Director Commercial Compliance
About The Position
The Director, Commercial Compliance serves as the primary Compliance partner for U.S. pharmaceutical and biosimilar commercialization. This role leads development and oversight of a risk-based compliance framework, advises senior leaders, and provides independent challenge on higher-risk business decisions. The Director supports compliant execution and continued evolution of the commercialization model while coordinating appropriately with third parties responsible for product development and other external capabilities. The position is based in the USA and is remote. It is responsible for building commercial compliance strategy and governance, advising on commercialization risks, establishing controls, overseeing risk assessments and monitoring, and providing executive reporting. The Director also promotes ethical decision-making, a speak-up culture, and individual accountability. Cencora describes its offerings as including medical, dental, and vision care; support for working families that may include backup dependent care, adoption assistance, infertility coverage, family-building support, behavioral health solutions, paid parental leave, and paid caregiver leave; and training, professional development, mentorship, employee resource groups, and volunteer activities.
Requirements
- Bachelor's degree in business, life sciences, healthcare, public policy, compliance, or a related field.
- Minimum of 10 years of progressive pharmaceutical, biotechnology, healthcare, or life-sciences compliance experience, including substantial U.S. commercial compliance responsibility.
- Demonstrated 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.
Nice To Haves
- Advanced degree or relevant compliance certification.
- Experience in biosimilars, specialty pharmaceuticals, ophthalmology, oncology, or other complex therapies.
- Commercial compliance experience involving GPOs, distributors, specialty pharmacies, provider organizations, or other healthcare intermediaries and commercial partners.
- Experience evaluating compliance risks arising from third-party commercialization arrangements, affiliated entities, joint ventures, or complex operating models.
- Experience with information barriers, promotional review, preapproval information exchange, compliance analytics, investigations, auditing, or data-informed monitoring.
Responsibilities
- 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.
Benefits
- Medical, dental, and vision care.
- Backup dependent care may be available.
- Adoption assistance.
- Infertility coverage and family-building support.
- Behavioral health solutions.
- Paid parental leave.
- Paid caregiver leave.
- Training programs and professional development resources.
- Mentorship programs.
- Employee resource groups.
- Volunteer activities.
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What This Job Offers
Job Type
Full-time
Career Level
Director
