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).