Director – Clinical Pharmacologist, Clinical Research Physician

Eli Lilly and Company

. Progress multiple early clinical assets into first-in-human studies or support further development through clinical pharmacology and mechanistic studies .

Posted 9/17/2026full-timeRemote • United StatesLead💰 $201,000 - $393,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial design and execution, regulatory compliance, and patient safety oversight. Proficient in collaborating with cross-functional teams and external stakeholders to advance clinical development strategies and ensure adherence to GCP and regulatory standards.

Highest-signal resume keywords

Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.)Clinical Trial Design and ConductRegulatory Compliance (FDA, ICH, GCP)Clinical Pharmacology ExperienceFluent in English (Written and Verbal)

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Protocol DevelopmentBiomarker Qualification StudiesStatistical MethodsPharmacovigilanceData AnalysisAdverse Event ReportingInvestigator ManagementClinical Program OversightRegulatory Report PreparationPhase 1 and Phase 2 Clinical Trials

Soft Skills

Strong Communication SkillsInterpersonal SkillsOrganizational SkillsTeamworkNegotiation Skills

Certifications & Qualifications

Board Eligible or Certified in Specialty/Subspecialty

Industry Keywords

Pharmaceutical Industry ExperienceEndocrinology ResearchDiabetes ResearchObesity ResearchCardiovascular ResearchRenal ResearchClinical PharmacologyLiaison Committee on Medical Education (LCME)Good Clinical Practice (GCP)Clinical Development Strategies

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Progress multiple early clinical assets into first-in-human studies or support further development through clinical pharmacology and mechanistic studies
Develop, conduct, and report global clinical trials for new compounds
Implement global clinical trials and report adverse events according to corporate patient-safety requirements
Review protocols, study reports, publications, data dissemination, product labels, grant submissions, contracts, and regulatory materials
Conduct outreach to external clinical customers and thought leaders
Ensure medical-team activities comply with local and international regulations, FDA, ICH, CPMP, GCPs, company standards, and Lilly policies
Work with basic research scientists to plan pre-clinical studies and develop biomarker plans
Serve as a scientific and medical resource for study teams and departments
Contribute to clinical development strategies and plans for clinical compounds
Support first-in-human dosing preparations, Phase 2 and 3 planning, and biopharmaceutical submission planning
Collaborate with Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics, and quantitative-science teams
Work with discovery research scientists on research strategies, candidate selection, and pre-clinical development
Collaborate with Brand Team and Business Unit colleagues on market differentiation and regulatory support
Design and oversee clinical pharmacology, mechanistic, development, and biomarker qualification studies
Develop protocols and study-conduct documents in accordance with GCP and local requirements
Collaborate with clinical research staff, statisticians, health outcomes scientists, consultants, and investigators
Participate in investigator identification and selection
Review risk profiles and informed-consent documents
Oversee ethical review, informed consent, regulatory approval/notification, study start-up, training, and site activities
Advise clinical trial managers, monitors, investigators, and ethical review boards during studies
Monitor patient safety, track and follow up adverse events, and implement pharmacovigilance actions
Provide oversight and partnership to third-party organizations for study execution
Address scientific questions from external healthcare professionals
Participate in clinical trial registry reporting, publication strategy, scientific communications, data analysis, final reports, and publications
Present clinical trial results to corporate committees, regulatory agencies, and external agencies
Prepare clinical reports and regulatory reports, including medical sections of INDs and Investigator Brochures
Support FDA advisory committee hearings, label discussions, and regulatory issue resolution
Develop and retain a scientifically excellent workforce and foster inclusion, innovation, and continual improvement
Support commercialization and medical strategies with business units, New Product Planning, and business development
Maintain relationships with external experts and opinion leaders
Support business-to-business and business-to-government activities as a medical expert
Contribute to ongoing strategic brand planning and understand market archetypes

Requirements

What you’ll need

Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.)
Non-U.S. trained physicians must have completed education and training at a medical school meeting Liaison Committee on Medical Education (LCME) requirements
Must be board eligible or certified in an appropriate specialty/subspecialty, or have completed comparable post-medical-school clinical training relevant to the country of hiring
U.S.-trained physicians must have achieved board eligibility or certification
At least two years of pharmaceutical industry experience, or similar, relevant to Phase 1 and Phase 2 clinical trial design and conduct
Experience with clinical programs, trials and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, and investigator/site management
Fluent in English, written and verbal
Ability to engage in domestic and international travel, approximately 10–15%
Demonstrated strong communication, interpersonal, organizational, teamwork, and negotiation skills
Demonstrated ability to influence others within teams and a matrix environment
Additional scientific training or degree (M.S., Ph.D.) preferable
Pharmaceutical company experience preferable
Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research preferable
Experience in Clinical Pharmacology preferable

Benefits

Comp & perks

Company bonus depending on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and 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
Disability accommodation support during the application process