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-stage Phase 1/2 clinical trials focused on Orexin-targeted programs.

• Contribute to the strategy of the clinical development plan, which includes study design, dose-escalation/titration strategy, 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 medical/scientific lead from the initiation of the study through to the completion of the clinical study report.

• Facilitate dose-escalation and study conduct discussions by reviewing and interpreting emerging safety, 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.

• Drive alignment and execution across functions for the timely and high-quality delivery of studies.

• Integrate biomarker and mechanistic hypotheses into clinical studies and the broader development strategy.

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

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

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

• 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 and publications.

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

• Lead or support investigator meetings and scientific training sessions.

• Ensure organization, follow-through, and proactive management of deliverables.

• Mentor and support junior clinical scientists, with the scope dependent on level.

⛳️ Requirements

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

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

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

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

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

• A deep 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.

• Proven ability to independently lead complex scientific workstreams and influence cross-functional teams.

• Demonstrated experience in developing and authoring clinical and regulatory documents, including protocols, IBs, CSRs, and briefing documents.

• Strong analytical skills and the ability to interpret scientific data effectively.

• Excellent written and verbal communication skills.

• Ability to work remotely from the United States.

• Willingness to travel occasionally.

🏝️ Benefits

• Company bonus based in part on individual and company 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.

• Certain 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 available.

• Occasional travel required.