Clinical Operations Senior Manager
Kiniksa Pharmaceuticals
Kiniksa Pharmaceuticals seeks a Clinical Operations Senior Manager to provide operational leadership and strategic oversight of global clinical trial planning, conduct, and delivery. The role partners across functions and with external vendors to ensure studies meet quality, timeline, budget, and regulatory standards.
Responsibilities
- Provide operational oversight and 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 vendors to ensure quality delivery and performance against study objectives
- Ensure implementation of protocol amendments and operational processes in alignment with program objectives
Requirements
- Bachelor's degree in scientific, healthcare, or related field
- 7+ years of clinical operations experience in biotech, pharma, or CRO
- Strong knowledge of ICH-GCP and international clinical trial regulations
- Experience supporting and leading global Phase 1, 2, and/or 3 trials
- Demonstrated experience managing CROs and external vendors
- Ability to operate in complex matrix environments and lead without authority
- Technical understanding of clinical trial systems and integrations
Vacancy posted 2 days ago
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