Senior Director, Healthcare Compliance
Kiniksa Pharmaceuticals
July 01, 2026
On-site
Lexington, MA
Corporate Functions
Responsibilities:
- Define and lead the Compliance & Ethics strategy for Commercial and other key business areas, aligning priorities with growth, product lifecycle, and market expansion.
- Serve as the accountable Compliance & Ethics business partner for Commercial, Medical Affairs, Patient Services, and Patient Advocacy.
- Represent Compliance in cross-functional leadership discussions and embed compliance into business planning.
- Design and build scalable compliance processes to support product launches and geographic expansion.
- Identify, assess, and advise on mitigation of compliance risks across external-facing activities.
- Provide actionable guidance on HCP engagements, sponsorships, grants/charitable contributions, patient support programs, patient advocacy group interactions, market access, and emerging commercialization models.
- Partner with Commercial leadership to enable compliance through processes and procedures.
- Oversee development, implementation, and effectiveness of Compliance & Ethics policies, standards, and governance.
- Provide input into risk-based monitoring and auditing using data/analytics.
- Ensure compliance requirements are addressed across program activities (risk assessments, third-party due diligence, fair market value, HCP tiering, needs assessments).
- Foster a “speak-up” culture.
- Provide guidance on key regulations/standards and industry codes (Anti-kickback laws, False Claims Act, Fraud/abuse laws, DOJ/OIG guidance, PhRMA Code).
Qualifications & Experience:
- 10+ years in pharmaceutical/biotech compliance.
- Experience as a compliance business partner to Commercial (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 advising on HCP engagements, grants, sponsorships, and patient support programs.
- Track record building/scaling compliance and ethics programs.
- Excellent communication and prioritization; collaborative, cross-functional.
- B.A./B.S. degree required.
- Travel up to 25%.
Skills:
- Maintain deep expertise in applicable laws and monitor industry compliance developments.
- Drive compliance operations innovation via technology, automation, and process improvement.
- Champion transparency, ethical decision-making, and accountability.
- Lead role-specific, risk-based training and awareness programs.
Pay Range:
- $250,000 - $280,000 USD
- Define and lead the Compliance & Ethics strategy for Commercial and other key business areas, aligning priorities with growth, product lifecycle, and market expansion.
- Serve as the accountable Compliance & Ethics business partner for Commercial, Medical Affairs, Patient Services, and Patient Advocacy.
- Represent Compliance in cross-functional leadership discussions and embed compliance into business planning.
- Design and build scalable compliance processes to support product launches and geographic expansion.
- Identify, assess, and advise on mitigation of compliance risks across external-facing activities.
- Provide actionable guidance on HCP engagements, sponsorships, grants/charitable contributions, patient support programs, patient advocacy group interactions, market access, and emerging commercialization models.
- Partner with Commercial leadership to enable compliance through processes and procedures.
- Oversee development, implementation, and effectiveness of Compliance & Ethics policies, standards, and governance.
- Provide input into risk-based monitoring and auditing using data/analytics.
- Ensure compliance requirements are addressed across program activities (risk assessments, third-party due diligence, fair market value, HCP tiering, needs assessments).
- Foster a “speak-up” culture.
- Provide guidance on key regulations/standards and industry codes (Anti-kickback laws, False Claims Act, Fraud/abuse laws, DOJ/OIG guidance, PhRMA Code).
Qualifications & Experience:
- 10+ years in pharmaceutical/biotech compliance.
- Experience as a compliance business partner to Commercial (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 advising on HCP engagements, grants, sponsorships, and patient support programs.
- Track record building/scaling compliance and ethics programs.
- Excellent communication and prioritization; collaborative, cross-functional.
- B.A./B.S. degree required.
- Travel up to 25%.
Skills:
- Maintain deep expertise in applicable laws and monitor industry compliance developments.
- Drive compliance operations innovation via technology, automation, and process improvement.
- Champion transparency, ethical decision-making, and accountability.
- Lead role-specific, risk-based training and awareness programs.
Pay Range:
- $250,000 - $280,000 USD