Senior Director, Commerical Legal Counsel

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

Job Title: Senior Director, Commercial Counsel

Location: Waltham, MA or Conshohocken, PA

Department: Legal Affairs

Reports To: General Counsel

Employment Type: Full-Time

Position Summary:

Madrigal Pharmaceuticals, a commercial-stage biopharmaceutical company, is seeking a highly skilled Senior Director, Commercial Counsel, to serve as a strategic legal partner to our Commercial, Medical Affairs, and Market Access teams. In this role, you will provide critical legal guidance on all aspects of product commercialization, launch, and ongoing market activities.

If you are passionate about delivering innovative treatments to patients with unmet needs, and you possess deep expertise in the laws and regulations governing pharmaceutical sales, marketing, and market access, we invite you to bring your talents to our dynamic and growing team.

Responsibilities

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 Sales, Marketing and Market Access, including reviewing all promotional materials and concepts
• Partnering with Medical Affairs to advise on scientific exchange and review of medical and materials as needed/in conjunction with other members of the legal department
• 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
• Communicating legal advice to business stakeholders in an authentic and understandable way

Qualifications

• Juris Doctorate and admission to a state bar (or eligibility for in-house counsel admission) and 15+ years of general legal experience
• 6-10 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
• This role will require 3 days per week in office

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.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis