(Associate) Director, Clinical Science
About The Position
Centessa Pharmaceuticals is seeking an (Associate) Director, Clinical Science to provide scientific and clinical leadership for the design, execution, and interpretation of early-stage (Phase 1/2) clinical trials for their Orexin-targeted programs in neurodegeneration and neuropsychiatric indications. This individual will serve as a scientific leader and key cross-functional partner to Clinical Development, Clinical Operations, Translational Science, Regulatory Affairs, Biostatistics, and Safety/Pharmacovigilance, with significant responsibility for study-level scientific strategy and execution. Reporting to the Executive Director, Clinical Development, this individual will lead authorship of key clinical and regulatory documents, drive ongoing clinical data review and interpretation, contribute to dose-escalation and development strategy decisions, and provide scientific leadership across internal governance and cross-functional forums.
Requirements
- Advanced scientific/clinical degree (PhD or PharmD) required.
- 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).
- Strong analytical and scientific interpretation skills, including the ability to synthesize emerging clinical, safety, and biomarker data into actionable insights.
- Excellent written and verbal communication skills, with the ability to clearly communicate complex scientific concepts to diverse audiences.
Nice To Haves
- Familiarity with Orexin biology or related sleep/wake and neurocircuitry mechanisms a plus.
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 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).
Benefits
- 401(k) plan
- company-sponsored medical, dental, vision, and life insurance
- generous paid time off
- health and wellness program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
