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Eli Lilly and Company

Senior Director, Clinical Pharmacology/Translational

Eli Lilly and Company

. Provide scientific and strategic leadership for translational clinical pharmacology across a diverse pipeline from early development through late-stage and registrational programs .

Posted 9/17/2026full-timeRemote • United StatesSenior💰 $165,000 - $242,000 per yearWebsite

Core Competencies

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Core Competencies

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Demonstrates expertise in clinical pharmacology with a focus on CNS drug development, including dose optimization, translational strategies, and regulatory submissions. Proven ability to lead cross-functional teams and mentor talent while ensuring compliance with global regulatory standards.

Highest-signal resume keywords
PhD, PharmD, Or MD In Clinical Pharmacology10+ Years Of Experience In Clinical PharmacologyExpertise In PK, PD, And PK/PD IntegrationProficiency With NONMEM, R, And Phoenix WinNonlinExperience Authoring Regulatory Submissions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Clinical Pharmacology Strategy DevelopmentDose OptimizationPopulation PK ModelingMechanistic PK/PD ModelingExposure-Response AnalysisDrug-Drug Interaction AssessmentBiopharmaceutics StudiesTranslational Biomarker IntegrationCNS Exposure ConsiderationsRegulatory Document Authoring
Soft Skills
Excellent Communication SkillsCollaboration SkillsLeadership SkillsMentoring SkillsAbility To Operate In Fast-Paced Environments
Tools & Technologies
NONMEMRPhoenix WinNonlinSimCyp
Industry Keywords
Translational Clinical PharmacologyCNS Drug DevelopmentRegulatory SubmissionsINDsCTAsNDAsBiopharmaClinical DevelopmentCRO ManagementGlobal Health Authorities

About the role

Key responsibilities & impact
  • Provide scientific and strategic leadership for translational clinical pharmacology across a diverse pipeline from early development through late-stage and registrational programs
  • Develop and execute clinical pharmacology strategies addressing CNS exposure, dose optimization, and translational relevance
  • Lead collection and interpretation of in vitro, in vivo, literature, competitive-source, and clinical data to develop a translational knowledge base
  • Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS-specific biomarkers
  • Lead model-informed drug development, including population PK, PK/PD, and exposure–response analyses
  • Assess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers
  • Lead clinical pharmacology strategy for CNS and neuroscience programs from first-in-human through registrational and post-marketing stages
  • Design, execute, and interpret clinical pharmacology studies, including FIH, multiple-ascending dose, DDI, biopharmaceutics, and patient studies
  • Serve as clinical pharmacology lead on program teams, clinical sub-teams, and trial working groups
  • Author and oversee clinical pharmacology sections of regulatory documents, including INDs, CTAs, IBs, and NDAs
  • Represent clinical pharmacology in interactions with FDA and other global health authorities
  • Partner with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs
  • Oversee CROs and external vendors conducting clinical pharmacology and modeling activities
  • Communicate and interpret clinical pharmacology results to internal stakeholders
  • Contribute to portfolio strategy, program prioritization, risk mitigation, and long-range clinical development planning for CNS assets
  • Serve as a subject-matter expert on clinical pharmacology
  • Mentor and develop clinical pharmacology talent
  • Ensure high-quality, submission-ready documentation aligned with global regulatory standards

Requirements

What you’ll need
  • PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline
  • 10+ years of experience in clinical pharmacology within biopharma, with demonstrated impact in translational science in drug development
  • Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessment
  • Extensive experience developing and executing clinical pharmacology strategies for early- through late-stage programs, including registrational support
  • Demonstrated experience applying quantitative clinical pharmacology and translational approaches, such as population PK and mechanistic PK/PD modeling, to inform CNS dose selection and optimization
  • Proficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent
  • Experience authoring and delivering clinical pharmacology components of regulatory submissions, including INDs, CTAs, and NDAs, and interacting with global health authorities
  • Strong understanding of translational PK, CNS exposure considerations, and biomarker integration in neuroscience drug development
  • Excellent communication, collaboration, and leadership skills with the ability to operate effectively in a fast-paced, matrixed environment

Benefits

Comp & perks
  • Company bonus eligibility based partly on company and individual performance
  • Pension plan eligibility
  • Vacation benefits
  • Healthcare benefits eligibility
  • Flexible benefits
  • 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