Director, Global Compliance
Zenas BioPharma · Waltham, MA · Yesterday
Hybrid$180k–$226k/yrFull-time
Key Responsibilities
- Support the build and continuous improvement of Zenas's global ethics and compliance program, ensuring alignment with organizational values, applicable laws, regulations, and industry codes
- Conduct and maintain periodic compliance risk assessments to identify, prioritize, and mitigate emerging risks
- Monitor changes in applicable laws, regulations, and industry guidance and translate them into actionable program updates
- Policies & Written Standards
- Draft, implement, and maintain compliance-related policies and procedures, including the effective rollouts across the organization
- Ensure policies are clear, practical, and aligned to the needs of a growing, commercially oriented organization
- Training & Education
- Develop and deliver compliance training programs and awareness communications for employees and key stakeholders, with emphasis on field-based roles
- Misconduct & Risk Monitoring
- Design and integrate compliance controls into company processes to support effective risk management
- Conduct and oversee routine and risk-based monitoring and auditing of key business activities and related policies
- Third-Party Risk Management
- Manage and support third-party due diligence activities, including ongoing oversight of key high-risk vendors
- Cross-Functional Partnership
- Serve as a trusted compliance advisor to business partners across Commercial, Medical Affairs, Market Access, and other functions
- Provide independent compliance guidance to help manage and mitigate organizational risk
- Bachelor's degree required
- 5–8 years of progressive healthcare compliance experience within a pharmaceutical, biotechnology, or medical device organization
- Experience supporting first commercial launch preferred
- Solid understanding of the elements of an effective compliance program, including DOJ and HHS OIG guidance
- Deep knowledge of US healthcare fraud and abuse laws (Anti-Kickback Statute, False Claims Act), transparency laws and regulations (Sunshine Act), and the PhRMA Code on Interactions with Healthcare Professionals
- Familiarity with anti-bribery and anti-corruption legislation, including the Foreign Corrupt Practices Act (FCPA) and similar global regulations
- Experience with healthcare compliance systems, HCP engagement, transparency reporting, and third-party risk management
- Strong interpersonal and communication skills — clear, concise, and effective in both written and verbal formats across all levels of an organization
- Collaborative and cross-functional by nature; able to build trust and credibility with business partners while maintaining independence
- Solutions-oriented with the ability to analyze complex issues, anticipate risks, and propose practical, innovative compliance solutions with minimal supervisory input
- Comfortable operating in a fast-paced, results-driven environment with a high degree of accountability
- Flexible and adaptable; excited by the opportunity to build and evolve a compliance program alongside a growing, multicultural organization
- High degree of personal, professional, and corporate integrity
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint)
- Ability and willingness to travel up to 25% as needed