Director, Clinical Operations — Early CNS Trials

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

Job summary

Vesalius Therapeutics is seeking an experienced, hands-on Director of Clinical Operations to lead an early-stage Alzheimer’s disease program. This role will translate scientific objectives into operational, data-driven studies and partner with cross-functional teams to ensure high-quality execution across PK/PD, biomarkers, and functional assessments.

The ideal candidate will own study start‑up to close‑out, manage CROs and vendors, and develop recruitment strategies for older adults with

Qualifications

• Experience in Alzheimer’s disease, mild cognitive impairment (MCI), neurodegenerative disease, or adjacent CNS/neurology indications.
• 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.
• Partner with Clinical Development and Clinical Pharmacology to operationalize fit-for-purpose PK and PK/PD strategies, ensuring integrity of PK/PD assessments.
• 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, regulatory requirements, and quality standards; maintain inspection‑ready documentation.
• Establish and manage CROs, clinical research units, laboratories, biomarker vendors, and other service providers with accountability for quality and timelines.
• Lead vendor selection and operational contracting and manage budgets, forecasts, and change orders.

Skills

Experience in Alzheimer’s disease

Clinical pharmacology

Biomarker‑intensive trials

PK/PD studies

Older adults studies

IND/CTA regulatory interactions

Job description

Vesalius Therapeutics is seeking an experienced, hands-on Director of Clinical Operations to lead an early-stage Alzheimer’s disease program. This role will translate scientific objectives into operational, data-driven studies and partner with cross-functional teams to ensure high-quality execution across PK/PD, biomarkers, and functional assessments.

The ideal candidate will own study start‑up to close‑out, manage CROs and vendors, and develop recruitment strategies for older adults with