Senior Counsel, Product

The Company:
With deep expertise in chemistry Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company bringing together experienced scientists and industry veterans with a proven track record in drug discovery oncology drug development and company building.

The Role:

Reporting to the Deputy General Counsel Commercial and Compliance the Senior Counsel Product will be a critical part of Nuvalents Legal Department and will contribute significantly to the success of our growing this role you will be responsible for advisement on a host of strategic and tactical issues related to the development and future commercialization of prescription drug products. Responsibilities will include advising on matters governed by healthcare fraud and abuse laws FDA regulations state and federal drug pricing and transparency laws access and reimbursement matters privacy laws and providing legal guidance on patient support programs. The Senior Counsel Product will act as the brand lawyer and reviewer on the Promotional Materials Review Committee and the Medical Review Committee. This role will also support cross functional compliance initiatives and other key projects across the organization. We are looking for an attorney with product launch experience a proactive mindset and solution orientation to join the Nuvalent team.

Responsibilities:

• Serve as a legal advisor on a broad range of commercialization-related subjects in support of anticipated launch of companys 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.
• Serve as a legal business partner to market access team
• 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 distribution agreements GPO agreements rebate agreements specialty pharmacy agreements vendor agreements service agreements consulting agreements and sponsorships.
• 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

Competencies include:

• 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 objectives
• Clear communication style that effectively conveys advice and recommendations to key stakeholders
• A demonstrated track record of acting with integrity and a collegial solution-oriented mindset
• A champion of a positive and respectful company culture

Qualifications:

• 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
• Juris Doctor from an accredited law school; active membership and in good standing in a state bar and either admitted to the Massachusetts bar or eligible for admission to the Massachusetts bar as in-house counsel
• Significant knowledge of enforcement trends the Federal Food Drug and Cosmetic Act and related regulations the False Claims Act and laws related to fraud and abuse in the life science/biotech/pharma industries
• 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.

Nuvalentprovides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion race creed color sex sexual orientation alienage or citizenship status national origin age marital status pregnancy disability veteran or military status predisposing genetic characteristics or any other characteristic protected by applicable federal state or local law.

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