Senior Director, Pharmacometrics – Pop PK, PK/PD

🔥 7 minutes ago

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Simulations Plus, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1996

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

💰 Grant - Simulations Plus on 2024-11

Pharmaceuticals • Biotechnology • SaaS

Simulations Plus, Inc. is a science-driven software and consulting company that provides mechanistic modeling, AI-enabled workflows, and expert services to support model‑informed drug development (MIDD) across discovery, development, clinical operations, and commercialization. Its product suite includes GastroPlus (PBPK/PBBM), MonolixSuite (pharmacometrics), ADMET Predictor (ML for ADMET), DILIsym (quantitative systems toxicology), Thales (QSP), and Pro‑ficiency (learning/simulation), and the company offers consulting, training, regulatory strategy support, and bundled solution packages. Simulations Plus emphasizes mechanistic and AI-enabled tools for ADMET prediction, PBPK, pharmacometrics, QSP/QST and serves pharmaceutical and biotech clients (noting ~30+ years in business, ~280+ clients and use by 19 of the top 20 pharma companies).

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• Fully remote work • Flexible schedules • Generous vacation policy • Affordable health coverage • Stock options • Annual bonus • More!