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Senior Clinical Science Advisor
Guide clinical science for Centessa’s orexin-targeted sleep disorder trials, supporting late-stage study delivery, data interpretation, and clinical development strategy.
Statele Unite ale Americii153.000 $ – 268.400 $ / an
RemoteNormă întreagăSeniorLimbă Obligatorie: englezăConsultant clinicGeneralDescriere
- Serve as clinical scientist for one or more global Phase 2–3 trials in orexin-targeted sleep and wake programs.
- Prepare and review clinical presentations for investigator meetings, site initiation visits, independent data monitoring committees, advisory boards, and other meetings.
- Write or review protocols, Clinical Study Reports, Investigator Brochures, Development Safety Update Reports, and other study documents.
- Provide scientific expertise throughout each study, from startup to completion of the Clinical Study Report.
- Support case report form design, enrollment monitoring, and patient profile review.
- Coordinate with Clinical Operations on site selection, study startup, management, and closeout.
- Act as the main contact for clinical questions from sites, contract research organizations, site monitors, and health authorities.
- Align clinical and regulatory plans with the global product development strategy.
- Assess clinical data for safety, integrity, protocol compliance, and study performance.
- Lead collaboration across Clinical Operations, Regulatory Affairs, Biostatistics, and Safety and Pharmacovigilance.
- Identify and address scientific, operational, and strategic risks and gaps.
- Develop scientific insights and recommendations to inform clinical development decisions.
- Work with biostatistics on statistical analysis plan development, and review and interpret final study tables, listings, and figures.
- Contribute to abstracts, posters, manuscripts, and scientific presentations.
- Provide scientific leadership with investigators, contract research organizations, vendors, external experts, key opinion leaders, and scientific advisory boards.
- Oversee deliverables across assigned studies and workstreams.
Cerințe
- PhD or PharmD with at least 2 years of biotech or pharmaceutical drug development experience, or a BS/MS in a scientific field with at least 8 years of such experience.
- Strong scientific background in neuroscience or neurology.
- Knowledge of clinical trial design, clinical data analysis, and drug development principles.
- Track record of taking responsibility for clinical study delivery.
- Experience developing and writing clinical and regulatory documents, including protocols, Investigator Brochures, Clinical Study Reports, and briefing documents.
- Knowledge of orexin biology or related sleep/wake and neurocircuitry mechanisms is preferred.
- Strong attention to detail and organizational skills.
- Clear, effective written and verbal communication.
- Ability to spot issues, assess situations, and develop effective solutions.
- Ability to collaborate across functions in a fast-paced biotech setting.
- Must be based in the United States.
- Occasional travel is required.
Beneficii
- Company bonus partly tied to company and individual performance.
- Company-sponsored 401(k) plan.
- Pension plan.
- Vacation benefits.
- Medical, dental, vision, and prescription drug coverage.
- Flexible spending accounts for healthcare and/or dependent day care.
- Life insurance and death benefits.
- Time off and leave benefits.
- Employee assistance program.
- Fitness benefits.
- Employee clubs and activities.
- Remote work with occasional travel.