Senior Director, Healthcare Compliance

Overview

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 role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Senior Director, Healthcare Compliance, reporting to the VP, Head of Compliance, will serve as the primary Compliance & Ethics business partner to the Commercial organization and key external‑facing functions (Medical Affairs, Patient Services, and Patient Advocacy).

• Shape and drive the framework for compliance and ethical conduct within the Commercial organization and other key functions to enable responsible growth as the company evolves from a single‑product to a multi‑asset commercial organization.
• Design, embed, and continuously strengthen a proactive, data‑driven, and business‑aligned Compliance & Ethics program.
• Operate as a trusted partner to business area leadership to ensure business strategy aligns with laws, regulations, and Kiniksa policies; proactively identify and mitigate risk.
• Define “what great looks like” for compliance in a modern biotech and build the infrastructure to support it.
• Lead the development and execution of scalable compliance processes and procedures to support future product launches and geographic expansion.

• Strategic Leadership & Ownership
• Define and lead the Compliance & Ethics strategy for the Commercial organization and other key business areas, aligning priorities with growth, product lifecycle, and market expansion.
• Serve as the accountable Compliance & Ethics partner for Commercial, Medical Affairs, Patient Services, and Patient Advocacy.
• Represent Compliance & Ethics in cross‑functional leadership discussions, embedding compliance into business planning.
• Design and help build scalable compliance processes and procedures to support future product launches and geographic expansion.

• Proactively identify, assess, and advise on mitigation of compliance risks across external‑facing business activities; provide clear, actionable guidance on complex topics including:
• Engagements with Healthcare Professionals (HCPs);
  Sponsor ships, grants, and charitable contributions;
  Patient support programs;
  Patient advocacy group interactions;
  Market access and emerging commercialization models.
• Partner with Commercial leadership to design processes and procedures that enable compliance.

• Oversee the development, implementation, and effectiveness of Compliance & Ethics policies, standards, and governance for Commercial and other external‑facing business areas.
• Provide input into the development and implementation of a risk‑based monitoring and auditing program, leveraging data and analytics.
• Ensure healthcare compliance requirements are addressed in other program activities, including but not limited to risk assessments, third‑party due diligence, fair market value and tiering of HCPs, and needs assessments.
• Drive innovation in compliance operations through technology, automation, and process…