[Hiring] Senior Advisor, Clinical Science @Lilly

Role Description

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.

• 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.

Qualifications

• 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).

Requirements

• 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

• Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $153,000 - $283,800.
• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).