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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 .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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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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