Senior Advisor, Clinical Science (remote)

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. 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. 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 and/or review of clinical slides for internal and external meetings; Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Development Safety Update Reports; 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; Perform ongoing clinical data review to monitor safety, data integrity, protocol compliance, and study performance; Serve as a core scientific leader on cross-functional program/study teams; 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; 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

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)

Nice to have

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

Eligibility for company bonus (depending, in part, on company and individual performance); Company-sponsored 401(k); Pension; Vacation benefits; 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; Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)