Senior Advisor, Clinical Science

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

📋 Description

• Act as a clinical scientist on multiple late-stage (Phase 2-3) global clinical trials focused on Orexin-targeted sleep/wake initiatives.

• Assist in the development and evaluation of clinical presentations for investigator meetings, site initiation visits (SIVs), independent data monitoring committees (IDMCs), advisory boards, and other gatherings.

• Write or review protocols, Clinical Study Reports, Investigator Brochures, Development Safety Update Reports, and various study documents.

• Function as the scientific expert throughout the study lifecycle, from initiation to the completion of the Clinical Study Report.

• Aid in the design of case report forms (CRFs), monitor enrollment, and review patient profiles.

• Collaborate with Clinical Operations regarding site selection, study initiation, management, and closeout processes.

• Act as the primary contact for clinical inquiries from sites, contract research organizations (CROs), site monitors, and health authorities.

• Integrate clinical and regulatory strategies into the global product development framework.

• Evaluate clinical data for safety, data integrity, protocol adherence, and study performance metrics.

• Lead collaborative efforts across Clinical Operations, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance.

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

• Generate scientific insights and recommendations to guide clinical development decisions.

• Collaborate with biostatistics on the development of Statistical Analysis Plans (SAP) and the review and interpretation of final clinical study tables, listings, and figures (TLFs).

• Support the creation of abstracts, posters, manuscripts, and scientific presentations.

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

• Oversee deliverables across assigned studies and workstreams.

⛳️ Requirements

• Advanced scientific or clinical degree (PhD or PharmD) with a minimum of 2 years of experience in drug development within the biotech or pharmaceutical industry, or a BS/MS in a scientific field with at least 8 years of relevant drug development experience.

• Strong scientific background in neuroscience or neurology.

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

• Proven track record of accountability in delivering clinical studies.

• Demonstrated experience in developing and authoring clinical and regulatory documents, including protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), and briefing documents.

• Preference for familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms.

• Detail-oriented with excellent organizational skills.

• Strong verbal and written communication abilities.

• Capable of identifying issues, analyzing situations, and providing effective solutions.

• Ability to collaborate with cross-functional teams in a dynamic biotech setting.

• Position based in the United States.

• Willingness to travel occasionally.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Flexible spending accounts for healthcare and/or dependent day care.

• Life insurance and death benefits.

• Time off and leave of absence policies.

• Employee assistance program.

• Fitness benefits.

• Employee clubs and activities.

• Option for remote work with occasional travel requirements.