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 10/18/2026full-timeRemote • Massachusetts • United StatesSenior💰 $153,000 - $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, dose selection, and regulatory documentation. Proficient in utilizing advanced modeling techniques and collaborating effectively within cross-functional teams.

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 TheoryWorking Knowledge Of FDA, EMA, And ICH Guidance

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Hard Skills

Clinical PharmacologyPharmacokineticsPharmacometricsPK/PD AnalysisDose SelectionRegulatory DocumentationQuantitative ModelingIn Vitro-Clinical TranslationBiomarker Data IntegrationExposure-Response Analysis

Soft Skills

Excellent CommunicationStakeholder ManagementCross-Functional CollaborationProblem-SolvingScientific Oversight

Tools & Technologies

NONMEMPhoenix WinNonlin/NLMEMonolixRSimcypGastroPlusPK-SimQSP Modeling

Industry Keywords

BiotechPharmaceuticalDrug DevelopmentPhase 1-2 StudiesFirst-In-HumanDrug-Drug InteractionADMEMIDD PrinciplesTranslational MedicineClinical Development Plans

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
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, 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, and NDA/MAA
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 and participate in peer review of analyses and reports
Present findings to internal stakeholders and contribute to external scientific publications and presentations
Report to the Executive Director, Clinical Pharmacology
Build, evaluate, and explain quantitative models and take growing ownership of clinical pharmacology deliverables within project teams

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

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
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