Senior Advisor – Clinical Science

Eli Lilly and Company  ยท  via Happy Techies
๐Ÿ’ฐ $153,000 - $268,400/yr ๐ŸŒŽ Remote

Job Description:

  • 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, study design, dose-escalation/titration strategy, and data interpretation
  • Lead development, authorship, and review of clinical and cross-functional documents
  • Serve as study medical/scientific lead from study start-up through clinical study report completion
  • Drive dose-escalation and study conduct discussions through review of 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 alignment and execution across functions for timely study delivery
  • Integrate biomarker and mechanistic hypotheses into clinical studies and development strategy
  • Identify and address scientific, operational, and strategic risks and gaps
  • Review and interpret clinical safety, efficacy, PK/PD, and exploratory biomarker data
  • Develop scientific insights and recommendations for clinical development decisions
  • Contribute to regulatory submissions, health authority responses, governance materials, and external scientific communications
  • Support abstracts, posters, manuscripts, and scientific meeting presentations
  • Lead interactions with investigators, CROs, vendors, external experts, key opinion leaders, and scientific advisory boards
  • Lead or support investigator meetings and scientific training sessions
  • Ensure organization and proactive management of study deliverables and workstreams
  • Mentor junior clinical scientists, depending on level

Requirements:

  • Advanced scientific/clinical degree (PhD or PharmD)
  • 8โ€“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
  • 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
  • Ability to independently lead complex scientific workstreams and influence cross-functional teams in a fast-paced biotech environment
  • Experience leading the development and authorship of clinical and regulatory documents, including protocols, IBs, CSRs, and briefing documents
  • Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms
  • Strong analytical and scientific interpretation skills
  • Excellent written and verbal communication skills
  • Ability to communicate complex scientific concepts to diverse audiences

Benefits:

  • Company bonus depending partly on company and individual performance
  • Company-sponsored 401(k)
  • Pension
  • Vacation benefits
  • Medical benefits
  • Dental benefits
  • Vision benefits
  • Prescription drug benefits
  • Healthcare and/or dependent day care flexible spending accounts
  • Life insurance and death benefits
  • Time off and leave of absence benefits
  • Employee assistance program
  • Fitness benefits
  • Employee clubs and activities
  • Remote work with occasional travel