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

Simulations Plus• US,

2d•$190,000 - $220,000•Remote

About The Position

Simulations Plus is a leading provider in the biopharma sector, offering advanced software and consulting services for drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Their solutions integrate AI/ML, PBPK, PBPB, QSP/QXT, and population PK/PD modeling. They also provide simulation-enabled performance and intelligence solutions, along with medical communications support. Their technology is used by major pharmaceutical, biotechnology, and regulatory agencies globally. The company emphasizes a positive culture and employee well-being, offering remote work, flexible schedules, generous vacation, affordable health coverage, stock options, and annual bonuses.

Requirements

Proficiency in Monolix, NONMEM, and R
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

Nice To Haves

12+ years of population PK and PK/PD professional modeling experience preferred
Professional experience in application of Pharmacometrics to Clinical Pharmacology preferred

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.