Director, Clinical Operations

What if you could join a rapidly growing company and play a critical role in bringing new medicines to patients by helping scale the programmable infrastructure behind a new human cellular biology platform?

Vesalius Therapeutics is advancing a novel therapeutic program in Alzheimer’s disease. We are building an early clinical development capability designed to generate rigorous, decision-enabling human data and rapidly translate scientific insight into clinical proof of biological relevance. This program represents the first of our clinical pipeline, with additional therapeutic programs expected to advance toward the clinic over time.

Vesalius Therapeutics is seeking an experienced, hands-on Director of Clinical Operations to lead the operational execution of an innovative early-stage clinical development program in Alzheimer’s disease. This individual will play a critical role in translating clinical strategy into high-quality, efficiently executed studies and will partner closely with cross-functional leaders across Clinical Development, Clinical Pharmacology, Biostatistics, Data Management, Regulatory, and CMC.

The program is designed to progress from early clinical characterization in older adults to proof of biological relevance in an enriched Alzheimer’s disease population. Studies will integrate clinical pharmacology, objective physiologic and functional assessments, exploratory biomarkers, and quantitative measures of treatment response to support rapid, data-driven development decisions.

The ideal candidate thrives in a lean, high-ownership biotechnology environment, combines strong sponsor accountability with detailed execution, and can integrate multiple specialist vendors and scientific work streams into a disciplined clinical program.

• Own operational delivery of the clinical program from final protocol development through study start-up, enrollment, execution, database lock, and close-out.
• Lead execution of early clinical studies in older adults and subsequent studies in an early Alzheimer’s disease population, including complex randomized and crossover designs.
• Translate scientific objectives into operationally executable studies incorporating clinical pharmacology, pharmacokinetic, biomarker, physiologic, functional, cognitive, and safety assessments.
• Partner closely with Clinical Development, Clinical Pharmacology, Biostatistics, Data Management, Regulatory, and CMC to support integrated program execution and development decisions.

• Partner with Clinical Development and Clinical Pharmacology to operationalize fit-for-purpose PK and PK/PD strategies, ensuring that sampling, processing, and study procedures preserve the integrity of key pharmacokinetic and pharmacodynamic assessments.
• Ensure study procedures preserve the integrity and quality of decision-critical objective assessments and data.
• Own clinical supply operations, randomization and blinding implementation, investigational product accountability, study‑specific pharmacy procedures, and operational implementation of clinic- and home‑based dosing.
• Develop recruitment and retention strategies appropriate for older adults and participants with early Alzheimer’s disease.
• Lead development and implementation of study plans, vendor specifications, manuals, monitoring approaches, training materials, and fit-for-purpose operational procedures.
• Ensure studies are conducted in accordance with the protocol, GCP, applicable regulatory requirements, and Vesalius quality standards, maintaining inspection‑ready study documentation throughout execution.
• Ensure timely, complete, and inspection‑ready Trial Master File documentation and…