Sr. Director, Healthcare Compliance

Kiniksa Pharmaceuticals•Lexington, MA

64d•$250,000 - $280,000•Onsite

About The Position

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. We are seeking a strategic, enterprise-minded Senior Director, Healthcare Compliance reporting to VP, Head of Compliance to serve as the primary Compliance & Ethics business partner to our Commercial organization and key external-facing functions (Medical Affairs, Patient Services, and Patient Advocacy).

Requirements

10+ years in pharmaceutical/biotech compliance
Experience advising or serving as a compliance business partner to the Commercial organization (e.g., Sales, Marketing, Thought Leader Liaisons).
Strong knowledge of U.S. Anti-Kickback Statute, U.S. False Claims Act, PhRMA Code, OIG guidance, and applicable state regulations.
Experience providing compliance guidance regarding HCP engagements, grants, sponsorships, and patient support programs.
Track record of successfully building or scaling compliance and ethics programs
Excellent communication and prioritization skills, with an ability to work in a collaborative, cross-functional environment.
B.A./B.S. degree required
Willingness to travel up to 25%

Responsibilities

Shape and drive the framework for compliance and ethical conduct within the Commercial organization and other key functions, enabling responsible growth as we evolve from a single-product company into 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, ensuring that business strategy aligns to laws, regulations, and Kiniksa polices, and proactively identifying and mitigating risk.
Help define “what great looks like” for compliance in a modern biotech and help build the infrastructure to support it.
Define and lead the Compliance & Ethics strategy for the Commercial organization, as well as other key business areas, aligning compliance priorities with Company growth, product lifecycle, and market expansion.
Serve as the accountable Compliance & Ethics business partner for Commercial, as well as Medical Affairs, Patient Services, and Patient Advocacy.
Represent Compliance & Ethics in cross-functional leadership discussions, proactively 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), Sponsorships, 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, as well as 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, Needs assessments.
Drive innovation in compliance operations through technology, automation, and process improvement.
Lead the development of role-specific, risk-based training and awareness programs that go beyond check-the-box and drive behavior change.
Champion a culture of transparency, ethical decision-making and accountability across Commercial, as well as other key external-facing business areas.
Act as a visible and trusted compliance leader, fostering a “speak-up” culture.
Maintain deep expertise in applicable laws and monitor external compliance developments within the pharmaceutical industry.
Proactively assess the potential impact of regulatory changes or compliance developments on Kiniksa’s business model.
Provide guidance on key regulations, standards, and industry codes, including but not limited to: Anti-kickback laws, False Claims Act, Fraud & abuse laws, U.S. Department of Justice (DOJ) and U.S. Health & Human Services Office of Inspector General (OIG) Compliance Program Guidance, PhRMA Code.