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).
This leader will 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. This role is a build-and-scale leadership position responsible for designing, embedding, and continuously strengthening a proactive, data-driven, and business-aligned Compliance & Ethics program. You will 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 risks. You will help define "what great looks like" for compliance in a modern biotech and help build the infrastructure to support it.
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):
- 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
Standout Skills for Impact:
- Maintain deep expertise in applicable laws and monitor external compliance developments within the pharmaceutical industry
- Drive innovation in compliance operations through technology, automation, and process improvement
- Champion a culture of transparency, ethical decision-making and accountability across Commercial, as well as other key external-facing business areas
- Together with other Compliance & Ethics team members, lead the development of role-specific, risk-based training and awareness programs that drive behavior change
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%