vacation policy

Affordable health coverage

Annual bonus

Job summary

Simulations Plus is seeking a Director, Pharmacometrics (Pop PK and PK/PD) to lead cross-functional teams in a fully remote capacity. This role focuses on developing and evaluating complex models, conducting simulations, and presenting results to clients to support drug development programs.

The ideal candidate has 10+ years of population PK/PK/PD modeling experience, and is proficient with Monolix, NONMEM, and R.

Qualifications

• 10+ years of population PK and PK/PD modeling experience preferred.
• Proficient at developing and delivering presentations.
• Professional experience applying Pharmacometrics to Clinical Pharmacology.
• Willing to travel for meetings, trainings, and conferences.

Responsibilities

• Independently develop and evaluate complex models and simulations.
• Lead cross-functional project teams to support client requests.
• Build partnerships with clients and provide strategic input.
• Provide direction on integrating modeling results for drug development.
• Write pharmacometric reports and regulatory documents.
• Mentor junior scientists and possibly supervise staff.
• Promote software and consulting offerings and assist in proposals.
• Communicate modeling results clearly to clients.

Skills

Population PK modeling

PK/PD modeling

Monolix

NONMEM

R

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

Tools

Monolix

NONMEM

R

Job description

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Director, Pharmacometrics (Pop PK and PK/PD)

Full Time Professional US 1 Attachments

4 days ago Requisition ID: 1086

Salary Range: $180,000.00 To $210,000.00 Annually

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
• 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