Senior Director, Healthcare Compliance

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