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 Chief Legal Officer, the Deputy General Counsel, Commercial & Healthcare Compliance is responsible for designing, implementing and maintaining an effective global healthcare compliance program and for providing legal advice to guide the Company in the commercialization of its first pharmaceutical product.
Previous and deep experience as a brand attorney, providing commercial legal counsel to business clients, and engaging in medical and promotional review is key to success in this role. Experience in guiding the development of compliance programs and policies, conducting relevant training and operating a robust auditing and monitoring program is also required. This role will partner with our teams in legal, commercial, medical affairs, regulatory, global quality, value & access, patient advocacy, corporate communication, human resources and finance, among others, and will work closely and cross-functionally to lead and support commercial and compliance initiatives, and to raise the level of awareness of compliance within Nuvalent.
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
Competencies include:
• A professional leadership presence/demeanor, as well as an extremely positive and responsible working attitude
• Comfortable working in a fast-paced, results-driven, highly accountable environment, with a demonstrated ability to parallel process multiple projects with competing timelines
• Ability to communicate effectively with personnel at all levels of the organization and to inspire confidence and support for compliance initiatives
• Demonstrated ability to think strategically and pay close attention to detail
• Ability to work collaboratively in teams with a practical, solution-oriented approach
• Strong project management skills and ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure
• Self-motivated, able to work independently and be reliable, responsible and accountable
Qualifications:
• 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
• At least two years of in-house experience at a commercial biotechnology or pharmaceutical company with an oncology or rare diseases business strongly preferred
• Prior commercial launch experience is essential; experience advising a company through its initial commercial launch preferred
• 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
Nuvalent provides 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.
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.