Senior Clinical Operations Lead, Global Trials

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

Job summary

Kiniksa Pharmaceuticals, Ltd. is seeking a Senior Manager, Clinical Operations to provide operational leadership for global clinical trials. The role partners with cross-functional teams and external vendors to ensure studies meet quality, timeline, budget, and regulatory expectations.

The position is based in Lexington, MA and requires onsite presence five days a week. Responsibilities include overseeing study planning, risk management, vendor oversight, operational plans, and continuous

Qualifications

• Bachelor's degree required for scientific/healthcare field.
• Advanced degree preferred.
• 7+ years of clinical operations experience in biotech/pharma/CRO.
• Experience managing CROs and external vendors.
• Experience in global Phase 1–3 trials and cross-functional teams.
• Proficient with Microsoft Office and clinical systems (eTMF, CTMS, IRT, EDC).

Responsibilities

• Provide operational leadership for assigned clinical development activities.
• Partner with cross-functional stakeholders for study planning and execution.
• Identify and escalate operational risks and issues.
• Oversee vendors to ensure quality and performance.
• Maintain study operational plans and related deliverables.
• Implement protocol amendments and study changes.
• Maintain inspection readiness and regulatory compliance.
• Communicate study status and metrics to stakeholders.
• Contribute to continuous improvement in trial execution.

Skills

ICH-GCP knowledge

Vendor oversight

Cross-functional collaboration

Stakeholder management

Education

Bachelor's degree in science/healthcare

Advanced degree preferred

Tools

eTMF

CTMS

IRT

EDC

Job description

Kiniksa Pharmaceuticals, Ltd. is seeking a Senior Manager, Clinical Operations to provide operational leadership for global clinical trials. The role partners with cross-functional teams and external vendors to ensure studies meet quality, timeline, budget, and regulatory expectations.

The position is based in Lexington, MA and requires onsite presence five days a week. Responsibilities include overseeing study planning, risk management, vendor oversight, operational plans, and continuous