Senior Clinical Scientist, Early-Phase Neuro (Remote)

BioSpace; Indianapolis (IN); Remoto; USD 168.000 - 284.000; Tempo pieno

Descrizione del lavoro

Lilly is seeking a Senior Advisor, Clinical Science to provide scientific leadership for early-stage (Phase 1/2) clinical trials in orexin-targeted programs. This role oversees study design, data interpretation, and regulatory documentation, working across Clinical Development, Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety.

Reporting to the Executive Director, Clinical Development, you will lead cross-functional teams, drive safety and biomarker reviews, and

Competenze

• 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; experience in neurodegeneration and/or neuropsychiatric indications preferred; familiarity with Orexin biology a plus.
• 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).
• Excellent written and verbal communication skills, with the ability to clearly communicate complex scientific concepts.

Mansioni

• Serve as clinical scientist lead on one or more early-stage (Phase 1/2) clinical trials for Orexin-targeted programs.
• 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.

Conoscenze

Neuroscience

Clinical trial leadership

Cross-functional collaboration

Regulatory writing

Formazione

PhD or PharmD in a relevant field

Descrizione del lavoro

Lilly is seeking a Senior Advisor, Clinical Science to provide scientific leadership for early-stage (Phase 1/2) clinical trials in orexin-targeted programs. This role oversees study design, data interpretation, and regulatory documentation, working across Clinical Development, Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety.

Reporting to the Executive Director, Clinical Development, you will lead cross-functional teams, drive safety and biomarker reviews, and