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Director, Translational Pharmacokinetics – DMPK
Eli Lilly and Company. Design and implement PBPK models representing drug behavior in biological systems .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in designing and implementing PBPK and PKPD models, with a strong focus on regulatory submissions and dose projections. Proven ability to collaborate across multidisciplinary teams while mentoring junior scientists and promoting scientific rigor.
Highest-signal resume keywords
PBPK ModelingPKPD ModelingRegulatory SubmissionsSimcyp ProficiencyCross-Functional Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PharmacokineticsPharmacodynamicsADME PrinciplesDose ProjectionsData Evaluation
Soft Skills
Excellent CommunicationCollaborative LeadershipAdaptabilityInfluencing SkillsProject Management
Tools & Technologies
SimcypGastroPlusPhoenix WinNonlinNONMEM
Certifications & Qualifications
PhDPharmD
Industry Keywords
IND-Enabling ProgramsCNS ProgramsNeuroscienceRare DiseaseFDA RegulationsEMA RegulationsICH Guidelines
About the role
Key responsibilities & impact- 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
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 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
Comp & perks- 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