Associate Director, Pre-Clinical Program & Alliance Management

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.

Kiniksa is seeking a highly organized and execution-oriented Associate Director / Director, Pre-Clinical Program and Alliance Management to drive the operational planning, integration, and delivery of pre-clinical programs from candidate nomination through successful IND filing and acceptance. The role reports to the Group Vice President, Chief Business Officer. 

This individual will serve as the central operational hub for one or more pre-clinical assets, coordinating cross-functional activities across research, CMC, nonclinical safety/toxicology, translational, regulatory, and program leadership, while also managing day-to-day interactions with external partners, CROs, and collaborators. The Associate Director / Director will be accountable for building and maintaining integrated program plans, anticipating critical path risks, and ensuring alignment of internal stakeholders and external alliance partners against shared IND-enabling milestones 

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):  

Pre-Clinical Program Management & IND Enablement 

• Build and drive integrated cross-functional program plans, timelines, and budgets from candidate selection through IND filing and acceptance, with clear critical path, dependencies, and decision points across CMC, nonclinical safety/toxicology, translational, and regulatory workstreams.
• Partner with program leadership to define goals, governance cadence, and decision frameworks; run core team and governance meetings and ensure timely follow-through on actions.
• Maintain line of sight to FDA IND data package requirements; track module completion and ensure cross-functional alignment on content, quality, and timing.
• Partner with Regulatory Affairs and functional leads to execute IND-enabling activities (GLP toxicology, safety pharmacology, CMC, analytical methods, translational readiness) and to prepare for and follow up from FDA interactions (e.g., pre-IND, Type B/C meetings).