Director, Ethics and Compliance
Invivyd
4 hours ago
Remote friendly (New Haven, CT)
United States
$184,000 - $245,000 USD yearly
Corporate Functions
Responsibilities:
- Develop, evolve, and oversee implementation of policies, procedures, and guidance aligned with applicable laws, rules, regulations, guidance, industry codes, and company policies.
- Periodically update relevant policies and procedures, tailored to business-associated risks.
- Lead or assist in development of a privacy program; counsel internal clients on privacy matters and permissible data uses for strategic initiatives, and apply privacy laws/regulatory guidance to business processes, research collaborations, and commercial partnerships.
- Develop and implement communications, trainings, and other content to help employees understand policies/guidance and their accountability for a compliant, ethical organization.
- Assist in development and rollout of Compliance training and communications to Sales, Marketing, Market Access, Medical Affairs, and other relevant departments.
- Assist in execution of a compliance monitoring program, including field rides, observation of speaker programs, advisory boards, and sponsorship activities.
- Manage implementation/deployment of compliance systems (e.g., HCP engagement tools, sponsorship submissions/approvals) and coordinate with vendors/third parties to support the compliance program.
- Support the design and execution of compliance risk assessments.
- Foster an internal compliance/ethics/“speak-up” culture; position Compliance as a strategic partner.
- Advise business partners on potential compliance risks related to strategies and tactics.
- Assist in review and authorization of transactions per company policy, including HCP engagements and commercial sponsorships.
- Assist in preparation for compliance committee meetings.
- Provide additional support for ethics and compliance strategies and goals.
Requirements:
- 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 experience with relevant laws and regulations, including:
- U.S. anti-kickback laws (Federal Antikickback Statute)
- Physician Payments Sunshine Act
- Pharmaceutical industry laws/regulations
- U.S. privacy and consumer protection laws
- PhRMA Code on Interactions with Healthcare Professionals
- Experience conducting internal monitoring.
- Knowledge of commercial, compliance, and regulatory matters for launch and commercialization of branded pharmaceutical products.
- Knowledge of compliance and data privacy laws/standards (e.g., AKS, Sunshine Act, OIG HHS Compliance Program Guidance, HIPAA, and state privacy laws).
- Ability to build strong relationships and work effectively with cross-functional teams, multiple management levels, external advisors, and others.
- Travel: to corporate office 2–4x/month; periodically ~20%.
Pay Range:
- $184,000 - $245,000 base salary.
- Eligible for annual short-term incentive (bonus/sales incentive) and annual long-term incentive (equity).
Application:
- Visit https://www.invivyd.com/careers/.
- Develop, evolve, and oversee implementation of policies, procedures, and guidance aligned with applicable laws, rules, regulations, guidance, industry codes, and company policies.
- Periodically update relevant policies and procedures, tailored to business-associated risks.
- Lead or assist in development of a privacy program; counsel internal clients on privacy matters and permissible data uses for strategic initiatives, and apply privacy laws/regulatory guidance to business processes, research collaborations, and commercial partnerships.
- Develop and implement communications, trainings, and other content to help employees understand policies/guidance and their accountability for a compliant, ethical organization.
- Assist in development and rollout of Compliance training and communications to Sales, Marketing, Market Access, Medical Affairs, and other relevant departments.
- Assist in execution of a compliance monitoring program, including field rides, observation of speaker programs, advisory boards, and sponsorship activities.
- Manage implementation/deployment of compliance systems (e.g., HCP engagement tools, sponsorship submissions/approvals) and coordinate with vendors/third parties to support the compliance program.
- Support the design and execution of compliance risk assessments.
- Foster an internal compliance/ethics/“speak-up” culture; position Compliance as a strategic partner.
- Advise business partners on potential compliance risks related to strategies and tactics.
- Assist in review and authorization of transactions per company policy, including HCP engagements and commercial sponsorships.
- Assist in preparation for compliance committee meetings.
- Provide additional support for ethics and compliance strategies and goals.
Requirements:
- 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 experience with relevant laws and regulations, including:
- U.S. anti-kickback laws (Federal Antikickback Statute)
- Physician Payments Sunshine Act
- Pharmaceutical industry laws/regulations
- U.S. privacy and consumer protection laws
- PhRMA Code on Interactions with Healthcare Professionals
- Experience conducting internal monitoring.
- Knowledge of commercial, compliance, and regulatory matters for launch and commercialization of branded pharmaceutical products.
- Knowledge of compliance and data privacy laws/standards (e.g., AKS, Sunshine Act, OIG HHS Compliance Program Guidance, HIPAA, and state privacy laws).
- Ability to build strong relationships and work effectively with cross-functional teams, multiple management levels, external advisors, and others.
- Travel: to corporate office 2–4x/month; periodically ~20%.
Pay Range:
- $184,000 - $245,000 base salary.
- Eligible for annual short-term incentive (bonus/sales incentive) and annual long-term incentive (equity).
Application:
- Visit https://www.invivyd.com/careers/.