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Invivyd · 3 hours ago

Director, Ethics and Compliance

New Haven, CT

Full-time

Hybrid

Director/Executive

8+ years exp

Invivyd is a company focused on delivering protection from serious viral infectious diseases, including COVID-19. They are seeking an experienced healthcare compliance professional to design and implement an effective compliance program, ensuring adherence to healthcare-related laws and fostering a culture of compliance within the organization.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Work collaboratively across the business to help develop, evolve and oversee implementation of policies, procedures, and guidance that are right sized for Invivyd and reflective of existing and updates to applicable laws, rules, regulations, guidance, industry codes, and Company policies

Periodically update relevant policies and procedures, ensuring they are appropriately tailored to the risks associated with the business

Lead or assist in the development of a comprehensive privacy program, right-sized for Invivyd and counsel internal clients on a wide range of privacy matters, including permissible data uses for strategic initiatives and the application relevant privacy laws and regulatory guidance to current business processes, research collaborations, and commercial partnerships

Develop and implement engaging communications, trainings, and other content to help employees understand company policies and guidance and be accountable for their role in building and maintaining a compliant and ethical organization

Assist in the development and roll-out of Compliance training and communication to Sales, Marketing, Market Access, Medical Affairs, and other relevant departments

Assist in the execution of a comprehensive compliance monitoring program relevant to each business function, including periodic field rides, observation of speaker programs, advisory boards, and sponsorship activities

Manage implementation and deployment of Compliance systems (e.g., end-to-end HCP engagement tools, sponsorship submissions and approvals) and coordinate with vendors, third parties and others to support the development, implementation, and maintenance of the compliance program

Support the design and execution of compliance risk assessments

Foster a strong internal compliance, ethics, and “speak-up” culture by creating an environment in which employees see Compliance as a strategic partner

Provide advice and counsel to business partners from across the entire organization, evaluating business strategies and tactics for potential compliance risks

Assist in review and authorizing transactions where indicated by company policies, including HCP engagements and commercial sponsorships

Assist in preparation for compliance committee meetings

Provide additional support for ethics & compliance strategies and goals

Qualification

U.S. healthcare complianceCompliance program developmentPrivacy complianceCompliance certificationsRisk assessmentsInternal monitoringEthicsCompliance cultureCross-functional collaborationCommunication skills

Required

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 experience in pharmaceutical industry

Subject matter experience with relevant laws and regulations, including: U.S. anti-kickback laws and regulations, including the Federal Antikickback Statute, The Physician Payments Sunshine Act, Laws and regulations governing pharmaceutical industry, US 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 subsequent commercialization of branded pharmaceutical products

Knowledge of compliance and data privacy laws and standards, including but not limited to AKS, Sunshine Act, OIG HHS Compliance Program Guidance, HIPAA, and state privacy laws

Ability to develop strong working relationships and work effectively with cross-functional teams, multiple levels of management, external advisors, and others

Must be able to travel to the corporate office 2-4x/month

Ability to periodically travel (approximately 20%)