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Vice President, Chief Compliance and Privacy Officer

New England (Boston/Waltham preferred)

ABOUT US

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.

At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2.  Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.

Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.

Be part of making a difference. Be part of Invivyd.

Position Title: Vice President, Chief Compliance and Privacy Officer

Position summary:

Invivyd is seeking an experienced healthcare compliance professional to take a leadership role in designing, building, implementing and maintaining an effective healthcare compliance program and ensuring that a culture of compliance is woven into the fabric of the organization, at all levels and in all departments.  This role will also serve as the Privacy Officer for Invivyd.  This includes overseeing privacy compliance, data governance and strategy, and privacy incident management and response. 

Reporting to the Chief Legal Officer, the Vice President, Chief Compliance & Privacy Officer will be a key member of the Legal and Compliance Leadership Team and a key part of the Company’s leadership, supporting Invivyd’s evolving business and shaping the company’s culture to enable achievement of the Company’s goals and objectives in a compliant and ethical manner. Responsibilities include strategically designing and hands-on building of the healthcare compliance program and working collaboratively across the business to set the tone and direction for Invivyd’s compliance and ethics program to ensure that the Company is well-positioned to comply with applicable healthcare-related laws, rules, regulations, guidance, and industry codes and meet the requirements of the Company’s Code of Business Ethics and Conduct.

Responsibilities include, but are not limited to, the following:

  • Design, build, implement and maintain a robust and effective U.S. (and global, as applicable) compliance and ethics program that is right sized for Invivyd
  • Develop strategies for and oversee day-to-day operations of Invivyd’s compliance and ethics program
  • Develop, implement, and oversee a pragmatic enterprise risk management framework
  • Work collaboratively across the business to develop, evolve and oversee implementation of policies, procedures, and ways of working that are right sized for Invivyd and reflective of existing and updates to applicable laws, rules, regulations, guidance, industry codes, and Company policies
  • Keep abreast of FDA rules and regulations governing the advertising and promotion of pharmaceuticals; maintain current knowledge of enforcement actions and policy, code, guidance and other communications and expectations for pharmaceutical industry healthcare compliance programs in the U.S. and globally, as required
  • Develop and implement engaging communications, trainings, and other content to help employees understand and be accountable for their role in building and maintaining a compliant and ethical organization
  • Develop and implement efficient auditing and monitoring plans and other oversight programs for key areas of risk that can prevent, identify, detect and correct non-compliance with applicable laws, rules, regulations, guidance, industry codes, and Company policies
  • Foster a strong internal compliance, ethics, and “speak-up” culture by creating an environment in which employees see Compliance as a strategic partner
  • Effectively manage timely investigations into allegations of violations of applicable laws, rules, regulations, industry codes, and/or Company policies and recommend corrective action where appropriate
  • Develop process for and oversee compliance with applicable state and federal laws (and non-US country laws, as applicable) and regulations that require reporting of transfers of value, interactions with healthcare providers (e.g., Physician Payments Sunshine Act), and other activities
  • Develop policies and process for and oversee compliance related to interactions with healthcare providers (e.g., needs assessments, fair market value), and other industry activities (e.g., medical education grants, charitable donations and commercial/medical sponsorships)
  • Chair and oversee Invivyd’s Compliance Committee to ensure appropriate cross-functional collaboration when implementing Invivyd’s compliance and ethics program
  • Report on the status of the compliance and ethics program and risk management activities to the Leadership Team and/or the Board of Directors and/or Audit Committee
  • Recruit, lead and manage one or more compliance professionals
  • Manage and coordinate with vendors, third parties and others to support the development, implementation, and maintenance of the compliance program (e.g., reporting hotline; federal and state HCP/HCO reporting and requisite systems modifications for spend tracking; support learning management system implementation and oversight; Fair Market Value analyses for HCPs and Market Access; debarment screening; state law drug price transparency). Effectively manage associated budgets for these projects
  • Build and lead a strategic and comprehensive Privacy program that defines, develops and implements policies and processes to enable consistent, effective privacy practices that comply with applicable federal, state, and ex-US laws (e.g., General Data Protection Regulation) and that minimize risk and ensure confidentiality of personal protected information including protected health information
  • Counsel internal clients on a wide range of privacy matters, including permissible data uses for strategic initiatives and the application of global privacy laws and regulatory guidance to current business processes, new product development, research collaborations and commercial partnerships
  • Provide additional support for legal, compliance, functional, and/or corporate strategies and goals

Requirements:

  • JD from an ABA-accredited law school and/or healthcare compliance certification preferred, and a minimum of ten (10) years of relevant experience in both developing (e.g., strategy, materials, system identification) and then implementing healthcare and corporate compliance programs in the pharmaceutical/biotech industry in leadership roles
  • A successful track record helping to build a culture of compliance and ethics in which compliance and business objectives are mutually reinforcing and establishing effective reporting, monitoring, and auditing programs
  • In-depth understanding of the pharmaceutical industry with expertise in the body of laws, rules, regulations, guidance, and applicable industry codes impacting pharmaceutical companies
  • In-depth knowledge of commercial, compliance and regulatory matters related to the launch and subsequent commercialization of branded pharmaceutical products
  • Knowledge of global compliance and data privacy laws and standards, including but not limited to AKS, EKRA, Sunshine Act, OIG HHS Compliance Program Guidance, HIPAA, GDPR, and state privacy laws
  • Ability to periodically travel

At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

Invivyd is proud to be an equal opportunity employer.

We do not accept unsolicited resumes from agencies. 

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