Director, Clinical Operations – Ophthalmology Trials

Alkeus Pharmaceuticals, Inc.; Cambridge (MA); On-site; USD 190,000 - 220,000; Full time

Benefits offered by this job

Discretionary bonus up to 20%

Medical/dental/vision insurance

401(K) plan

Flexible time off

Job summary

Alkeus Pharmaceuticals, Inc. in Cambridge, MA, seeks a Director of Clinical Operations to lead global late-stage pivotal trials in alignment with regulatory standards.

You will oversee CROs, vendors, site activation, and study execution across all phases to ensure timely delivery and data quality. The role requires 10+ years in clinical trial management (7+ in global operations), experience with ophthalmology or rare diseases, and strong leadership, communication, and cross-functional

Qualifications

• BA/BS degree required; advanced degree preferred.
• 10+ years in clinical trial management with 7+ years in global late-stage ops.
• Experience with CRO/vendor selection and management.
• Background in rare diseases and ophthalmology a plus.
• Strong knowledge of GXP, ICH/GCP and global regulations.
• Excellent communication and leadership abilities.

Responsibilities

• Lead day-to-day clinical trial operations for global pivotal trials.
• Oversee CROs and vendors to meet timelines and budgets.
• Develop study plans and risk dashboards.
• Ensure quality and regulatory compliance and audit readiness.
• Coordinate cross-functional teams across phases.
• Monitor site activation and enrollment performance.
• Drive continuous improvement and TMF/documentation.

Skills

Leadership

Strategic planning

Cross-functional collaboration

Communication

Clinical operations

Education

BA/BS degree in related field

Job description

Alkeus Pharmaceuticals, Inc. in Cambridge, MA, seeks a Director of Clinical Operations to lead global late-stage pivotal trials in alignment with regulatory standards.

You will oversee CROs, vendors, site activation, and study execution across all phases to ensure timely delivery and data quality. The role requires 10+ years in clinical trial management (7+ in global operations), experience with ophthalmology or rare diseases, and strong leadership, communication, and cross-functional