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!
