Jobs · Massachusetts

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

    Qualifications

    • 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

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