Director, Clinical Operations — Ophthalmology Trials Leader

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

Job summary

Alkeus Pharmaceuticals, Inc. is seeking a Director of Clinical Operations to lead global, late-stage pivotal trials in alignment with regulatory standards and corporate objectives.

You will oversee CROs and vendors to ensure on-time delivery within budget, managing site activation, enrollment, monitoring, and study closeout across all phases. The role requires 10+ years in clinical trial management (7+ in global late-stage trials), strong GXP/ICH/GCP expertise, and experience with ophthalmology

Qualifications

• BA/BS degree with 10+ years of clinical trial management experience or advanced degree in a related field with at least 7+ years of clinical trial management experience.
• Minimum of 10 years of progressive experience in clinical research and drug development including 7+ years in global, late-stage trials.
• Experience with CRO/vendor selection and management.
• Strong command of GXP requirements and ICH/GCP guidelines and global clinical trial regulations.
• Experience in rare disease and/or ophthalmology drugs is a plus.

Responsibilities

• Manage day-to-day clinical trial operations and execution of assigned studies with cross-functional teams to inform broader clinical development strategy.
• Provide end-to-end oversight of pivotal trials through initiation, enrollment, monitoring, and closeout.
• Develop and maintain project plans and dashboards to proactively manage risk and ensure targets are met.
• Ensure all trial activities comply with global regulatory and ethical standards (GCP, ICH).
• Monitor vendor activities against contracts and escalate issues to maintain quality and timeline commitments.
• Act as primary operational contact across internal teams to drive alignment and cohesive study execution.
• Oversee site identification and activation with CRO and clinical team, monitoring site performance for enrollment and data quality.
• Resolve site-level issues, identify root causes, and implement corrective actions to minimize disruptions.

Skills

Leadership

Cross-functional

Project management

Strategic planning

Education

BA/BS in life sciences or related field

Advanced degree (MS/PhD/PharmD)

Job description

Alkeus Pharmaceuticals, Inc. is seeking a Director of Clinical Operations to lead global, late-stage pivotal trials in alignment with regulatory standards and corporate objectives.

You will oversee CROs and vendors to ensure on-time delivery within budget, managing site activation, enrollment, monitoring, and study closeout across all phases. The role requires 10+ years in clinical trial management (7+ in global late-stage trials), strong GXP/ICH/GCP expertise, and experience with ophthalmology