Director, Ethics and Compliance
Invivyd
13 hours ago
Remote friendly (New Haven, CT)
United States
$184,000 - $245,000 USD yearly
Corporate Functions
Responsibilities:
- Design, build, implement, and maintain an effective healthcare compliance program that embeds a culture of compliance.
- Develop, evolve, and oversee policies, procedures, and guidance aligned with applicable laws, regulations, industry codes, and Company policy; periodically update and tailor to business risks.
- Lead or support a privacy program; counsel internal teams on privacy matters, including permissible data uses and applying privacy laws to business processes, research collaborations, and partnerships.
- Create and implement communications, trainings, and content to ensure employees understand policies and guidance; support compliance training/communication roll-out to Sales, Marketing, Market Access, Medical Affairs, and other departments.
- Assist with execution of a comprehensive compliance monitoring program (e.g., field rides, speaker programs, advisory boards, sponsorship activities).
- Manage and deploy compliance systems (e.g., HCP engagement tools, sponsorship submissions/approvals) and coordinate with vendors/third parties.
- Support compliance risk assessments.
- Foster a speak-up compliance/ethics culture; advise business partners on potential compliance risks.
- Review and authorize transactions per company policies (including HCP engagements and commercial sponsorships); support compliance committee preparation; provide additional ethics/compliance strategy support.
Requirements/Qualifications:
- Bachelor’s degree in a relevant field.
- Compliance and/or Legal background with strong business partnership orientation; law degree or compliance certifications a plus.
- 8+ years of U.S. healthcare compliance experience in the pharmaceutical industry.
- Subject matter expertise in: Anti-kickback laws (Federal Antikickback Statute), Physician Payments Sunshine Act, pharmaceutical industry laws/regulations, U.S. privacy and consumer protection laws, PhRMA Code.
- Experience conducting internal monitoring.
- Knowledge of commercial, compliance, and regulatory matters for launch and commercialization of branded pharmaceuticals.
- Knowledge of compliance and data privacy laws/standards (e.g., AKS, Sunshine Act, OIG HHS Compliance Program Guidance, HIPAA, state privacy laws).
- Ability to work with cross-functional teams and multiple levels of management.
- Travel: corporate office 2–4x/month; periodic travel ~20%.
- Design, build, implement, and maintain an effective healthcare compliance program that embeds a culture of compliance.
- Develop, evolve, and oversee policies, procedures, and guidance aligned with applicable laws, regulations, industry codes, and Company policy; periodically update and tailor to business risks.
- Lead or support a privacy program; counsel internal teams on privacy matters, including permissible data uses and applying privacy laws to business processes, research collaborations, and partnerships.
- Create and implement communications, trainings, and content to ensure employees understand policies and guidance; support compliance training/communication roll-out to Sales, Marketing, Market Access, Medical Affairs, and other departments.
- Assist with execution of a comprehensive compliance monitoring program (e.g., field rides, speaker programs, advisory boards, sponsorship activities).
- Manage and deploy compliance systems (e.g., HCP engagement tools, sponsorship submissions/approvals) and coordinate with vendors/third parties.
- Support compliance risk assessments.
- Foster a speak-up compliance/ethics culture; advise business partners on potential compliance risks.
- Review and authorize transactions per company policies (including HCP engagements and commercial sponsorships); support compliance committee preparation; provide additional ethics/compliance strategy support.
Requirements/Qualifications:
- Bachelor’s degree in a relevant field.
- Compliance and/or Legal background with strong business partnership orientation; law degree or compliance certifications a plus.
- 8+ years of U.S. healthcare compliance experience in the pharmaceutical industry.
- Subject matter expertise in: Anti-kickback laws (Federal Antikickback Statute), Physician Payments Sunshine Act, pharmaceutical industry laws/regulations, U.S. privacy and consumer protection laws, PhRMA Code.
- Experience conducting internal monitoring.
- Knowledge of commercial, compliance, and regulatory matters for launch and commercialization of branded pharmaceuticals.
- Knowledge of compliance and data privacy laws/standards (e.g., AKS, Sunshine Act, OIG HHS Compliance Program Guidance, HIPAA, state privacy laws).
- Ability to work with cross-functional teams and multiple levels of management.
- Travel: corporate office 2–4x/month; periodic travel ~20%.