Senior Director, Compliance

About the role

We are seeking an experienced and strategic Senior Director, Compliance to be an integral part of the team responsible for building, implementing, and leading the company’s compliance program as we transition from a clinical-stage biotechnology company to a commercial organization preparing for the launch of our first product.

Responsibilities

• Partner with the General Counsel & Chief Compliance Officer to develop the company’s compliance strategy and operating model.
• Aid in the design and implementation of a comprehensive healthcare compliance program supporting commercial launch readiness.
• Establish compliance policies, procedures, governance structures, and reporting frameworks.
• Create investigation, escalation, corrective action, and issue-management processes.
• Build compliance committee structures and reporting processes for executive leadership.
• Advise cross-functional leaders on healthcare compliance risks and requirements.
• Support commercialization activities, including promotional review, speaker programs, patient support programs, field force interactions, grants, and third-party engagements.
• Provide practical, business-oriented guidance that enables responsible growth while maintaining regulatory compliance.
• Develop and implement enterprise-wide compliance training and communication programs.
• Promote a culture of ethics, transparency, and accountability.
• Establish mechanisms for reporting, investigating, and resolving compliance concerns.
• Partner with business leaders to embed compliance into everyday decision-making.
• Evaluate and implement compliance technologies, analytics tools, automation solutions, and AI-enabled capabilities that enhance monitoring, reporting, and risk management.
• Ensure the responsible use of AI and emerging technologies within compliance operations.

Qualifications

• Bachelor’s degree required; advanced degree (JD, MBA, MPH, MS, or equivalent) preferred
• 10+ years of compliance experience within biotechnology or pharmaceuticals
• Demonstrated success building or significantly enhancing compliance programs in biotechnology or pharmaceutical environments
• Strong knowledge of FDA regulations, OIG guidance, Anti-Kickback Statute, Sunshine Act requirements, healthcare fraud and abuse laws, and related compliance frameworks
• Experience leading investigations, monitoring activities, auditing programs, and compliance risk assessments
• Ability to influence senior leaders and drive cross-functional alignment