Note: The job is a remote job and is open to candidates in USA. Eli Lilly and Company, through its wholly owned subsidiary Centessa Pharmaceuticals, develops orexin receptor 2 agonists for sleep-wake disorders and related neurological conditions. The Senior Advisor, Clinical Science serves as a scientific partner to clinical study teams and medical monitors, supporting late-stage clinical trial execution, interpretation, data review, document development, 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 programs in sleep/wake indications
- Support the creation of and/or review of clinical slides for internal and external meetings (e.g. Investigator Meetings, SIVs, IDMCs, Advisory Boards, etc.)
- Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Development Safety Update Reports etc
- Serve as study scientific expert from study start-up through clinical study report completion, including CRF design, enrollment monitoring, and patient profile review
- Primary liaison for internal Clinical Operations for site selection, site start-up activities, study management and closeout activities, etc
- Primary point of contact for clinical inquiries from sites, CRO and site monitors, and health authority responses; answer or triage questions as appropriate integration of clinical/regulatory strategy into global product development strategy
- Perform ongoing clinical data review to monitor safety, data integrity, protocol compliance, and study performance throughout trial execution
- Serve as a core scientific leader on cross-functional program/study teams, partnering closely with Clinical Operations, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance
- Drive alignment and execution across functions to support high-quality, timely study delivery
- Proactively identify and address scientific, operational, and strategic risks and gaps
- Develop clear scientific insights and recommendations to inform clinical development strategy and decision-making
- Partner with biostatistics in the development and review of the SAP, and responsible for review and interpretation of final clinical study TLFs
- Support preparation of abstracts, posters, manuscripts, and presentations for scientific meetings and publications
- Provide scientific leadership in interactions with investigators, CROs, vendors, and external experts to support high-quality trial execution
- Represent clinical science in interactions with key opinion leaders and scientific advisory boards in disorders of sleep/wake
- Ensure strong organization, follow-through, and proactive management of deliverables across assigned studies and workstreams
Skills
- 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 (e.g., protocols, IBs, CSRs, briefing documents)
- Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms
- Detail oriented with exceptional organizational skills
- Effective communicator with strong verbal and written 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
- Remote role based in the US
- Company bonus, depending in part on company and individual performance
- Eligibility for a company-sponsored 401(k)
- Pension
- Vacation benefits
- Eligibility for 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 an employee assistance program, fitness benefits, and employee clubs and activities
- Employee resource groups (ERGs) offering strong support networks for their members
Company Overview
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