Director, Commercial Compliance

Job Description:

• Lead a risk-based commercial compliance strategy aligned with commercialization priorities and business growth
• Advise senior leaders and cross-functional teams on pharmaceutical promotion, HCP and patient interactions, patient-support programs, Medical Affairs independence, medical information, market access, pricing, government price reporting, and other commercialization risks
• Develop and operationalize compliance policies, procedures, governance, training, certifications, guidance, documentation, and escalation standards for commercial activities
• Establish controls that protect independent decision-making, confidential information, appropriate access, and management of actual or perceived conflicts of interest
• Design and oversee commercial compliance risk assessments, monitoring, testing, investigations support, issue escalation, corrective action, and validation of remediation
• Assess new commercial programs, partnerships, channels, and operating models to identify compliance requirements and address control gaps
• Provide compliance guidance regarding interactions and arrangements with GPOs, distributors, MSOs, specialty pharmacies, provider organizations, and other commercial partners
• Partner with Legal, Regulatory, Medical, Quality, Commercial, Market Access, Technology, Audit, and other control functions to embed clear compliance accountabilities
• Provide concise executive reporting on material risks, compliance readiness, control effectiveness, trends, resource needs, and unresolved issues
• Promote ethical decision-making, speak-up culture, and individual accountability through visible leadership and practical compliance guidance

Requirements:

• Bachelor's degree in business, life sciences, healthcare, public policy, compliance, or a related field
• Advanced degree or relevant compliance certification preferred
• Minimum of 10 years of progressive pharmaceutical, biotechnology, healthcare, or life-sciences compliance experience
• Substantial U.S. commercial compliance responsibility
• Experience developing, implementing, or enhancing a pharmaceutical commercial compliance program across ongoing commercialization activities
• Strong knowledge of U.S. pharmaceutical compliance requirements and industry expectations, including the Anti-Kickback Statute, False Claims Act, FDA promotional requirements, HCP interactions, patient-support programs, Medical Affairs independence, privacy, and transparency obligations
• Experience translating legal and regulatory requirements into practical policies, controls, training, monitoring, investigations support, remediation, and business processes
• Ability to conduct risk assessments, evaluate control effectiveness, identify trends, provide constructive challenge, and escalate material concerns
• Proven ability to lead complex programs and cross-functional initiatives in a matrixed environment and establish clear ownership, documentation, and follow-through
• Strong executive communication, sound judgment, stakeholder leadership, program management, and change-management skills
• Demonstrated discretion in handling privileged, confidential, and commercially sensitive information

Benefits:

• Medical, dental, and vision care
• Backup dependent care
• Adoption assistance
• Infertility coverage
• Family building support
• Behavioral health solutions
• Paid parental leave
• Paid caregiver leave
• Training programs
• Professional development resources
• Mentorship programs
• Employee resource groups
• Volunteer activities