Global Clinical Operations Senior Manager

Kiniksa Pharmaceuticals, Ltd.; Lexington (MA); On-site; USD 170,000 - 190,000; Full time

Job summary

Kiniksa Pharmaceuticals, Ltd. is seeking a Senior Manager, Clinical Operations to lead global clinical development activities from our Lexington, MA office.

This onsite role partners with cross-functional teams and external vendors to ensure trials are delivered on time, within budget, and in compliance with quality standards. With 7+ years in clinical operations, you will drive study plans, risk management, and vendor oversight across Phase 1–3 programs, contributing to our mission to advance

Qualifications

• Bachelor's degree in scientific, healthcare, or related field required.
• Advanced degree preferred.
• 7+ years of clinical operations experience in biopharma/CRO.
• Experience supporting global Phase 1–3 trials and managing CROs.

Responsibilities

• Provide operational leadership for global clinical development activities.
• Partner with cross-functional stakeholders for study planning and execution.
• Drive proactive identification and escalation of operational risks and issues.
• Oversee CROs and external vendors for quality delivery.
• Support development and execution of study operational plans and deliverables.
• Ensure protocol amendments and changes align with objectives.
• Maintain inspection readiness and regulatory compliance (GCP).
• Communicate study status and metrics to stakeholders.

Skills

ICH-GCP knowledge

Clinical operations

Vendor oversight

Cross-functional collaboration

Stakeholder management

Problem-solving

Clinical systems

MS Office

Education

Bachelor's degree in science/healthcare

Advanced degree preferred

Tools

MS Office

eTMF/CTMS/IRT/EDC

Job description

Kiniksa Pharmaceuticals, Ltd. is seeking a Senior Manager, Clinical Operations to lead global clinical development activities from our Lexington, MA office.

This onsite role partners with cross-functional teams and external vendors to ensure trials are delivered on time, within budget, and in compliance with quality standards. With 7+ years in clinical operations, you will drive study plans, risk management, and vendor oversight across Phase 1–3 programs, contributing to our mission to advance