Director, Pharmacometrics

Simulations Plus is a leading developer of modeling and simulation software, and a provider of consulting services. We support our pharmaceutical and biotechnology clients through drug discovery, development research, and regulatory submissions.

Leadership truly cares about maintaining a positive culture and employee well-being. We offer fully remote work, flexible schedules, unlimited vacation along with free medical premiums, stock options, bonus potential, and more! 

The Director, Pharmacometrics will lead multi-disciplinary 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. 

Business Unit: Clinical Pharmacology and Pharmacometrics (CPP)

Department: Scientific

Location: This position can be 100% remote or hybrid near one of our locations (Buffalo, NY; Durham, NC; Lancaster, CA; Paris, FR; or Pittsburgh, PA)

Job Responsibilities: 

• Independently develop and evaluate complex models and simulations
• Lead, manage, and work with multidisciplinary 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, 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
• Collaborate effectively in cross-functional teams to deliver analysis results
• 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
• Population PK and PK/PD modeling experience
• Professional experience in applying Pharmacometrics preferred  
• Great at developing and delivering presentations
• Highly self-motivated and willing to take on challenges
• Possess excellent critical-thinking and problem-solving skills
• Strong verbal and written communication 
• Work effectively with a wide range of constituencies in a diverse community
• Some travel required for meetings, trainings, and conferences

 Education: 

• Masters in pharmacometrics, PK/PD, pharmaceutics, pharmacology, engineering, or related field 
• PhD in pharmacometrics, PK/PD, pharmaceutics, pharmacology, 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!