Senior Counsel, Commercial

Role Summary

Senior Counsel, Commercial at Nuvalent provides strategic and tactical legal advisement related to the development and future commercialization of prescription drug products. The role covers healthcare fraud and abuse, FDA regulations, pricing and transparency laws, access and reimbursement, privacy, and patient support programs, with opportunities to support cross-functional compliance initiatives. A product-launch mindset and ability to deliver practical, proactive guidance to the cross-functional brand team and other stakeholders are essential.

• Serve as a legal advisor on a broad range of commercialization-related subjects in support of anticipated launch of company’s first oncology product to the cross functional brand team, including marketing, medical affairs, market access, sales, and other key stakeholders.
• Serve as an experienced subject matter expert and review committee member for advertising, promotional and non-promotional materials, and medical materials, including sales and marketing materials, market access materials, patient support program information, disease education, scientific exchange, press releases, and clinical trial recruitment activities.
• Provide legal advisement on the design and implementation of sales and marketing strategy, market access activities, patient support programs, medical affairs initiatives, media campaigns, and interactions with patients and patient advocacy organizations
• Provide ad-hoc advice on contracts with health care fraud and abuse, FDA or brand related implications.
• Advise on commercialization-related contracts and engagements, including, vendor agreements, service agreements, consulting agreements, statements of work, and sponsor ships.
• Serve as a legal representative on cross functional project teams, as assigned, to support business initiatives, identify and mitigate legal risks and to foster collaboration across other legal and compliance disciplines as appropriate.
• Assist in the development of the enterprise-wide compliance program
• Additional responsibilities as assigned

• Experience as the legal representative on a promotional review committee and a medical materials review committee in the pharmaceutical industry
• Experience in advising on healthcare fraud and abuse laws
• Experience advising on matters governed by FDA regulations
• Experience advising on patient support programs and market access initiatives
• Ability to provide responsive, thoughtful, pragmatic and clear advice in support of business
• Clear communication style that effectively conveys advice and recommendations to key stakeholders
• Experience thriving in a fast-paced environment with a solutions-oriented approach
• A demonstrated track record of acting with integrity and a collegial, solution-oriented mindset
• A champion of a positive and respectful company culture

• Juris Doctor from an accredited law school; active membership and in good standing in a state bar (Massachusetts bar membership or eligibility for admission to the Massachusetts bar as in-house counsel)

• 7+ years of recent relevant legal experience in product support of biotech/pharma, with a strong preference for experience with launching a product in the U.S. market and 3+ years in-house pharmaceutical or biotech oncology experience
• Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, laws related to fraud and abuse in the life science/biotech/pharma industries, transparency laws, and the PhRMA Code.
• Familiarity with ex-US frameworks (e.g., EFPIA, GDPR) preferred
• Experience with pharmaceutical/biotech commercial contracting preferred
• Team player with strong and effective collaboration and communication skills
• Ability to travel as required to support business activities.