Director, Clinical Operations at Flagship Pioneering in Cambridge, MA USA

Job description

• 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 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 workstreams into a disciplined clinical program.
• The successful candidate will build and lead the operational capability required to execute the program’s early clinical studies on time, on budget, and to a high standard. They will drive disciplined study start-up and execution, effective CRO/site/vendor performance, strong enrollment and retention, robust clinical supply and study logistics, proactive risk management, inspection-ready documentation, and delivery of complete, high-quality data to support timely program decisions and progression through key clinical milestones.

Responsibilities

• Clinical Program Ownership
• 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.
• Clinical Trial Execution
• 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 appropriate oversight of CRO-maintained study records.
• Support IND/CTA preparation and regulatory authority interactions as appropriate.
• CRO, Site & Vendor Management
• 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.
• Organizational Contribution
• 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.

Requirements

• 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.
• Demonstrates strong sponsor ownership and accountability rather than relying solely on CRO-led execution.
• Comfortable moving between strategic program questions and detailed study execution.
• Balances scientific rigor with pragmatic, fit-for-purpose operational execution.
• Anticipates execution risks before they affect enrollment, timelines, cost, or data quality.
• Works effectively across clinical, scientific, regulatory, biometrics, and CMC functions.
• Communicates clearly and concisely with senior leadership and cross-functional partners.
• Thrives in an environment where speed, scientific rigor, collaboration, and pragmatic decision-making are equally important.

Skills

Required

• Clinical pharmacology
• PK/PD studies
• Biomarker-intensive clinical trials
• Population PK
• Exposure-response
• Model-informed drug development
• GCP
• Trial Master File
• CRO management
• Vendor management
• Regulatory interactions (FDA, MHRA)

Benefits

• The salary range for this role is $183,000 - $231,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Vesalius Therapeutics currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Vesalius Therapeutics's good faith estimate as of the date of publication and may be modified in the future.