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Associate Vice President – Early Development Clinical Research Physician, Neuroscience
Eli Lilly and Company. Serve as clinical lead to progress multiple early clinical assets into first-in-human studies and support further development through clinical pharmacology and mechanistic studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial design and conduct, particularly in early clinical development and clinical pharmacology, while ensuring compliance with regulatory standards and safety assessments. Possesses strong communication and interpersonal skills to effectively engage with stakeholders and lead clinical teams.
Highest-signal resume keywords
Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.)Clinical Trial Design and ConductClinical Pharmacology ExpertiseNeuroscience Drug DevelopmentRegulatory Compliance (FDA, ICH, GCPs)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial DesignClinical PharmacologyBiomarker QualificationStatistical MethodsSafety AssessmentInvestigator ManagementPharmacovigilanceData AnalysisRegulatory DocumentationFirst-in-Human Studies
Soft Skills
Strong Communication SkillsInterpersonal SkillsOrganizational SkillsTeamworkNegotiation Skills
Certifications & Qualifications
Board Eligible or Certified in Specialty/Subspecialty
Industry Keywords
Pharmaceutical Industry ExperienceNeuroscience ResearchNeurodegenerationPain ResearchGenetic Therapy Modalities
About the role
Key responsibilities & impact- Serve as clinical lead to progress multiple early clinical assets into first-in-human studies and 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 patient-safety requirements
- Review protocols, study reports, publications, data dissemination, product labels, grant submissions, and contracts
- Engage with regulatory and governmental agencies and external clinical thought leaders
- Ensure medical-team activities comply with local and international regulations, GCPs, company standards, Lilly policies, and medical research principles
- Work with basic research scientists to plan preclinical studies and develop biomarker plans
- Provide scientific and medical support to study teams and departments
- Contribute to clinical development strategy and plans for clinical compounds
- Support first-in-human dosing studies, Phase 2 and 3 planning, and biopharmaceutical submission planning
- Collaborate with Global Patient Safety, PK/PD, ADME, statistics, modeling, and other functional teams
- Design and oversee clinical pharmacology, biomarker qualification, mechanistic, and biopharmaceutical studies
- Create and oversee study protocols and study-conduct documents
- 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 study initiation and conduct requirements, including ethics review, informed consent, and regulatory approvals
- Participate in study start-up meetings and train investigators and site personnel
- Support clinical trial managers, monitors, investigators, and ethics boards during study conduct
- Monitor patient safety and track and follow up on adverse events
- Implement pharmacovigilance actions with global patient safety
- Oversee third-party organizations supporting study execution
- Address scientific questions from external healthcare professionals
- Participate in clinical trial registry reporting, data analysis, publications, symposia, advisory boards, and final reports
- Prepare clinical reports and regulatory documentation, including IND medical sections 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 medical strategies for commercialization, business development, payers, patients, and healthcare providers
- Establish 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
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 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 hiring country
- U.S.-trained physicians must have achieved board eligibility or certification
- At least ten (10) years of pharmaceutical industry experience, or similar, relevant to clinical trial design and conduct of first-in-human and Phase 1 studies
- Fluent in English, written and verbal
- Expertise in early clinical development, including clinical pharmacology
- Expertise in neuroscience drug development
- Ability to engage in domestic and international travel approximately 10–15%
- Knowledge of clinical trial design and conduct, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety assessment, and investigator/site management
- Ability to comply with FDA, ICH, CPMP, GCPs, company standards, policies, and medical research principles
- Strong communication, interpersonal, organizational, teamwork, and negotiation skills
- Ability to influence others within teams and matrix environments
- Pharmaceutical company experience preferable
- Clinical and/or research experience in neuroscience, neurodegeneration, and/or pain research preferable
- Broad clinical pharmacology experience preferable
- Experience with genetic therapy modalities such as siRNA, ASO, and gene therapy preferable
- Additional scientific training or degree (M.S., Ph.D.) preferable
Benefits
Comp & perks- Company bonus depending partly 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
- Employee resource groups (ERGs)
- Disability accommodation support during the application process