Senior Advisor, Clinical Science

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

📋 Description

• Act as the clinical scientist lead for one or more early-phase Phase 1/2 clinical trials focused on Orexin-targeted programs.

• Contribute to the strategic planning of clinical development, study design, dose-escalation/titration strategies, and data interpretation.

• Oversee the creation, authorship, and review of clinical and cross-functional documents.

• Serve as the medical/scientific lead throughout the study lifecycle, from initiation to the completion of the clinical study report.

• Monitor enrollment and assess patient profiles.

• Facilitate discussions on dose-escalation and study execution by reviewing safety, pharmacokinetic/pharmacodynamic (PK/PD), and biomarker data.

• Provide scientific leadership during data review meetings, safety review committees, governance forums, and cross-functional discussions.

• Collaborate with Clinical Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance teams.

• Ensure cross-functional alignment and the timely delivery of study milestones.

• Incorporate biomarker and mechanistic hypotheses into clinical studies and development strategies.

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

• Evaluate and interpret clinical safety, efficacy, PK/PD, and exploratory biomarker data.

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

• Contribute to regulatory submissions, responses to health authorities, governance materials, and external scientific communications.

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

• Lead interactions with investigators, contract research organizations (CROs), vendors, and external experts.

• Lead or assist in the organization of investigator meetings and scientific training sessions.

• Represent clinical science with key opinion leaders and scientific advisory boards.

• Manage deliverables across assigned studies and workstreams.

• Mentor junior clinical scientists.

⛳️ Requirements

• An advanced scientific or clinical degree (PhD or PharmD is strongly preferred).

• 8-10 years of experience in clinical research or clinical development within the biotechnology or pharmaceutical sectors.

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

• Experience in neurodegeneration and/or neuropsychiatric indications is highly preferred.

• Familiarity with Orexin biology or related mechanisms of sleep/wake and neurocircuitry is an advantage.

• A comprehensive understanding of clinical trial design, clinical data analysis, and drug development principles is required.

• Direct experience in leading or supporting early-phase (Phase 1/2) clinical trials.

• Capability to independently manage complex scientific workstreams and influence cross-functional teams.

• Experience in developing and authoring clinical and regulatory documents.

• Strong analytical skills and proficiency in scientific interpretation.

• Excellent written and verbal communication abilities.

• This role is based in the US.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical benefits.

• Dental benefits.

• Vision benefits.

• Prescription drug coverage.

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

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Employee assistance program.

• Fitness benefits.

• Opportunities for employee clubs and activities.

• Remote work options available.

• Occasional travel required.