Senior Advisor, Clinical Science
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Job Description
Clinical science advisor advancing Lilly subsidiary Centessa’s Orexin-targeted sleep-disorder trials. Leading late-stage study execution, data interpretation, and cross-functional clinical development strategy.
Responsibilities:
- Serve as clinical scientist on one or more late-stage (Phase 2-3) global clinical trials for Orexin-targeted sleep/wake programs
- Support creation and review of clinical slides for investigator meetings, SIVs, IDMCs, advisory boards, and other meetings
- Author or review protocols, Clinical Study Reports, Investigator Brochures, Development Safety Update Reports, and other study documents
- Serve as study scientific expert from startup through Clinical Study Report completion
- Support CRF design, enrollment monitoring, and patient profile review
- Liaise with Clinical Operations on site selection, startup, study management, and closeout
- Serve as primary contact for clinical inquiries from sites, CROs, site monitors, and health authorities
- Integrate clinical and regulatory strategy into global product development strategy
- Review clinical data for safety, data integrity, protocol compliance, and study performance
- Lead cross-functional collaboration with Clinical Operations, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance
- Identify and address scientific, operational, and strategic risks and gaps
- Develop scientific insights and recommendations for clinical development decisions
- Partner with biostatistics on SAP development and review and interpretation of final clinical study TLFs
- Support abstracts, posters, manuscripts, and scientific presentations
- Provide scientific leadership with investigators, CROs, vendors, external experts, key opinion leaders, and scientific advisory boards
- Manage deliverables across assigned studies and workstreams
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
- Understanding of clinical trial design, clinical data analysis, and drug development principles
- Demonstrated accountability for delivery on clinical studies
- Proven experience developing and authoring clinical and regulatory documents, including protocols, IBs, CSRs, and briefing documents
- Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms preferred
- Detail oriented with exceptional organizational skills
- Effective verbal and written communication skills
- Ability to identify issues, analyze situations, and provide effective solutions
- Ability to partner with cross-functional teams in a fast-paced biotech environment
- Role based in the United States
- Occasional travel
Benefits:
- Company bonus based 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
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
- Remote work with occasional travel
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