Associate Director, Pharmacometrics (Pop PK and PK/PD)

Simulations Plus, Inc.; United States; Remote; USD 150,000 - 210,000; Full time

Benefits offered by this job

Fully remote work

Flexible schedules

Generous vacation policy

Affordable health coverage

Annual bonus

Job summary

Simulations Plus, Inc. is seeking an Associate Director, Pharmacometrics to lead cross-functional project teams through study design, model development, simulations and results presentation.

The role involves engagement with Clinical Pharmacology and Pharmacometrics activities, collaborating with clients and internal staff to deliver model-based solutions remotely. The successful candidate will bring extensive PK/PD modeling experience, proficiency in Monolix/NONMEM/R, and strong communication

Qualifications

• 6+ years of population PK and PK/PD modeling experience.
• Experience applying pharmacometrics to Clinical Pharmacology.
• Strong presentation and communication skills; able to lead cross-functional teams.

Responsibilities

• Independently develop and evaluate complex models and simulations.
• Lead, manage, and collaborate with cross-functional project teams to 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 insights into modeling and simulation in drug development programs.
• Communicate and present modeling results to clients clearly.
• Use state-of-the-art software to develop PK/PD/exposure-response models.
• Formulate data analysis plans and ensure data handling compliance.
• Perform model-based simulations to address development questions.
• Write pharmacometric reports and regulatory documents.
• Utilize internal resources to meet timelines and budgets.
• Share scientific knowledge with staff.

Skills

Monolix

NONMEM

R

PK/PD modeling

Presentation skills

Communication

Travel flexibility

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

Job description

Simulations Plus stands as a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions.

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 Associate 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: 14

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
• 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

• Proficiency in Monolix, NONMEM, and R
• 6+ 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
• 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