Senior Advisor, Clinical Science

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

📋 Description

• Act as the clinical scientist leader for one or more early-stage Phase 1/2 clinical trials focusing on Orexin-targeted programs related to neurodegeneration and/or neuropsychiatric conditions.

• Contribute to the clinical development plan strategy, which encompasses study design, dose-escalation/titration strategies, and data interpretation.

• Oversee the development, authorship, and review of clinical and cross-functional documents, including protocols, amendments, investigator brochures, eCRFs, completion guidelines, SAP/TLF shells, and regulatory briefing materials.

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

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

• Facilitate dose-escalation and study conduct discussions by conducting real-time reviews and interpretations of emerging safety, PK/PD, and biomarker data.

• Offer scientific leadership and recommendations 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 execution for the timely and high-quality delivery of studies.

• Work with Translational and Preclinical teams to incorporate biomarker and mechanistic hypotheses into clinical studies and development strategies.

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

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

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

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

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

• Provide scientific leadership in engagements with investigators, CROs, vendors, and external experts.

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

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

• Manage deliverables across assigned studies and workstreams.

• Mentor and support junior clinical scientists, depending on the scope of work.

⛳️ Requirements

• Advanced scientific or clinical degree; a PhD or PharmD is highly preferred.

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

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

• Experience in neurodegeneration and/or neuropsychiatric indications is strongly favored.

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

• Comprehensive understanding of clinical trial design, clinical data analysis, and drug development processes.

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

• Demonstrated capability to independently lead complex scientific workstreams and influence cross-functional teams in a dynamic biotech environment.

• Established experience in developing and authoring clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, and briefing materials.

• Strong analytical and scientific interpretation abilities.

• Capacity to synthesize emerging clinical, safety, and biomarker data into actionable insights.

• Excellent written and verbal communication skills.

• Ability to convey complex scientific concepts clearly to diverse audiences.

• 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 benefits.

• Vacation benefits.

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

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

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

• Remote work arrangement.

• Occasional travel required.