Senior Advisor, Clinical Science

Responsibilities

• Serve as clinical scientist lead on one or more early-stage (Phase 1/2) clinical trials for Orexin-targeted programs in neurodegeneration and/or neuropsychiatric indications.
• Contribute to clinical development plan strategy, including study design, dose-escalation/titration strategy, and data interpretation.
• Lead the development, authorship, and review of key clinical and cross-functional documents, including protocols, amendments, investigator brochures, eCRFs, completion guidelines, SAP/TLF shells, and regulatory briefing materials.
• Serve as study medical/scientific lead from study start-up through clinical study report completion, including CRF design, enrollment monitoring, and patient profile review.
• Drive dose-escalation and study conduct discussions through real-time review and interpretation of emerging safety, PK/PD, and biomarker data.
• Provide scientific leadership and recommendations in data review meetings, safety review committees, governance forums, and cross-functional team discussions.
• Serve as a core scientific leader on cross-functional program/study teams, partnering closely with Clinical Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance.
• Drive alignment and execution across functions to support high-quality, timely study delivery.
• Collaborate with Translational and Preclinical teams to integrate biomarker and mechanistic hypotheses into clinical studies and broader development strategy.
• Proactively identify and address scientific, operational, and strategic risks and gaps.
• Lead ongoing review and interpretation of clinical data, including safety, efficacy, PK/PD, and exploratory biomarkers.
• Develop clear scientific insights and recommendations to inform clinical development strategy and decision-making.
• Contribute to regulatory submissions, health authority responses, internal governance materials, and external scientific communications.
• Support preparation of abstracts, posters, manuscripts, and presentations for scientific meetings and publications.
• Provide scientific leadership in interactions with investigators, CROs, vendors, and external experts to support high-quality trial execution.
• Lead or support investigator meetings and scientific training sessions.
• Represent clinical science in interactions with key opinion leaders and scientific advisory boards in neurodegeneration and neuropsychiatric disease areas.
• Ensure strong organization, follow-through, and proactive management of deliverables across assigned studies and workstreams.
• Mentor and support the development of junior clinical scientists (scope dependent on level).

Basic Qualifications

• Advanced scientific/clinical degree (PhD or PharmD strongly preferred)
• 8-10 years of experience in clinical research or clinical development within the biotechnology or pharmaceutical industry.
• Strong scientific foundation in neuroscience/neurology required; experience in neurodegeneration and/or neuropsychiatric indications strongly preferred.
• Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms a plus.
• Deep understanding of clinical trial design, clinical data analysis, and drug development principles, with direct experience leading or supporting early-phase (Phase 1/2) clinical trials.
• Demonstrated ability to independently lead complex scientific workstreams and influence cross-functional teams in a fast-paced biotech environment.
• Proven experience leading the development and authorship of clinical and regulatory documents (e.g., protocols, IBs, CSRs, briefing documents).
• Strong analytical and scientific interpretation skills, including the ability to synthesize emerging clinical, safety, and biomarker data into actionable insights.
• Excellent written and verbal communication skills, with the ability to clearly communicate complex scientific concepts to diverse audiences.

Work Location: The Senior Advisor, Clinical Science role is a remote role based in the US, with occasional travel.