Director, Commercial Compliance

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Spearhead a risk-driven commercial compliance strategy that aligns with commercialization goals and fosters business expansion.

• Provide guidance to senior leaders and cross-functional teams on pharmaceutical promotions, healthcare professional and patient interactions, patient-support initiatives, Medical Affairs independence, medical information, market access, pricing, government price reporting, and various commercialization risks.

• Create and implement compliance policies, procedures, governance frameworks, training programs, certifications, guidelines, documentation, and escalation standards for commercial operations.

• Establish controls that safeguard independent decision-making, confidentiality, appropriate access, and the management of actual or perceived conflicts of interest.

• Design and oversee commercial compliance risk assessments, monitoring, testing, support for investigations, issue escalation, corrective actions, and validation of remediation efforts.

• Evaluate new commercial programs, partnerships, channels, and operating models to identify compliance obligations and address control deficiencies.

• Offer compliance guidance concerning interactions and agreements with GPOs, distributors, MSOs, specialty pharmacies, provider organizations, and other commercial partners.

• Collaborate with Legal, Regulatory, Medical, Quality, Commercial, Market Access, Technology, Audit, and other control functions to instill clear compliance responsibilities.

• Deliver succinct executive reports on significant risks, compliance readiness, control effectiveness, emerging trends, resource requirements, and unresolved issues.

• Champion ethical decision-making, foster a speak-up culture, and promote individual accountability through visible leadership and practical compliance support.

⛳️ Requirements

• Bachelor’s degree in business, life sciences, healthcare, public policy, compliance, or a related discipline.

• An advanced degree or relevant compliance certification is preferred.

• At least 10 years of progressive experience in pharmaceutical, biotechnology, healthcare, or life-sciences compliance.

• Significant U.S. commercial compliance responsibilities.

• Experience in developing, implementing, or enhancing a pharmaceutical commercial compliance program across ongoing commercialization efforts.

• Strong understanding of U.S. pharmaceutical compliance requirements and industry standards, including the Anti-Kickback Statute, False Claims Act, FDA promotional guidelines, healthcare professional interactions, patient-support programs, Medical Affairs independence, privacy, and transparency obligations.

• Experience in translating legal and regulatory requirements into effective policies, controls, training, monitoring, investigative support, remediation, and business processes.

• Ability to conduct risk assessments, evaluate control effectiveness, identify trends, provide constructive feedback, and escalate significant concerns.

• Proven track record in leading complex programs and cross-functional initiatives within a matrixed environment, establishing clear ownership, documentation, and follow-through.

• Excellent executive communication skills, sound judgment, stakeholder leadership, program management, and change management capabilities.

• Demonstrated discretion in managing 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.