Director, Translational Pharmacokinetics – DMPK

Eli Lilly and Company

. Develop and validate physiologically based pharmacokinetic (PBPK) models to simulate drug absorption, distribution, metabolism, drug-drug interactions, and excretion (ADME/DDI) .

Posted 10/20/2026full-timeRemote • Massachusetts • United StatesLead💰 $177,000 - $283,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in developing and validating PBPK and PKPD models, with a strong focus on regulatory submissions and collaboration across multidisciplinary teams. Proven ability to analyze complex data and provide strategic insights for drug development and candidate selection.

Highest-signal resume keywords

Pharmacokinetic ModelingPBPK Model DevelopmentRegulatory Submissions SupportCollaboration in BiotechnologyProject and Risk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmacokinetic Modeling SoftwareSimcypGastroPlusPhoenix WinNonlinNONMEMADME PrinciplesData AnalysisDose ProjectionsModel ValidationCNS Program Support

Soft Skills

Excellent CommunicationInfluencing SkillsStrategic ThinkingCollaborative LeadershipAdaptability

Certifications & Qualifications

PhDPharmD

Industry Keywords

IND-Enabling ProgramsFDA Regulatory RequirementsEMA Regulatory RequirementsICH GuidelinesClinical Development

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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