Senior Advisor, Clinical Science
Posted 16hrs ago
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Job Description
Senior clinical science advisor leading Phase 1/2 Orexin-targeted trials for Centessa Pharmaceuticals. Driving clinical strategy, data interpretation, regulatory documents, and cross-functional execution.
Responsibilities:
- Serve as clinical scientist lead on one or more early-stage Phase 1/2 clinical trials for Orexin-targeted programs in neurodegeneration and/or neuropsychiatric indications
- Contribute to clinical development plan strategy, including study design, dose-escalation/titration strategy, and data interpretation
- Lead development, authorship, and review of 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
- Lead 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
- Partner with Clinical Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance
- Drive cross-functional alignment and execution for high-quality, timely study delivery
- Collaborate with Translational and Preclinical teams to integrate biomarker and mechanistic hypotheses into clinical studies and development strategy
- Identify and address scientific, operational, and strategic risks and gaps
- Review and interpret clinical safety, efficacy, PK/PD, and exploratory biomarker data
- Develop scientific insights and recommendations for clinical development strategy and decision-making
- Contribute to regulatory submissions, health authority responses, governance materials, and external scientific communications
- Support abstracts, posters, manuscripts, and presentations for scientific meetings and publications
- Provide scientific leadership in interactions with investigators, CROs, vendors, and external experts
- Lead or support investigator meetings and scientific training sessions
- Represent clinical science in interactions with key opinion leaders and scientific advisory boards
- Manage deliverables across assigned studies and workstreams
- Mentor and support junior clinical scientists, depending on scope
Requirements:
- 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 required
- Experience in neurodegeneration and/or neuropsychiatric indications strongly preferred
- Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms is a plus
- Deep understanding of clinical trial design, clinical data analysis, and drug development principles
- 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 development and authorship of clinical and regulatory documents, including protocols, IBs, CSRs, and briefing documents
- Strong analytical and scientific interpretation skills
- Ability to synthesize emerging clinical, safety, and biomarker data into actionable insights
- Excellent written and verbal communication skills
- Ability to clearly communicate complex scientific concepts to diverse audiences
- Role based in the United States
- Ability to travel occasionally
Benefits:
- Company bonus, depending in part on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
- Remote work arrangement
- Occasional travel
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