Director, Ethics and Compliance

Role Summary

Invivyd is seeking an experienced healthcare compliance professional to join the Ethics & Compliance Team, reporting to the Vice President, Chief Ethics, Compliance & Privacy Officer. This individual will design, build, implement, and maintain an effective compliance program that embeds a culture of compliance across all levels and departments. The role involves hands-on program development, policy creation and updates, training, monitoring, risk assessment, and supporting privacy compliance, data governance, and incident response. The professional will help shape a compliant and ethical culture to enable the company’s goals.

Responsibilities

• Policies:
  • Work collaboratively to develop, evolve and oversee implementation of policies, procedures, and guidance aligned with laws, regulations, industry codes, and company policies
  • Periodically update policies and procedures to reflect risks and changes in the business
• Privacy:
  • Lead or assist in developing a comprehensive privacy program and counsel internal clients on privacy matters, including permissible data uses for strategic initiatives and applying privacy laws to processes, research, and partnerships
• Training, Communications, & Culture
  • Develop and implement trainings and communications to help employees understand policies and uphold a compliant and ethical organization
  • Assist in developing and rolling out Compliance training and communications to Sales, Marketing, Market Access, Medical Affairs, and other departments
• Monitoring:
  • Assist in implementing a comprehensive compliance monitoring program across functions, including field activities and program oversight
• Systems:
  • Manage implementation and deployment of Compliance systems and coordinate with vendors and third parties to support the program
• Risk Assessments:
  • Support design and execution of compliance risk assessments
• Culture, Partnership, and Guidance:
  • Foster a strong internal compliance and ‚Äúspeak-up‚Äù culture and provide counsel to business partners on potential compliance risks
• Operations:
  • Assist in review and authorization of transactions per policies (including HCP engagements and sponsorships)
  • Prepare for compliance committee meetings
  • Support ethics & compliance strategies and goals

Qualifications

• Bachelor's degree in a relevant field
• Compliance and/or Legal background with a strong business partnership orientation; law degree or compliance certifications a plus
• Eight or more years of experience in U.S. healthcare compliance in the pharmaceutical industry
• Subject matter experience with relevant laws and regulations, including:
  • U.S. anti-kickback laws and the Federal Anti-kickback Statute
  • The Physician Payments Sunshine Act
  • Laws and regulations governing the pharmaceutical industry
  • U.S. privacy and consumer protection laws
  • The PhRMA Code on Interactions with Healthcare Professionals
• Experience conducting internal monitoring
• Knowledge of commercial, compliance and regulatory matters related to the launch and commercialization of branded pharmaceutical products
• Knowledge of compliance and data privacy laws and standards (e.g., AKS, Sunshine Act, OIG/HHS Compliance Program Guidance, HIPAA, state privacy laws)
• Ability to develop strong working relationships and work effectively with cross-functional teams and management
• Must be able to travel to the corporate office 2‚Äì4 times per month
• Ability to travel periodically (approximately 20%)

Additional Requirements

• Equal opportunity employer; commitment to an inclusive environment