Vice President, Global Promotional Advertising and Regulatory Affairs

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 liver-directed THR-β 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).

Our success is driven by our people. We are building a dynamic inclusive and high-performing culture that values scientific excellence operational rigor and collaboration. To support our continued growth we are strengthening our workforce strategy to ensure we have the right talent at the right time in the right way.

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.S. and internationally. This role ensures that promotional materials campaigns labeling and other communications comply with applicable regulatory requirements (e.g. Food and Drug Administration (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 subject matter expertise cross-functional leadership (Marketing Medical Affairs Legal/Compliance Regulatory Operations) and the ability to guide risk-based decisions represent the company in regulatory interactions (e.g. FDAs Office of Prescription Drug Promotion (OPDP)) and drive high-quality processes and metrics.

Key Responsibilities

• 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 subject matter 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. ISI/brief summary) and ensure labeling consistency. 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. FDA OPDP) including submissions (e.g. Form 2253) advisory requests and responses to enforcement letters or competitor complaints.
• Provide strategic regulatory advice and risk-based assessments to cross-functional 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 subject matter 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 cross-border materials or campaigns are used.
• Ensure appropriate database/record-keeping for promotional materials including submissions approvals regulatory correspondence internal review archives and audit readiness
• Other duties as assigned

Required & Desired Qualifications

• Bachelors degree in Life Sciences (e.g. Biology Chemistry Pharmacy) required; advanced degree (PharmD PhD MS) strongly preferred.
• 20 years of relevant experience in regulatory affairs advertising & promotion (Ad/Promo) review general regulatory strategy and labeling knowledge and commercial compliance. Minimum of 1015 years of experience in the pharmaceutical/biologics industry.
• Deep knowledge of U.S. FDA advertising & promotion and labeling regulations (including but not limited to OPDP Form 2253 submissions enforcement letters) and ideally familiarity with global regulatory codes of practice and international Ad/Promo requirements.
• Demonstrated ability to operate cross-functionally in a matrixed environment collaborate with Commercial Medical Affairs Legal/Compliance Regulatory and other stakeholders influencing without direct authority.
• Strong strategic analytical and risk-management mindset: ability to interpret complex regulatory standards provide clear regulatory positions and businessoriented advice and support launch assets and marketed brands.
• Excellent verbal and written communication skills; 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 team building experience (either direct or indirect) preferred with ability to mentor and develop regulatory professionals.

Preferred/Desirable

• Experience in a therapeutic area with high regulatory scrutiny (e.g. oncology rare diseases biologics) or major product launches.
• Global/regional experience (nonU.S.) 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/multi-channel promotional communications (e.g. online social media) in a regulatory context.

Leadership & Competencies

• 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 cross-functional teams communicate effectively at senior leadership level.
• Agile and adaptable: able to work in a dynamic fast-paced environment manage ambiguity and changing requirements.
• Operational excellence orientation: seeks continuous improvement in process metrics systems.
• Mentorship mindset: able to build team capability teach/adapt regulatory updates foster a culture of compliance and business partnership.

Key Metrics/Success Measures

• 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/promotional compliance.
• Efficiency metrics: review cycle times number of materials cleared process improvement initiatives implemented.
• Stakeholder satisfaction: 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 subject-matter 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. Full-time employees are eligible for base salary bonus equity and a comprehensive benefits suite.

Base salary is determined by several factors including the candidates qualifications skills education experience business needs and market demands. As of the date of this posting a good faith estimate of the current pay scale for this position applicable to all candidates is $316000 - $386000 per year. We comply with all applicable minimum wage laws.

All full-time 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.

Full-time employees are also eligible for comprehensive benefits including flexible paid time off medical dental vision and life/disability insurance and 401(k) offerings (i.e. traditional Roth and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance legal services and other addition we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal state and local laws.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance please contact

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications merit and business need. Applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin age disability protected veteran or disabled status or other characteristic protected by applicable federal state or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.

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