Senior Advisor, Clinical Science

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
• Monitor enrollment and review patient profiles
• 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 cross-functional alignment and 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, and external experts
• Lead or support investigator meetings and scientific training sessions
• Represent clinical science with key opinion leaders and scientific advisory boards
• Manage deliverables across assigned studies and workstreams
• Mentor junior clinical scientists

Requirements:

• 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 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
• Ability to independently lead complex scientific workstreams and influence cross-functional teams
• Experience leading the development and authorship of clinical and regulatory documents
• Strong analytical and scientific interpretation skills
• Excellent written and verbal communication skills
• Role based in the US

Benefits:

• Company bonus depending, in part, 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 arrangement
• Occasional travel