Senior Director, Compliance

Role:
Senior Director, Compliance at a biotech transitioning to commercialization, leading the development and execution of the company's compliance program to support launch readiness.

• establish compliance policies, procedures, governance, and risk management frameworks
• advise cross-functional teams on healthcare laws and regulations
• oversee monitoring, audits, investigations, and third-party compliance
• promote a culture of ethics and transparency
• implement compliance training and communication programs
• evaluate and deploy compliance technology solutions

• Bachelor’s degree
• 10+ years in compliance within biotech or pharma
• deep knowledge of FDA regulations, healthcare fraud laws, Anti-Kickback Statute, Sunshine Act
• successful track record building or enhancing compliance programs
• ability to influence senior leadership and drive cross-functional alignment

• advanced degrees (JD, MBA, MPH, MS)
• experience with compliance in immunotherapy or oncology fields
• expertise in leveraging analytics, automation, and AI tools for compliance management

High Value: biotech/pharma compliance, healthcare laws adherence, risk management, cross-functional partnership with Commercial, Medical, Regulatory, Legal, and Finance teams, remote work, no travel specified.

Work Setup:
Fully remote.