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

Preferred / Desirable

Leadership & Competencies

Key Metrics / Success Measures

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.

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals Hiring Managers seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigals name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g. fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.

Please also note that any correspondence with regard to employment would come from an authorized email address or from an email address from one of our trusted search firm partners. We are aware that incorrect / fraudulent email addresses with Madrigal misspelled have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal we recommend that you : do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to .

Required Experience :

Exec

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 316000 - 386000