Director, Pharmacometrics (Pop PK and PK/PD)

Simulations Plus• US,

2d•$180,000 - $210,000•Remote

About The Position

Simulations Plus is a leading provider in the biopharma sector, offering advanced software and consulting services that support various stages of drug development, from discovery to commercialization. Our solutions integrate AI/ML, PBPK, PBPB, QSP/QXT, and population PK/PD modeling. We also provide simulation-enabled performance and intelligence solutions, along with medical communications support. Our technology is used globally by major pharmaceutical companies, biotech firms, and regulatory agencies. We foster a positive culture with a focus on employee well-being, offering fully remote work, flexible schedules, a generous vacation policy, affordable health coverage, and an annual bonus.

Requirements

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

Responsibilities

Lead cross-functional project teams through the successful completion of client goals.
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.
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.