Director / Senior Director, Regulatory Affairs Advertising & Promotion

Position Overview

Immunome is seeking a highly experienced and strategic Director / Senior Director, Regulatory Affairs Advertising & Promotion to provide regulatory leadership for U.S. advertising, promotional labeling, and medical communications across our oncology portfolio.

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.
• Review and approve promotional labeling, advertising, and external communications (HCP and consumer, digital/social, congress, speaker programs, sales training, and other materials as applicable) for compliance with regulations, guidance, and company SOPs.
• Drive risk identification and mitigation plans; document regulatory rationale and provide clear, practical feedback to cross-functional stakeholders and agency partners.
• Regulatory Submissions and Agency Interactions
• Oversee preparation, quality control, and timely submission of promotional materials (e.g., FDA Form 2253 submissions) and maintain submission tracking, records, and archives.
• Lead or support OPDP interactions related to promotional materials, advisory comments, requests for information, and response development in collaboration with Regulatory leadership and Legal.
• Policy, Training, and Compliance
• Establish, maintain, and continuously improve A&P policies, SOPs, templates, and review standards to increase consistency and efficiency.
• Develop and deliver training for cross-functional teams and vendors on promotional regulations, scientific exchange, and compliant communications.
• Monitor FDA guidance, industry trends, and enforcement actions to proactively update internal standards and advise leadership on emerging risks and opportunities.
• Leadership and Collaboration
• Build and mentor a high-performing A&P team; set clear objectives, provide coaching, and foster a culture of collaboration and accountability.
• Act as a strategic partner to Commercial, Medical Affairs, Market Access, and Patient Advocacy teams to enable effective, compliant communication strategies.
• Manage external agencies and vendors supporting promotional development, ensuring alignment with regulatory strategy, submission requirements, and compliance expectations.

Qualifications

• A minimum of 10+ years of Regulatory Affairs experience in the biopharmaceutical industry with significant focus on U.S. advertising and promotion (A&P) review experience in oncology with product launch experience, or equivalent.
• Demonstrated experience leading regulatory review of promotional materials in a MLR environment, including omnichannel and digital/social communications.
• Strong knowledge of FDA advertising and promotion regulations, promotional submission requirements (e.g., FDA Form 2253), Subpart E/H, and other related regulatory activities, as applicable
• Proven track record supporting product launches and lifecycle management, including pre-approval communications and early commercialization planning.
• Experience interacting with OPDP and managing responses to regulatory comments, advisory feedback, or enforcement actions.
• Experience in a fast-paced, growth-stage biotech environment strongly preferred.

Knowledge and Skills

• In-depth knowledge of U.S. promotional regulations, FDA/OPDP guidance, and current enforcement trends. Experience in oncology is a plus.
• Strong ability to translate scientific and clinical data into compliant claims and messaging frameworks; excellent judgment in risk-benefit assessment.
• Proven leadership and influence skills with the ability to drive timely decisions and alignment across cross-functional stakeholders.
• Excellent written and verbal communication skills, including the ability to provide clear, actionable feedback to teams and agencies.
• Demonstrated success developing, implementing, and improving A&P processes, SOPs, and training programs.
• Highly organized with strong project management skills and the ability to manage multiple products and competing priorities.
• Collaborative, solutions-oriented mindset with strong stakeholder management and conflict resolution skills.
• Experience managing and developing staff and external vendors/partners.

Washington State Pay Range

$222,933 - $310,500 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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