Senior Advisor, Clinical Science
Eli Lilly and Company
Summary
Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.
Job description
Organization and Position Overview
Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.
We are seeking a Senior Advisor, Clinical Science to serve as the scientific partner to the study team and medical monitor in the execution and interpretation of primarily late-stage (Phase 2-3) clinical trials for our Orexin-targeted programs in sleep/wake indications. This individual will perform at the Associate Director level to bring clinical and scientific expertise to day-to-day study conduct, ensuring that studies are run in line with the protocol, compliant with internal processes, GCP/ICH and regulatory requirements, and in alignment with the broader 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.
- Primary point of contact for clinical inquiries from sites, CRO and site monitors, and health authority responses; answer or triage questions as appropriate.
- 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.
Basic 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 (e.g., protocols, IBs, CSRs, briefing documents).
Additional Preferences
- 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.
Work Location
The Senior Advisor, Clinical Science role is a remote role based in the US, with occasional travel.
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 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
- 401(k) Matching
- Pension
- Vacation Benefits
- Medical, Dental & Vision
- Prescription Drug Benefits
- Flexible Spending Accounts
- Life Insurance
- Death Benefits
- Employee Assistance Program
- Fitness Benefits
- Employee Clubs & Activities
- Company Bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.