Madrigal Pharmaceuticals is hiring: Vice President, Global Promotional Advertisi

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigals medication Rezdiffra (resmetirom) is a once-daily oral liverdirected THR agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). We are building a dynamic, inclusive and high-performing culture that values scientific excellence, operational rigor and collaboration. The Head of Global Promotional Advertising & Regulatory Affairs leads and oversees the regulatory strategy review and governance of all advertising, promotional and scientificexchange communications (both internal and external) for prescription pharmaceutical/biologic products in the U.This role ensures that promotional materials, campaigns, labeling and other communications comply with applicable regulatory requirements (e.g. FDA regulations, enforcement precedent, industry codes of practice, international laws and regulations) while enabling the commercial objectives of the organization. Drawing on industry benchmarks the role requires deep regulatory subjectmatter expertise, crossfunctional leadership (Marketing, Medical Affairs, Legal/Compliance, Regulatory Operations) and the ability to guide riskbased decisions. The head represents the company in regulatory interactions (e.g. FDAs Office of Prescription Drug Promotion (OPDP)) and drives highquality processes and metrics. Develop and lead the global regulatory advertising & promotion (Ad & Promo) strategy for the companys marketed products and pipeline assets in alignment with brand/commercial plans and overall regulatory strategy. Serve as the regulatory subjectmatter expert for promotional communications: advertising sales aids, digital channels, medical education, disease awareness, conference exhibits and scientific exchange materials. Ensure all materials comply with applicable laws, regulations, guidance documents and internal policies (e.g. FDA OPDP, state laws, industry codes, international laws and regulations). Manage and mentor staff supporting the promotional review process including review of concepts, claims, safety/risk language (e.g. Monitor and respond to enforcement trends, advisory comments and regulatory inquiries. Manage and mentor staff and/or act directly as a primary liaison with regulatory agencies (e.g. Form 2253), advisory requests and responses to enforcement letters or competitor complaints. Provide strategic regulatory advice and riskbased assessments to crossfunctional stakeholders (Commercial, Marketing, Medical Affairs, Legal/Compliance, Regulatory Affairs operations) facilitating timely and compliant promotional launch campaigns and ongoing support for marketed products. Develop, implement and maintain standard operating procedures (SOPs), guidelines, training programs, quality metrics and dashboards for the Ad & Promo review process ensuring operational excellence and continuous improvement. Monitor and interpret regulatory developments (e.g. FDA guidance updates, industry enforcement actions, global codes of practice) and proactively update the business on implications for promotional communications and risk mitigation. Mentor, build and lead the regulatory advertising & promotion team fostering subjectmatter expertise, leadership, collaboration and stakeholder engagement across the organization. Support global/regional harmonization of advertising & promotion regulatory framework including collaboration with international/regional regulatory Ad & Promo leads to ensure consistency where crossborder materials or campaigns are used. Ensure appropriate database/recordkeeping for promotional materials including submissions, approvals, regulatory correspondence, internal review archives and audit readiness. Bachelors degree in Life Sciences (e.g. advanced degree (PharmD, PhD, MS) strongly preferred. ~20 years of relevant experience in regulatory affairs advertising & promotion (Ad/P`o) review, general regulatory strategy and labeling knowledge and commercial compliance. Minimum of 1015 years of experience in the pharmaceutical/biologics industry. ~ FDA advertising & promotion and labeling regulations (including but not limited to OPDP, Form 2253, enforcement letters) and ideally familiarity with global regulatory codes of practice and international Ad/P`o requirements. ~ Demonstrated ability to operate crossfunctionally in a matrixed environment, collaborate with Commercial, Medical Affairs, Legal/Compliance, Regulatory and other stakeholders influencing without direct authority. ~ Strong strategic, analytical and riskmanagement mindset: ability to interpret complex regulatory standards, provide clear regulatory positions and businessoriented advice and support launch assets and marketed brands. ~ ability to articulate regulatory rationale, prepare correspondence/briefing documents for senior management and deliver training. ~ Experience with promotional review systems/document management tools (e.g. Veeva PromoMats) and metrics/tracking of review performance is preferred. ~ Leadership and teambuilding experience (either direct or indirect) preferred with ability to mentor and develop regulatory professionals. Experience in a therapeutic area with high regulatory scrutiny (e.g. oncology, rare diseases, biologics) or major product launches. in advertising & promotion regulatory matters or global brand support. Experience working with or interacting with regulatory authorities on advisory comments, competitor complaints or enforcement issues. Experience developing or optimizing promotional review processes, SOPs, dashboards and training programs to drive operational efficiency and compliance robustness. Demonstrated ability to support digital/multichannel promotional communications (e.g. online social media) in a regulatory context. Strategic thinker able to align regulatory needs with commercial objectives. High integrity and sound judgment: able to balance business opportunity and regulatory risk. Influencer and collaborator: able to drive consensus in crossfunctional teams and communicate effectively at senior leadership level. Agile and adaptable: able to work in a dynamic, fastpaced environment, manage ambiguity and changing requirements. Mentorship mindset: able to build team capability, teach/adapt regulatory updates, foster a culture of compliance and business partnership. Timeliness and quality of promotional material review and approval for assigned products/campaigns. Compliance metrics: zero or minimal regulatory enforcement findings, internal audit findings related to ad/promotion compliance. Efficiency metrics: review cycle times, number of materials cleared, process improvement initiatives implemented. Commercial/Marketing, Medical Affairs, Legal/Compliance feedback on regulatory partnership clarity of guidance and responsiveness. Regulatory risk mitigation: proactive identification of potential issues, regulatory strategy effectiveness for launches and ongoing brand communication. Team development and capability building: regulatory ad/promo team growth, training completion, subjectmatter expertise. Alignment with business objectives: supporting launch of new products enabling promotional campaigns while maintaining compliance. Madrigal offers a competitive Total Rewards strategy to attract and retain top talent and is inclusive of base pay, bonus, equity and a generous benefits package. Fulltime employees are eligible for base salary, bonus, equity and a comprehensive benefits suite. We comply with all applicable minimum wage laws. All fulltime employees receive equity which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance we empower employees to think like owners, giving them a stake in the organization. Fulltime employees are also eligible for comprehensive benefits including flex]]