Head of Early Clinical Operations - Neuro

Flagship Pioneering, Inc.; Cambridge (MA); On-site; USD 183,000 - 231,000; Full time

Job summary

Vesalius Therapeutics is seeking an experienced Director of Clinical Operations to lead the operational execution of an early-stage Alzheimer's program, translating clinical strategy into high-quality, efficiently executed studies and partnering with cross-functional leaders across Clinical Development, Pharmacology, Biostatistics, Data Management, Regulatory, and CMC.

The candidate will own the program from protocol development through startup, enrollment, execution, database lock, and

Qualifications

• Experience in Alzheimer’s disease, mild cognitive impairment (MCI), neurodegenerative disease, or adjacent CNS/neurology indications.
• Early-stage CNS clinical development experience.
• Experience with clinical pharmacology and PK/PD studies.
• Experience with biomarker-intensive clinical trials and objective or technology-enabled clinical assessments.
• Familiarity with population PK, exposure-response, or model-informed drug development.
• Experience conducting studies involving older adults or cognitively impaired participants.
• Experience supporting IND/CTA preparation and interactions with FDA, MHRA, or other major regulatory authorities.

Responsibilities

• 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.
• Establish and manage CROs, clinical research units, central and bioanalytical laboratories, biomarker vendors, technology partners, and other specialty service providers, with clear accountability for quality, timelines, and performance.
• Lead vendor selection and operational contracting in partnership with Finance and Legal, and maintain accountability for study budgets, forecasts, change orders, timelines, and vendor performance.
• Maintain clear visibility of critical path, enrollment, cost, data quality, vendor performance, and operational risks, and communicate status and recommendations clearly to senior leadership.
• Build scalable clinical operations processes and infrastructure capable of supporting rapid progression from early clinical development into subsequent proof-of-concept studies.
• Provide leadership, mentorship, and oversight to internal and external Clinical Operations resources as the program and organization grow.

Skills

Alzheimer's experience

CNS clinical development

Clinical pharmacology

PK/PD studies

Biomarkers

Vendor management

Regulatory interactions

Cross-functional leadership

Job description

Vesalius Therapeutics is seeking an experienced Director of Clinical Operations to lead the operational execution of an early-stage Alzheimer's program, translating clinical strategy into high-quality, efficiently executed studies and partnering with cross-functional leaders across Clinical Development, Pharmacology, Biostatistics, Data Management, Regulatory, and CMC.

The candidate will own the program from protocol development through startup, enrollment, execution, database lock, and