Associate Director, Quantitative Clinical Pharmacology

🔥 48 minutes ago

🇺🇸 United States – Remote

💵 $120k - $165k / year

⏰ Full Time

🟠 Senior

👔 Director

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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 multi-disciplinary project teams through successful completion of client goals • Lead and collaborate on quantitative clinical pharmacology projects and programs • Provide clinical pharmacology and pharmacometric consultation to company projects and programs • Support clinical study protocols, study conduct, data analysis, and report writing • Participate in regulatory interactions with health authorities • Provide consulting using PBPK, population PK, PK/PD, exposure-response modeling and simulation, and noncompartmental analyses • Use GastroPlus, MONOLIXSuite, NONMEM, R, and other tools • Ensure appropriateness of methods, data integrity, and accuracy of results • Maintain communication between the company and clients throughout project execution • Engage clients on strategic approach, results presentation, regulatory implications, and findings • Initiate and maintain client relationships • Prepare technical reports, synopses, executive summaries, and regulatory documents • Conduct advanced literature searches and integrate research findings into project methodology and results • Share findings with internal and external project teams • Prepare abstracts, presentations, and publication-ready manuscripts • Mentor and provide feedback to junior scientists • Participate in cross-divisional scientific strategy discussions • Serve as an expert resource for the Business Development Team • Provide guidance on drug development and regulatory approval challenges • Stay current with relevant literature • Develop and teach workshops and courses • Perform other duties as assigned

🎯 Requirements

• 6+ years of applied clinical pharmacology experience preferred • 4+ years of leading projects, programs, and scientists preferred • Previous supervision of junior clinical pharmacologists and pharmacometricians, fellows, and students preferred • Strong experience presenting scientific results to professional audiences • Extensive experience preparing, submitting, and receiving approval for publications in scientific journals • Population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling and simulation experience • Non-compartmental and compartmental pharmacokinetics experience • Mechanistic physiologically based pharmacokinetic modeling and simulation experience • Excellent communication, presentation, and leadership skills • Relationship-building skills with the ability to work closely with project leaders and team members • Strong organization skills and ability to handle multiple tasks simultaneously • Ability to handle tight deadlines • Critical-thinking and problem-solving skills • Some travel required for meetings, conferences and events • PharmD, PhD, or masters in pharmacokinetics, clinical pharmacology, or related field • Advanced clinical pharmacology related training preferred

🏖️ Benefits

• Fully remote work • Flexible schedules • Generous vacation policy • Affordable health coverage • Annual bonus • Positive culture and employee well-being • Attendance and presentation at international, national, and regional scientific conferences, client meetings, and government meetings • Development and teaching opportunities through GastroPlus, MONOLIX, and other workshops and courses

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