Director Commercial Compliance

Cencora•USA > PA > Remote, PA

10d•$119,100 - $186,560•Remote

About The Position

The Director, Commercial Compliance serves as the primary Compliance partner for U.S. pharmaceutical and biosimilar commercialization. The role leads the development and oversight of a risk-based compliance framework for commercialization, advises senior leaders, and provides independent challenge on higher-risk business decisions. The Director supports the compliant execution and continued evolution of the commercialization model while coordinating appropriately with third parties responsible for product development and other external capabilities.

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, 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

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.
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.