Deputy General Counsel, Commercial & Healthcare Compliance

Summary

Join Nuvalent, a dynamic early-stage company in the oncology drug development field, as their Deputy General Counsel, Commercial & Healthcare Compliance. Reporting to the Chief Legal Officer, you will be responsible for designing, implementing, and maintaining a global healthcare compliance program. This crucial role involves providing legal counsel for the commercialization of the company's first pharmaceutical product and collaborating with cross-functional teams. Extensive experience as a brand attorney with a focus on commercial legal counsel and medical/promotional review is essential. Success in this position requires expertise in compliance program development, policy creation, training, auditing, and monitoring. You will partner with various departments to lead and support commercial and compliance initiatives, enhancing compliance awareness throughout the organization.

Requirements

• J.D. from an accredited law school and member in good standing of the Massachusetts bar or the ability to obtain a limited in-house counsel registration in Massachusetts and a minimum of ten (10) years of relevant experience with a demonstrated in-depth understanding of applicable legal, regulatory and compliance matters affecting pharmaceutical and biotechnology organizations
• Prior commercial launch experience is essential
• In-depth knowledge of commercial, compliance and regulatory matters related to the launch and subsequent commercialization of branded pharmaceutical products, including a thorough under-standing of healthcare laws and regulations and corporate governance issues related to development and commercialization of biopharmaceutical products, including without limitation US Federal healthcare program requirements under the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, OIG guidelines and opinions, the Sunshine Act, FCPA. fraud and abuse, transparency, and other healthcare compliance matters
• Demonstrate an ability to solicit and integrate business feedback from various stakeholders in the development of commercial and compliance programs, policies and guidelines
• Appreciate complex and nuanced commercial and compliance matters, with an ability to engage in strategic discussions with business teams to optimize the Company’s position
• Collaborate fluidly with all members of the Legal Team relating to a broad range of topics and special projects and demonstrate ability to multi-task, problem-solve and operate in a fast-paced environment
• Excellent analytical, written and verbal communication skills with a track record of preparing and delivering effective and engaging presentations and training programs to teams

Responsibilities

• Provide business-oriented and compliance-minded commercial legal advice to cross-functional product-focused teams and stakeholders involved in Nuvalent’s launch-readiness activities
• Partner with the legal team and key stakeholders to design, build, implement and maintain a robust and effective U.S. and global comprehensive healthcare compliance program that is right- sized for Nuvalent as it transitions to a commercial organization, including the development of a range of policies, procedures training, and auditing and monitoring programs
• Provide legal advice to the business to ensure compliance with applicable U.S. laws and Company policies, including federal and state antikickback and false claims laws, the federal Food Drug and Cosmetic Act (FDCA) laws, the PhRMA Code, anti-bribery, fraud and abuse, state laws, federal and state transparency laws, and antitrust laws
• Review and advise on promotional and medical materials and strategies, and participate in other relevant commercial and medical affairs committees, as needed
• Collaborate with, and provide value-added guidance to multiple stakeholders, including drafting and negotiating contracts for commercial activities, relevant service agreements, consulting agreements, pricing agreements and government and payer contracts
• Demonstrate an ability to solicit and integrate business feedback from various stakeholders in the development of commercial and compliance programs, policies and guidelines
• Work collaboratively across the business with cross-functional teams to ensure compliance, con-sistency and accuracy in outward interactions, including without limitation corporate communica-tions materials, scientific exchange, advisory boards, market research, sponsorships and grants, dis-ease awareness materials, and promotional materials if the Company’s products are approved
• Disseminate information to educate, and train employees regarding a broad spectrum of compliance-related topics, including promoting (a) use of the compliance hotline, (b) heightened awareness of the Code of Business Conduct and Ethics and (c) understanding of new and existing compliance issues in our industry and related policies and procedures
• Foster a strong internal compliance, ethics, and “speak-up” culture by creating an environment in which employees see Compliance as a strategic partner
• Develop process for and oversee compliance with applicable state and federal transparency and aggregate spend reporting laws (and non-US country laws, as applicable) and regulations
• Lead the evaluation, investigation, and resolution of  compliance issues/concerns within the organization
• Serve as a well-respected, credible subject matter expert throughout the organization, with the ability to provide business-oriented, practical guidance across a wide array of substantive commercial and compliance areas
• Maintain awareness of legislation, pharmaceutical, regulatory and policy initiatives in order to counsel business leaders on potential legal risks in a way that continues to advance corporate strategy while protecting corporate assets, integrity and reputation
• Proactively identify potential legal risks, and formulate and communicate practical solutions that meet corporate strategic objectives and priorities

Preferred Qualifications

• At least two years of in-house experience at a commercial biotechnology or pharmaceutical company with an oncology or rare diseases business
• Experience advising a company through its initial commercial launch