VP, US Regulatory Affairs Strategy

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s 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).

Position Responsibilities

This position is an opportunity to have a broad influence on the leadership, development, and success of Madrigal Pharmaceuticals as it builds its presence in the US and beyond. Specifically, the VP, US Regulatory Affairs Strategy will be expected to:

• Lead the U.S regulatory function and build a regulatory infrastructure to ensure regulatory support for US submissions.
  • Provide oversight of regulatory-related launch and post-marketing activities in the US.
  • Ensure all post-marketing requirements and maintenance activities are met.
  • Ensure product information is maintained in national databases.
  • Ensure all packaging and labeling requirements are met according to local requirements.
• Work closely with the Regulatory Affairs team in the US to develop and implement the global regulatory strategy for the company’s products.
• Provide regulatory leadership and strategic guidance regarding various domestic requirements for development and registration of Madrigals’ products.
• Act as the principal liaison with FDA for original product approvals and maintenance, including negotiation and maintenance of labelling.
• Lead the preparation of documents for inclusion in original FDA submissions and label extensions. Reviews key documents related to clinical development and registration of products.
• Ensure that the company’s products remain in regulatory compliance.
• Keep abreast of new FDA regulatory requirements and anticipate their future impact on Madrigal.
• Prepare an annual budget and operate within that budget.
• Lead the regulatory input for US business development opportunities and partner with the EU VP of Reg Strategy for international opportunities.
• Lead and develop the US regulatory team in a manner that inspires ongoing commitment and enables excellence.
• Promote a positive work environment by communicating a clear direction on goals, provide support to other areas and work in a fashion consistent with Madrigals’ values.

Experience And Professional Qualifications

The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical company:

• Established regulatory leader with substantial industry experience in US and international markets in Regulatory Affairs. Global RA experience is advantageous.
• Proven track record of directly leading the regulatory submission and approval process of new therapeutics through FDA procedures and other national agencies
• Experience in scaling the product beyond the US market and managing multiple products simultaneously
• Experience with high-value therapeutics, specifically experience in Liver / MASH is desirable.
• Established relationships with domestic regulatory bodies.
• Involvement in or meaningful exposure to shaping regulatory policy externally.
• Demonstrated ability to work in a multidisciplinary setting, acting as a creator and facilitator to drive the fulfillment of corporate strategic goals.

Critical Competencies For Success

The ideal candidate displays the following professional competencies:

• Profound / Strong scientific and technical skills in order to perform in role
• Strong interpersonal capabilities and ability to build and maintain networks
• Ability to anticipate and resolve problems effectively
• Strong verbal communication and technical writing skills
• Fluent in English language
• Ability to present clearly using scientific and regulatory terminology
• Sound organizational skills
• Comfort with ambiguity
• Display a sense of urgency; identify challenges and problems and take initiative to identify solutions
• Project management skills and focus on delivery of results
• Ability to develop high functioning team and effectively delegate
• Ability to deliver executive briefings and board-level updates

Education & Experience

• Bachelor’s degree as a minimum; preference in Life Sciences or a related discipline
• Higher qualifications (MD, PhD, MBA) advantageous
• At least 15 years of experience in growing roles in a similar environment in the biopharmaceutical industry

Compensation

Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

Equal Opportunity

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.

Agency Submissions

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.

Fraud Warning

Please be aware that we are currently receiving numerous 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 Madrigal’s 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. Interviews with Madrigal are conducted via the Zoom platform.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com 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 Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.