Senior Director, Compliance

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

📋 Description

• Act as the primary Compliance business partner for the U.S. Commercial organization, with a focus on Market Access and related activities involving access, reimbursement, and customer interactions.

• Deliver strategic, timely, practical, and risk-based compliance counsel to senior leaders within the Commercial and Market Access sectors.

• Offer advisory services regarding payers, pharmacy benefit managers, group purchasing organizations, health systems, specialty pharmacies, distributors, wholesalers, integrated delivery networks, government accounts, and other stakeholders in market access.

• Provide insights on pricing and contracting, discounts and rebates, formulary discussions, value-based arrangements, patient support and affordability initiatives, reimbursement activities, and other market access projects.

• Assist Sales and Marketing teams with promotional activities, healthcare professional and customer engagements, speaker programs, advisory boards, sponsorships, field activities, and external interactions.

• Implement the North America compliance strategy and consistently improve the risk-based compliance program.

• Recognize emerging compliance risks and propose strategies for mitigation.

• Lead or assist in conducting risk assessments, monitoring, auditing, investigations, and remediation efforts.

• Utilize monitoring results, business data, industry trends, and risk indicators to suggest improvements to controls, training, policies, and processes.

• Aid in compliance governance and reporting to senior leadership.

• Spearhead the development and enhancement of policies, procedures, field guidance, training, and compliance resources.

• Design and implement risk-based compliance training for the Commercial and Market Access teams.

• Convert laws, regulations, enforcement updates, and industry standards into actionable business guidance.

• Foster trusted relationships across Commercial, Market Access, Legal, Corporate Affairs, HR, and other departments.

• Collaborate with the Global Compliance Program Office and regional/global Compliance teams.

• Lead or engage in cross-functional projects, launch readiness initiatives, governance forums, and strategic projects.

• Provide direct leadership, management, coaching, and development to assigned Compliance team members.

• Establish priorities and expectations, offer feedback, and assist direct reports in their professional development and performance.

• Provide functional leadership and mentorship throughout the North America Compliance team.

• Oversee contractors, consultants, or other resources involved in Compliance initiatives.

⛳️ Requirements

• BA/BS Degree is required.

• A minimum of 12 years of relevant experience in healthcare compliance, legal, regulatory, audit, or similar roles within the pharmaceutical, biotechnology, or life sciences sectors.

• Extensive experience supporting U.S. commercial operations.

• Proven experience advising Market Access organizations.

• Deep understanding of the U.S. payer, reimbursement, patient access, trade/distribution, and contracting landscape.

• In-depth knowledge of U.S. pharmaceutical compliance standards and industry regulations, including the Anti-Kickback Statute, False Claims Act, federal and state transparency mandates, FDA promotional requirements, PhRMA Code, and OIG/DOJ compliance expectations.

• Experience providing compliance guidance on payer and customer interactions, discounts and rebates, contracting, formulary discussions, patient support programs, reimbursement assistance, specialty pharmacy, and other access-related activities.

• Background in conducting or supporting risk assessments, monitoring, auditing, training, policy formulation, and remediation.

• Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and collaboration tools such as SharePoint and Teams.

• Willingness to travel domestically approximately 25% of the time.

• An advanced degree (JD, PharmD, MBA, MPH, or similar) is preferred.

• Experience supporting product launches and thriving in a fast-paced, matrixed, and dynamic commercial environment is highly preferred.

• Familiarity with compliance, expense, CRM, analytics, or reporting platforms such as Concur, Salesforce, Power BI, or similar tools is preferred.

🏝️ Benefits

• Eligibility for an annual bonus plan or incentive compensation plan.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance.

• Paid Time Off.

• Wellness benefits.