Clinical Operations Senior Manager

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.

This is an exciting time to join Kiniksa as the company continues on a strong growth trajectory. You will join a dynamic Clinical Operations team working in a fast-paced, highly collaborative environment, with the opportunity to help shape how we deliver high-quality clinical programs and contribute to the future success of the organization.

The Senior Manager, Clinical Operations provides / supports the operational leadership and strategic oversight of the planning, conduct, and delivery of global clinical trials. This role partners cross-functionally and with external service providers to ensure studies are executed in accordance with quality, timeline, budget, and regulatory expectations .

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities ( including, but not limited to ):

• Provide operational oversight and leadership for assigned clinical development activities.
• Partner with cross-functional stakeholders to support effective study planning, execution, and decision-making.
• Drive proactive identification, assessment, and escalation of 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 implementation of protocol amendments, study changes, and operational processes 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.

Standout Skills:

• Strong knowledge of ICH-GCP and international clinical trial regulations.
• Understanding of clinical trial planning, execution, risk management, and vendor oversight.
• Ability to operate well in complex matrix environment and vendor setup and 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.

Qualifications and Experience:

• Bachelor's degree in a scientific, healthcare, or related field required.
• Advanced degree preferred.
• 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.
• Proficient with Microsoft Office and clinical systems (eTMF, CTMS, IRT, EDC).

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range

$170,000 — $190,000 USD

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.