Director / Senior Director, Regulatory Affairs Advertising and Promotion

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

Immunome is seeking a highly experienced and strategic Director / Senior Director, Regulatory Affairs Advertising and Promotion to provide regulatory leadership for U.S. advertising, promotional labeling, and medical communications across our oncology portfolio. This role will partner with Commercial, Medical Affairs, Legal, and Compliance to enable compliant and competitive communication strategies from early launch planning through post-launch execution.

The successful candidate will bring deep expertise in FDA advertising and promotion regulations and OPDP practices, strong judgment and risk-based decision making, and proven leadership in medical-legal-regulatory review environments. This position offers an opportunity to build Immunome’s Advertising & Promotion capabilities as we prepare for and execute commercial launches.

Responsibilities

Strategic Leadership

• Develop and execute the U.S. regulatory Advertising & Promotion (A&P) strategy across the product lifecycle, from pre-launch planning through post-market execution.
• Provide strategic guidance on promotional positioning, claims, and evidence requirements in alignment with approved labeling, clinical data, and internal standards.
• Serve as the internal subject matter expert on FDA advertising and promotion regulations and guidance, including awareness of OPDP enforcement trends and best practices.

Promotional Review and Risk Management

• Serve as the regulatory lead for Immunome’s Medical-Legal-Regulatory (MLR) committee to ensure consistent, timely , and compliant review of materials. <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4&quo