General Counsel /
Full Time /
At Madrigal, we are committed to transforming treatment for patients with non-alcoholic steatohepatitis (NASH). NASH will soon become the leading cause of liver transplantation in the U.S., but there are currently no approved medications to treat the disease.
Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist that is designed to target key underlying causes of NASH in the liver. Positive results from the first of two Phase 3 clinical trials of resmetirom in NASH were announced in January 2022; and results from a second Phase 3 clinical trial in December of 2022. We are excited to announce NDA Acceptance and Priority Review with an assigned Prescription Drug User Fee Act date of March 14, 2024 for resmetirom for the Treatment of NASH with Liver Fibrosis.
Madrigal has established its leadership position in NASH by staying true to its science-driven foundation and building a company culture based on collaboration and trust. Our team members are focused on delivering results for the benefit of healthcare providers, and most importantly, patients. These values will remain central to Madrigal as the company grows and evolves its commercial capabilities to prepare for a potential first-to-market launch in NASH.
Opportunity and Summary of Position:
We are looking for an experienced lawyer to join us as Brand Counsel. This position will advise Madrigal’s Commercial, Market Access, and Medical Affairs functions on issues related to product commercialization, including pre-launch activities. If you have a passion for bringing new treatments to patients with unmet needs and a thorough understanding of the laws governing pharmaceutical sales and marketing, we invite you to join our growing team.
This position provides counsel concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals. The ideal candidate for this role will be a personable, practical legal advisor with an understanding of the False Claims Act, Food, Drug & Cosmetic Act, Anti-Kickback Statute, and other healthcare laws. You will have high visibility throughout the organization, supporting core business activities and providing counsel to cross-functional teams. You will be empowered to develop strong and positive working relationships with colleagues at all levels. Experience in pharmaceutical / life sciences advising, ability to work in a fast-paced environment, and willingness to be a flexible, business-oriented team player are required.
Partnering cross-functionally to provide legal advice related to Marketing and Market Access, including reviewing all promotional materials and concepts
Partnering with Medical Affairs to advise on scientific exchange and review all medical and materials
Working closely with Madrigal’s Compliance department to foster a culture of compliance in Madrigal’s interactions with healthcare professionals, including the conduct of advisory boards and market research, including by reviewing related materials
Engaging as a member of cross-functional teams to ensure that grants and other funding are compliant and aligned with corporate goals
Draft, negotiate, review, and revise commercial and market access agreements associated with the business, including healthcare professionals, providers, vendors, licensors, consultants and speaker agreements; master services agreements, statements of work, sales, supply, distribution, PBM, GPO, Wholesaler, discount and rebate, distribution vendor and service agreements
Communicating legal advice to business stakeholders in an authentic and understandable way
Juris Doctorate and admission to a state bar (or eligibility for in-house counsel admission)
5-7 years legal experience across life science companies, including experience advising pharmaceutical or other life sciences clients is required. Specialty product launch experience within the pharmaceutical or biotech industry experience is highly preferred
Experience with FDA laws and regulations and a deep understanding of the applicable laws and regulations, particularly the U.S. Anti-Kickback Statute and False Claims Act
Prior experience on promotional and non-promotional review committees is required
Proven ability to counsel clients effectively
Willingness to work in a fast-paced environment and handle multiple, conflicting priorities while managing a substantial workload
Proven ability to execute on complex projects and lead them to successful completion
Madrigal is an equal opportunity employer
Madrigal is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.