Senior Director, Healthcare Compliance

Responsibilities

• 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, and needs assessments
• Act as a visible and trusted compliance leader, fostering a “speak-up” culture.
• 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

Qualifications and Experience

• 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%