Director / Senior Director, Regulatory Affairs Advertising & Promotion

Bothell2d ago

Seniority: Lead

About the role

<div class="content-intro">Company Overview <div class="x_elementToProof" data-olk-copy-source="MessageBody">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 submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.</div></div>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. 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  <ul> <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="1" data-aria-level="1">Develop and execute the U.S. regulatory Advertising & Promotion (A&P) strategy across the product lifecycle, from pre-launch planning through post-market execution. </li> <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="1" data-aria-level="1">Provide strategic guidance on promotional positioning, claims, and evidence requirements in alignment with approved labeling, clinical data, and internal standards. </li> <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="1" data-aria-level="1">Serve as the internal subject matter expert on FDA advertising and promotion regulations and guidance, including awareness of OPDP enforcement trends and best practices. </li> </ul> Promotional Review and Risk Management  <ul> <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" data-aria-level="1">Serve as the regulatory lead for Immunome’s Medical-Legal-Regulatory (MLR) committee to ensure consistent, timely, and compliant review of materials. </li> <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" data-aria-level="1">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. </li> <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" data-aria-level="1">Drive risk identification and mitigation plans; document regulatory rationale and provide clear, practical feedback to cross-functional stakeholders and agency partners. </li> </ul> Regulatory Submissions and Agency Interactions  <ul> <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="7" data-aria-level="1">Oversee preparation, quality control, and timely submission of promotional materials (e.g., FDA Form 2253 submissions) and maintain submission tracking, records, and archives. </li> <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="7" data-aria-level="1">Lead or support OPDP interactions related to promotional materials, advisory comments, requests for information, and response development in collaboration with Regulatory leadership and Legal. </li> </ul> Policy, Training, and Compliance  <ul> <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="9" data-aria-level="1">Establish, maintain, and continuously improve A&P policies, SOPs, templates, and review standards to increase consistency and efficiency. </li> <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="9" data-aria-level="1">Develop and deliver training for cross-functional teams and vendors on promotional regulations, scientific exchange, and compliant communications. </li> <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="9" data-aria-level="1">Monitor FDA guidance, industry trends, and enforcement actions to proactively update internal standards and advise leadership on emerging risks and opportunities. </li> </ul> Leadership and Collaboration  <ul> <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="12" data-aria-level="1">Build and mentor a high-performing A&P team; set clear objectives, provide coaching, and foster a culture of collaboration and accountability. </li> <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="12" data-aria-level="1">Act as a strategic partner to Commercial, Medical Affairs, Market Access, and Patient Advocacy teams to enable effective, compliant communication strategies. </li> <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="12" data-aria-level="1">Manage external agencies and vendors supporting promotional development, ensuring alignment with regulatory strategy, submission requirements, and compliance expectations. </li> </ul>   Qualifications <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Pharm.D., Ph.D., M.S., or other advanced degree in life sciences or related field; B.S. with commensurate experience will be considered. </li> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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. </li> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Demonstrated experience leading regulatory review of promotional materials in a MLR environment, including omnichannel and digital/social communications. </li> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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 </li> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Proven track record supporting product launches and lifecycle management, including pre-approval communications and early commercialization planning. </li> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Experience interacting with OPDP and managing responses to regulatory comments, advisory feedback, or enforcement actions. </li> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Experience in a fast-paced, growth-stage biotech environment strongly preferred. </li> </ul> Knowledge and Skills  <ul> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">In-depth knowledge of U.S. promotional regulations, FDA/OPDP guidance, and current enforcement trends. Experience in oncology is a plus. </li> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Strong ability to translate scientific and clinical data into compliant claims and messaging frameworks; excellent judgment in risk-benefit assessment. </li> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Proven leadership and influence skills with the ability to drive timely decisions and alignment across cross-functional stakeholders. </li> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Excellent written and verbal communication skills, including the ability to provide clear, actionable feedback to teams and agencies. </li> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Demonstrated success developing, implementing, and improving A&P processes, SOPs, and training programs. </li> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Highly organized with strong project management skills and the ability to manage multiple products and competing priorities. </li> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Collaborative, solutions-oriented mindset with strong stakeholder management and conflict resolution skills. </li> <li data-leveltext="" data-font="Symbol" data-listid="16" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Experience managing and developing staff and external vendors/partners. </li> </ul>   This role may be performed either onsite at our Bothell, WA location or remotely within the U.S.<div class="content-pay-transparency"><div class="pay-input"><div class="title">Washington State Pay Range</div><div class="pay-range">$222,933—$310,500 USD</div></div></div><div class="content-conclusion">E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: <a href="https://immunome.box.com/s/bopxukipfidxjscs4bjxt75f90bvpppk" target="_blank">E-Verify Participation Poster</a> | <a href="https://immunome.box.com/s/r51g9subw1wqni9xkutbl6up635sjr8e" target="_blank">Right to Work Poster (English)</a> | <a href="https://immunome.box.com/s/r3ekbimwh988my9vzl76tnlbg60zvh9u" target="_blank">Right to Work Poster (Spanish)</a>.</div>

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