Clinical Operations Senior Manager

Kiniksa Pharmaceuticals • Lexington, MA

1d • Onsite

About The Position

The Senior Manager, Clinical Operations provides operational leadership and strategic oversight for the planning, conduct, and delivery of global clinical trials. The role partners with cross-functional stakeholders and external service providers to ensure studies meet quality, timeline, budget, and regulatory expectations. It is based in Kiniksa’s Lexington, Massachusetts office and requires onsite work five days per week.

The position contributes to clinical development activities in a fast-paced, collaborative environment, supporting effective study planning, execution, and decision-making. It also helps maintain inspection readiness, communicate study status and risks, and improve clinical trial execution and operational effectiveness.

Requirements

• Bachelor’s degree in a scientific, healthcare, or related field.
• At least 7 years of clinical operations experience within a biotechnology, pharmaceutical, or CRO environment.
• Experience supporting and/or leading global Phase 1, 2, and/or 3 clinical trials.
• Demonstrated experience managing CROs and external vendors.
• Experience working within cross-functional clinical development teams.
• Proficiency with Microsoft Office and clinical systems, including eTMF, CTMS, IRT, and EDC.
• Strong knowledge of ICH-GCP and international clinical trial regulations.
• Understanding of clinical trial planning, execution, risk management, and vendor oversight.
• Ability to work effectively in a complex matrix environment and vendor setup, and to lead without authority.
• Strong organizational, communication, and stakeholder management skills.
• Ability to manage multiple priorities in a dynamic and ambiguous environment.
• Demonstrated problem-solving and decision-making abilities.
• Technical understanding of clinical trial systems and integrations.

Nice To Haves

• Advanced degree.

Responsibilities

• Provide operational oversight and leadership for assigned clinical development activities.
• Partner with cross-functional stakeholders to support effective study planning, execution, and decision-making.
• Proactively identify, assess, and escalate operational risks and issues.
• Oversee vendors to ensure quality delivery and performance against study objectives.
• Support development, maintenance, and execution of study operational plans and associated deliverables.
• Ensure protocol amendments, study changes, and operational processes are implemented in alignment with program objectives.
• Maintain inspection readiness and support compliance with GCP, regulatory requirements, and company procedures.
• Communicate study and program status, risks, and key metrics to stakeholders and senior management.
• Contribute to continuous improvement initiatives that enhance clinical trial execution and operational effectiveness.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior