Clinical Operations Senior Manager

Regulatory Toolkit; Lexington (MA); On-site; USD 170,000 - 190,000; Full time

Job summary

Kiniksa Pharmaceuticals in Lexington, MA seeks a Senior Manager, Clinical Operations to provide operational leadership for global trials and partner with vendors to ensure quality, timelines, and regulatory compliance. This onsite role collaborates with cross-functional teams to plan studies, manage risks, and drive continuous improvement in trial execution while maintaining inspection readiness.

Join a patient‑first culture leveraging immunology and inflammation expertise to deliver therapies

Qualifications

• Bachelor's degree in a scientific, healthcare, or related field.
• Advanced degree preferred for leadership roles.
• 7+ years of clinical operations experience in biotech/pharma/CRO environments.

Responsibilities

• Provide operational leadership for assigned clinical development activities.
• Partner with cross-functional stakeholders to support study planning, execution, and decision-making.
• Drive proactive identification, assessment, and escalation of operational risks and issues.
• Oversee CROs and vendors to ensure quality delivery and performance.
• Support development, maintenance, and execution of study operational plans and deliverables.
• Ensure protocol amendments and study changes are implemented in line with objectives.
• Maintain inspection readiness and regulatory compliance (GCP, regulations).
• Communicate study status, risks, and metrics to stakeholders and senior management.
• Contribute to continuous improvement initiatives in trial execution.

Skills

ICH-GCP knowledge

Clinical trial planning

Risk management

Vendor oversight

Stakeholder management

Cross-functional collaboration

Decision making

Education

Bachelor's degree in science/healthcare

Advanced degree preferred

Tools

Microsoft Office

eTMF

CTMS

IRT

EDC

Job description

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 is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities areprovidedreasonable accommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.