Senior Director, Healthcare Compliance

Responsibilities

• Define and lead the Compliance & Ethics strategy for the Commercial organization and other key business areas
• Serve as the primary Compliance & Ethics business partner for Commercial, Medical Affairs, Patient Services, and Patient Advocacy
• Design and 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 guidance on complex topics including HCP engagements, sponsorships, grants, and patient support programs
• Oversee the development and implementation of Compliance & Ethics policies, standards, and governance
• Provide input into risk-based monitoring and auditing programs leveraging data and analytics
• Ensure compliance requirements are addressed in risk assessments, third-party due diligence, and fair market value assessments

Requirements

• 10+ years in pharmaceutical/biotech compliance
• Experience advising or serving as a compliance business partner to Commercial organizations (Sales, Marketing, etc.)
• Strong knowledge of U.S. Anti-Kickback Statute, U.S. False Claims Act, PhRMA Code, and OIG guidance
• Experience providing compliance guidance regarding HCP engagements, grants, and patient support programs
• Proven track record of building or scaling compliance and ethics programs
• B.A./B.S. degree required
• Willingness to travel up to 25%

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.