Senior Director, Pharmacometrics – Pop PK, PK/PD

🕒 Julho 30

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Simulations Plus, Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 1996

💊 Farmacêutico

🧬 Biotecnologia

☁️ SaaS

💰 Grant - Simulations Plus em 2024-11

Pharmaceuticals • Biotechnology • SaaS

A Simulations Plus, Inc. é uma empresa de software e consultoria orientada pela ciência que fornece modelagem mecanicista, fluxos de trabalho habilitados por IA e serviços especializados para apoiar o desenvolvimento de medicamentos informado por modelos (MIDD) em todas as etapas de descoberta, desenvolvimento, operações clínicas e comercialização. Seu conjunto de produtos inclui o GastroPlus (PBPK/PBBM), MonolixSuite (farmacometria), ADMET Predictor (ML para ADMET), DILIsym (toxicologia de sistemas quantitativos), Thales (QSP) e Pro‑ficiency (aprendizado/simulação), e a empresa oferece consultoria, treinamento, apoio em estratégia regulatória e pacotes de soluções integrados. A Simulations Plus enfatiza ferramentas mecanicistas e habilitadas por IA para predição ADMET, PBPK, farmacometria, QSP/QST e atende clientes das indústrias farmacêutica e biotecnológica (destacando ~30+ anos de mercado, ~280+ clientes e uso por 19 das 20 maiores empresas farmacêuticas).

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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