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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.
Združene države Amerike168.000 $ – 283.800 $ / leto
Na daljavoPolni delovni časSeniorZahtevani Jezik: angleščinaKlinični svetovalecSplošnoOpis
- 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.
Zahteve
- 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.
Ugodnosti
- 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.