Director, Translational Pharmacokinetics – DMPK

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $177k - $283.8k / year

⏰ Full Time

🔴 Lead

🌎 Translator / Interpreter

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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 global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 Description

• Design and implement PBPK models representing drug behavior in biological systems • Create and evolve PKPD models using nonclinical and clinical data • Support first-in-human dose projections for selected drug candidates • Integrate pharmacokinetic and pharmacodynamic experimental data to improve model accuracy • Provide evidence-based simulations for 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 • Conduct simulations to predict drug-drug interactions • Optimize dosing strategies under varying 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 build 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 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 • 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 partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities

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