Senior Advisor, Clinical Science

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a clinical scientist for one or more late-stage Phase 2–3 global clinical trials focused on Orexin-targeted programs in sleep/wake conditions.

• Assist in the creation and review of clinical presentation materials for both internal and external meetings.

• Contribute to the drafting of protocols, Clinical Study Reports, Investigator Brochures, Development Safety Update Reports, and other essential clinical study documents.

• Function as the scientific expert for the study from the initiation phase through to the completion of the Clinical Study Report.

• Aid in the design of CRFs, monitor enrollment, and review patient profiles.

• Collaborate with Clinical Operations on site selection, startup, management, and study closure.

• Act as the primary point of contact for clinical inquiries from sites, CROs, site monitors, and health authorities.

• Conduct ongoing reviews of clinical data to ensure safety, data integrity, protocol compliance, and study performance.

• Provide scientific leadership on cross-functional program and study teams.

• Facilitate alignment and execution across functions to ensure high-quality and timely study delivery.

• Identify and address scientific, operational, and strategic risks and gaps.

• Generate scientific insights and recommendations to guide clinical development strategy and decision-making.

• Collaborate with biostatistics on the development of the Statistical Analysis Plan and on the review and interpretation of final clinical study tables, listings, and figures.

• Support the preparation of abstracts, posters, manuscripts, and presentations for scientific meetings.

• Provide scientific leadership in interactions with investigators, CROs, vendors, external experts, key opinion leaders, and scientific advisory boards.

• Ensure organized follow-through and proactive management of deliverables.

⛳️ Requirements

• An advanced scientific or clinical degree (PhD or PharmD) with over 2 years of drug development experience in the biotech or pharmaceutical industry, OR a BS/MS in a scientific discipline with more than 8 years of drug development experience in the biotech or pharmaceutical sectors.

• A robust scientific background in neuroscience or neurology is essential.

• Knowledge of clinical trial design, clinical data analysis, and principles of drug development is required.

• Proven track record of accountability for delivering on clinical studies.

• Demonstrated experience in the development and authorship of clinical and regulatory documents, including protocols, Investigator Brochures, Clinical Study Reports, and briefing documents.

• Familiarity with Orexin biology or related mechanisms in sleep/wake and neurocircuitry is preferred.

• Highly detail-oriented with outstanding organizational abilities.

• Strong verbal and written communication skills.

• Capacity to identify problems, analyze circumstances, and provide effective solutions.

• Proven ability to collaborate with cross-functional teams in a dynamic biotech environment.

🏝️ Benefits

• Company bonus based on both individual and company performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Prescription drug coverage.

• Healthcare flexible spending accounts.

• Dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Employee assistance program.

• Fitness benefits.

• Employee clubs and activities.

• Options for remote work.

• Occasional travel opportunities.