Senior Advisor, Clinical Science (remote)

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. Activities include, but are not limited to, protocol development; scientific leadership for study startup; trial execution; driving recruitment; study and data monitoring; and data analysis upon close out. This role will serve as a key cross-functional partner to Clinical Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance.

This role will report to the Executive Director, Clinical Development.

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.
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• 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.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$153,000 - $268,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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