Senior Advisor, Clinical Pharmacology

Eli Lilly and Company

. Provide clinical pharmacology and PK/PD input to project teams, contributing to decisions on dose, patient population, and study design .

Posted 11/5/2026full-timeRemote • United StatesSenior💰 $168,000 - $268,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Pharmacology and Pharmacokinetics, with a strong focus on PK/PD analysis, model development, and regulatory submissions. Proficient in collaborating across multidisciplinary teams to support drug development and ensure compliance with FDA and EMA guidelines.

Highest-signal resume keywords

PhD Or PharmD In Clinical Pharmacology3+ Years Of Industry Experience In Clinical PharmacologyHands-On Proficiency With NONMEMSolid Working Knowledge Of PK/PD TheoryExcellent Communication And Stakeholder Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical PharmacologyPharmacokineticsPharmacometricsPK/PD AnalysisModel DevelopmentDose SelectionRegulatory SubmissionsIn Vitro-Clinical TranslationData AnalysisBiomarker Integration

Soft Skills

Problem-Solving AbilityAdaptabilityCuriosityGrowth MindsetStakeholder Management

Tools & Technologies

NONMEMPhoenix WinNonlin/NLMEMonolixRSimcypGastroPlusPK-SimQSP Modeling

Industry Keywords

FDA GuidanceEMA GuidanceICH M12ICH M15Drug DevelopmentTranslational MedicineFirst-In-Human RationalePopulation PK AnalysesClinical Development PlansCRO Oversight

About the role

Key responsibilities & impact

Provide clinical pharmacology and PK/PD input to project teams, contributing to decisions on dose, patient population, and study design
Conduct and interpret noncompartmental and population PK analyses for Phase 1–2 studies, including FIH, SAD/MAD, DDI, food effect, organ impairment, and patient studies
Develop structural models, evaluate covariates, and perform model diagnostics
Build and apply exposure–response and PK/PD analyses and PBPK models to support dose selection and drug–drug interaction risk assessment
Integrate nonclinical PK/PD, in vitro ADME data, and biomarker data to support human PK and dose projections, interspecies scaling, and first-in-human rationale
Draft PK/PD sections of clinical development plans, protocols, analysis plans, investigator brochures, study reports, and regulatory documents including IND, CTA, NDA, and MAA submissions
Collaborate with DMPK, translational sciences, clinical development, bioanalysis, biostatistics, regulatory affairs, and project leadership
Provide day-to-day scientific oversight of CRO and vendor deliverables
Participate in peer review of analyses and reports
Present findings to internal stakeholders and contribute to external scientific publications and presentations

Requirements

What you’ll need

PhD or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline, or a graduate degree in these areas with a strong demonstrated work history
3+ years of industry experience in clinical pharmacology or pharmacometrics within biotech, pharmaceutical, or drug development environments; relevant postdoctoral experience considered
Solid working knowledge of PK/PD theory, ADME, DDI mechanisms including in vitro-to-clinical translation, and MIDD principles
Hands-on proficiency with NONMEM, Phoenix WinNonlin/NLME, Monolix, R, or similar software
Ability to choose an appropriate analysis, troubleshoot model problems, and clearly explain a model's assumptions and limitations
Working knowledge of FDA, EMA, and ICH guidance relevant to clinical pharmacology, including ICH M12 and ICH M15
Interest in translational medicine, including target engagement, biomarkers, and nonclinical-to-clinical translation
Ability to work effectively in cross-functional, matrixed environments
Excellent communication and stakeholder management skills
Exposure to PBPK platforms such as Simcyp, GastroPlus, or PK-Sim, or QSP modeling, is a plus
Curiosity, passion for the work, adaptability, problem-solving ability, growth mindset, and interest in artificial intelligence and digital innovation

Benefits

Comp & perks

Company bonus depending in part on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
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 open to all employees