Director, Translational Pharmacokinetics – DMPK

🔥 14 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $177k - $283.8k / year

⏰ Full Time

🔴 Lead

🌎 Translator / Interpreter

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Develop and validate physiologically based pharmacokinetic (PBPK) models to simulate drug absorption, distribution, metabolism, drug-drug interactions, and excretion (ADME/DDI) • Develop and evolve pharmacokinetic and pharmacodynamic (PKPD) models using nonclinical and clinical data • Support first-in-human (FIH) dose projections for drug candidates entering clinical development • Analyze nonclinical and clinical data and integrate diverse experimental data into models • Prepare simulation reports and evidence-based materials supporting regulatory decisions and submissions, including INDs, CTAs, IBs, briefing documents, regulatory responses, and health authority meeting materials • Participate in regulatory interactions and preparation activities • Collaborate with DMPK, clinical pharmacology, translation sciences, CMC, clinical development, regulatory affairs, and project management teams • Provide input into in vitro and in vivo study design for model development • Conduct DDI simulations and optimize dosing strategies under varied physiological conditions • Support candidate selection and transition programs from research into development • Evaluate emerging scientific and competitive landscape information • Present program recommendations to senior leadership and governance committees • Mentor junior scientists and contribute to organizational capabilities • Promote scientific rigor, innovation, and operational excellence across the portfolio

🎯 Requirements

• PhD, PharmD, or equivalent advanced scientific degree • 12+ years of industry experience in modeling and simulation of PBPK and PKPD models, and FIH dose projections • Demonstrated experience supporting IND-enabling programs and regulatory submissions • Solid understanding of the principles of ADME • Proficiency in pharmacokinetic modeling software including Simcyp, GastroPlus, Phoenix WinNonlin, and NONMEM • Ability to critically evaluate experimental data for input into models • Ability to thrive within a highly collaborative, matrixed biotechnology environment • Experience supporting CNS, neuroscience, rare disease, or sleep-wake disorder programs • Familiarity with FDA, EMA, and ICH regulatory requirements • Experience advancing programs from candidate selection through clinical development • Experience managing CRO networks and outsourced development activities • Strategic thinking and strong scientific judgment • Excellent communication and influencing skills • Cross-functional leadership • Strong project and risk management capabilities • Ability to balance scientific rigor with operational execution • Collaborative, hands-on leadership style • Adaptability and learning agility

🏖️ Benefits

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups and support networks