Remote Senior Director, Clinical Science - Orexin Trials

Eli Lilly and Company; Boston (MA); Remote; USD 153,000 - 268,000; Full time

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks a Senior Advisor / Director, Clinical Science to lead design, execution, and interpretation of early-stage (Phase 1/2) trials for Orexin-targeted programs in neurodegeneration and neuropsychiatric indications. Remote US role with cross-functional partnership.

Reporting to the Executive Director, Clinical Development, you will author protocols, IBs, CSRs, briefing documents, review safety/PK/PD data, guide study

Qualifications

• Advanced scientific/clinical degree (PhD or PharmD).
• 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.
• 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).

Responsibilities

• Serve as clinical scientist lead on early-stage trials.
• Contribute to 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).

Skills

Neuroscience

Clinical development

Early-phase trials

Scientific leadership

Education

PhD or PharmD

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks a Senior Advisor / Director, Clinical Science to lead design, execution, and interpretation of early-stage (Phase 1/2) trials for Orexin-targeted programs in neurodegeneration and neuropsychiatric indications. Remote US role with cross-functional partnership.

Reporting to the Executive Director, Clinical Development, you will author protocols, IBs, CSRs, briefing documents, review safety/PK/PD data, guide study