Senior Advisor, Clinical Science

Job Description:

• Serve as clinical scientist on one or more late-stage Phase 2–3 global clinical trials for Orexin-targeted programs in sleep/wake indications
• Support creation and review of clinical slides for internal and external meetings
• Assist in authoring protocols, Clinical Study Reports, Investigator Brochures, Development Safety Update Reports, and other key clinical study documents
• Serve as study scientific expert from study start-up through Clinical Study Report completion
• Support CRF design, enrollment monitoring, and patient profile review
• Liaise with Clinical Operations on site selection, site start-up, study management, and closeout
• Serve as primary contact for clinical inquiries from sites, CROs, site monitors, and health authorities
• Perform ongoing clinical data review to monitor safety, data integrity, protocol compliance, and study performance
• Serve as a scientific leader on cross-functional program and study teams
• Drive alignment and execution across functions for high-quality, timely study delivery
• Identify and address scientific, operational, and strategic risks and gaps
• Develop scientific insights and recommendations to inform clinical development strategy and decision-making
• Partner with biostatistics on SAP development and review and interpretation of final clinical study TLFs
• Support abstracts, posters, manuscripts, and scientific meeting presentations
• Provide scientific leadership with investigators, CROs, vendors, external experts, key opinion leaders, and scientific advisory boards
• Ensure organization, follow-through, and proactive management of deliverables

Requirements:

• Advanced scientific/clinical degree (PhD or PharmD) with 2+ years drug development experience in the biotech/pharma industry, OR BS/MS in a scientific discipline with 8+ years drug development experience in the biotech/pharma industry
• Strong scientific foundation in neuroscience/neurology required
• Understanding of clinical trial design, clinical data analysis, and drug development principles
• Demonstrated accountability for delivery on clinical studies
• Proven experience in 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
• Detail oriented with exceptional organizational skills
• Effective verbal and written communication skills
• Ability to identify issues, analyze situations, and provide effective solutions
• Demonstrated ability to partner with cross-functional teams in a fast-paced biotech environment

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 flexible spending accounts
• 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