Senior Manager, Pre-Clinical Program and Alliance Management

Responsibilities

• Build and drive integrated cross-functional program plans, timelines, and budgets from candidate selection through IND filing
• Partner with program leadership to define goals, governance cadence, and decision frameworks
• Maintain line of sight to FDA IND data package requirements and track module completion
• Partner with Regulatory Affairs and functional leads to execute IND-enabling activities
• Proactively identify and mitigate program risks and communicate status to senior leadership
• Serve as the day-to-day operational point of contact for external partners, CROs, and collaborators
• Manage governance structures under collaboration, license, and services agreements
• Partner with Business Development, Legal, and Finance to track milestones and deliverables

Requirements

• Bachelor's degree in a relevant scientific discipline (Biology, Biochemistry, Pharmacology, Chemistry)
• 8+ years of biotech or pharmaceutical experience
• 3+ years directly supporting pre-clinical program management and IND-enabling activities
• Demonstrated experience in the successful preparation, filing, and acceptance of INDs
• Working knowledge of FDA IND data package requirements
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project)
• Strong organizational, communication, and interpersonal skills

Preferred Qualifications

• Advanced degree (M.S., Ph.D., Pharm.D.)
• Prior alliance management experience with external collaborators or CROs

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.