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Senior Clinical Science Advisor, Orexin Trials
Lead clinical science for Phase 1/2 Orexin-targeted trials at Centessa Pharmaceuticals, shaping study strategy and interpreting emerging data. Partner across clinical, regulatory, translational, and safety teams to guide trial execution and scientific decisions.
Statele Unite ale Americii168.000 $ – 283.800 $ / an
RemoteNormă întreagăSeniorLimbă Obligatorie: englezăConsultant clinicGeneralDescriere
- Lead clinical science for early Phase 1/2 Orexin-targeted trials in neurodegenerative or neuropsychiatric indications.
- Help shape clinical development plans through study design, dose escalation and titration strategies, and data interpretation.
- Draft and review protocols, amendments, investigator brochures, eCRFs, completion guidance, SAP/TLF shells, and regulatory briefing materials.
- Guide studies from start-up through completion of the clinical study report.
- Oversee CRF design, enrollment monitoring, and review of patient profiles.
- Inform dose escalation and trial conduct by interpreting emerging safety, PK/PD, and biomarker data in real time.
- Offer scientific guidance in data reviews, safety committees, governance forums, and cross-functional discussions.
- Work with Clinical Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance.
- Align cross-functional teams to deliver high-quality studies on schedule.
- Work with Translational and Preclinical teams to bring biomarker and mechanistic hypotheses into trials and development plans.
- Spot and address scientific, operational, and strategic risks and gaps.
- Assess clinical safety, efficacy, PK/PD, and exploratory biomarker findings.
- Turn scientific findings into recommendations for clinical development and decision-making.
- Contribute to regulatory submissions, health authority responses, governance materials, and external scientific communications.
- Help prepare abstracts, posters, manuscripts, and presentations for scientific meetings and publications.
- Provide scientific guidance when working with investigators, CROs, vendors, and external experts.
- Lead or assist with investigator meetings and scientific training.
- Represent clinical science with key opinion leaders and scientific advisory boards.
- Coordinate deliverables across assigned studies and workstreams.
- Mentor and support junior clinical scientists as the role requires.
Cerințe
- Advanced scientific or clinical degree; PhD or PharmD strongly preferred.
- 8–10 years of clinical research or development experience in biotechnology or pharmaceuticals.
- Strong grounding in neuroscience or neurology.
- Experience in neurodegenerative or neuropsychiatric indications strongly preferred.
- Knowledge of Orexin biology or related sleep/wake and neurocircuitry mechanisms is a plus.
- In-depth understanding of trial design, clinical data analysis, and drug development.
- Experience leading or supporting Phase 1/2 trials.
- Ability to independently lead complex scientific workstreams and influence cross-functional teams in a fast-paced biotech setting.
- Track record of leading clinical and regulatory document development, including protocols, investigator brochures, clinical study reports, and briefing documents.
- Strong analytical skills and scientific judgment.
- Ability to turn emerging clinical, safety, and biomarker data into actionable insights.
- Excellent written and verbal communication skills.
- Ability to explain complex science clearly to varied audiences.
- Must be based in the United States.
- Available for occasional travel.
Beneficii
- Company bonus, based partly on company and individual performance.
- Company-sponsored 401(k) plan.
- Pension plan.
- Vacation benefits.
- Medical, dental, vision, and prescription drug coverage.
- Flexible benefits, including healthcare and/or dependent care flexible spending accounts.
- Life insurance and death benefits.
- Time off and leave benefits.
- Well-being support, including an employee assistance program, fitness benefits, and employee clubs and activities.
- Remote work arrangement.
- Occasional travel.