Senior Director, Advertising and Promotion

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.

The Sr. Director, Advertising and Promotion is a strategic role leading the review and approval and submission of advertising and promotional materials, related training, and other nonproduct commercial communications.  The Sr. Director will also be responsible for developing and managing labeling globally. In this role, you will be responsible for ensuring compliance with regulatory agencies’ requirements and Invivyd’s promotional, medical, and corporate communications objectives. Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new and updated regulations and guidance documents for both labeling and promotion.

The Sr. Director, Advertising and Promotion will also coordinate training pertaining to advertising, promotion, and product launch activities.  The individual will work collaboratively with medical affairs, legal, compliance, and commercial teams in the development and implementation of advertising and promotional processes and materials for Invivyd’s product portfolio. 

The ideal candidate is someone who thrives in a fast-paced environment, is a strategic problem solver, and is proactive, flexible, detail-oriented, and hands-on.

• →Represents Regulatory Affairs as a member of cross-functional commercial review committee, providing regulatory input into the review and approval of promotional and nonpromotional materials
• →Maintain a deep and current awareness of evolving US and global regulations, Codes and guidelines, enforcement actions and policy issues affecting the pharmaceutical/biotech Industry as it pertains to labeling and promotion
• →Effectively partner and collaborates with Medical Affairs, Legal, Compliance, Commercial, and other stakeholders as needed to ensure that promotional and non-promotional materials are reviewed in a timely fashion throughout the product life cycle
• →Primary Liaison with OPDP and effectively manages relationships with FDA contacts
• →Provide strategic regulatory advice for labeling taking into consideration marketing use post-approval
• →Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management
• →Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities

• Doctorate, Master's, or Bachelor's degree in a relevant/scientific discipline (graduate degree preferred)
• Minimum of eight years working in the pharmaceutical or biotech industry with a minimum of 10-15 years in Regulatory Affairs
• Experience working with OPDP
• Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion
• Knowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to EU and international Requirements is a plus
• Ability to work in a fast-paced environment where drive is critical to success
• Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence all business functions in order to reach resolution
• Strong writing, project management and communication skills
• Ability to travel as needed (2x a month) to our New Haven, CT office

The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.