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Senior Advisor, Clinical Science
Eli Lilly and Company. Serve as clinical scientist lead on one or more early-stage Phase 1/2 clinical trials for Orexin-targeted programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial design and execution, particularly in early-phase studies, with a strong foundation in neuroscience and neurodegeneration. Proven ability to lead cross-functional teams and develop regulatory documents while providing scientific insights for clinical development strategies.
Highest-signal resume keywords
Clinical Trial DesignNeuroscience ExpertiseRegulatory Document DevelopmentCross-Functional LeadershipClinical Data Analysis
ATS Keywords
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Hard Skills
Clinical ResearchClinical DevelopmentData InterpretationDose-Escalation StrategyBiomarker IntegrationScientific LeadershipClinical Data AnalysisRegulatory SubmissionsProtocol DevelopmentPharmacovigilance
Soft Skills
Excellent Communication SkillsMentoringProactive Management
Certifications & Qualifications
PhDPharmD
Industry Keywords
BiotechnologyPharmaceutical IndustryNeurodegenerationNeuropsychiatric IndicationsOrexin BiologyPhase 1/2 Clinical TrialsSafety Review CommitteesGovernance ForumsScientific Advisory BoardsHealth Authority Responses
About the role
Key responsibilities & impact- Serve as clinical scientist lead on one or more early-stage Phase 1/2 clinical trials for Orexin-targeted programs
- Contribute to clinical development plan strategy, including study design, dose-escalation/titration strategy, and data interpretation
- Lead development, authorship, and review of clinical and cross-functional documents, including protocols, amendments, investigator brochures, eCRFs, completion guidelines, SAP/TLF shells, and regulatory briefing materials
- Serve as study medical/scientific lead from study start-up through clinical study report completion
- Drive dose-escalation and study conduct discussions through review and interpretation of emerging safety, PK/PD, and biomarker data
- Provide scientific leadership in data review meetings, safety review committees, governance forums, and cross-functional discussions
- Partner with Clinical Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance
- Drive cross-functional alignment and execution for timely, high-quality study delivery
- Integrate biomarker and mechanistic hypotheses into clinical studies and broader development strategy
- Identify and address scientific, operational, and strategic risks and gaps
- Review and interpret clinical data, including safety, efficacy, PK/PD, and exploratory biomarkers
- Develop scientific insights and recommendations for clinical development strategy and decision-making
- Contribute to regulatory submissions, health authority responses, governance materials, and external scientific communications
- Support abstracts, posters, manuscripts, and presentations for scientific meetings and publications
- Provide scientific leadership with investigators, CROs, vendors, external experts, key opinion leaders, and scientific advisory boards
- Lead or support investigator meetings and scientific training sessions
- Ensure organization, follow-through, and proactive management of deliverables
- Mentor and support junior clinical scientists, scope dependent on level
Requirements
What you’ll need- Advanced scientific/clinical degree (PhD or PharmD strongly preferred)
- 8–10 years of experience in clinical research or clinical development within the biotechnology or pharmaceutical industry
- Strong scientific foundation in neuroscience/neurology required
- Experience in neurodegeneration and/or neuropsychiatric indications strongly preferred
- Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms is a plus
- Deep understanding of clinical trial design, clinical data analysis, and drug development principles
- Direct experience leading or supporting early-phase (Phase 1/2) clinical trials
- Demonstrated ability to independently lead complex scientific workstreams and influence cross-functional teams
- Proven experience leading the development and authorship of clinical and regulatory documents, such as protocols, IBs, CSRs, and briefing documents
- Strong analytical and scientific interpretation skills
- Excellent written and verbal communication skills
- Ability to work remotely from the United States
- Occasional travel
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
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
- Remote work arrangement
- Occasional travel