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 focusing on Orexin-targeted programs related to sleep/wake disorders.

• Assist in the development and evaluation of clinical presentation materials for both internal and external engagements, including Investigator Meetings, Site Initiation Visits (SIVs), Independent Data Monitoring Committees (IDMCs), and Advisory Boards.

• Contribute to the drafting of protocols, Clinical Study Reports, Investigator Brochures, and Development Safety Update Reports.

• Serve as the scientific authority throughout the study lifecycle, from initiation to the completion of the clinical study report, which includes designing Case Report Forms (CRFs), monitoring enrollment, and reviewing patient profiles.

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

• Act as the primary contact for clinical inquiries from sites, Contract Research Organizations (CROs), site monitors, and regulatory authorities.

• Conduct ongoing clinical data assessments to ensure safety, data integrity, protocol adherence, and overall study performance.

• Work alongside Clinical Operations, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance within cross-functional program and study teams.

• Facilitate alignment and execution among different functions to ensure timely and high-quality study completion.

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

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

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

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

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

• Ensure organized, proactive management of deliverables across assigned studies and workstreams.

• Report directly to the Executive Director of Clinical Development.

⛳️ Requirements

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

• A solid scientific foundation in neuroscience/neurology is essential.

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

• Proven track record of accountability for the delivery of clinical studies.

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

• Familiarity with Orexin biology or associated sleep/wake and neurocircuitry mechanisms is advantageous.

• Strong attention to detail and exceptional organizational abilities are necessary.

• Excellent verbal and written communication skills are required.

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

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

• This role is based in the US with occasional travel requirements.

🏝️ Benefits

• Company bonus that is partially based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Paid time off and leave of absence benefits.

• Well-being benefits, which include an employee assistance program, fitness benefits, and various employee clubs and activities.