Vice President, Compliance (Biopharma)

Nuvalent, Inc. • Cambridge, MA

14h

About The Position

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.
Reporting to the Chief Legal Officer, the VP, Compliance, will serve as the company’s senior compliance leader, responsible for designing, implementing, and overseeing a comprehensive and effective global healthcare compliance program aligned with applicable laws, regulations, and industry standards. The role is both strategic and hands-on: ideal for a leader who can set vision while rolling up their sleeves to build processes from the ground up. The VP, Compliance will be a trusted advisor to Nuvalent leadership and a partner across business units.

Requirements

• Minimum of 15 years of compliance experience in an organization subject to US pharmaceutical regulations; experience in oncology or rare disease business strongly preferred.
• Minimum of 5 years’ experience in an ethics and compliance leadership role.
• Bachelor’s degree required, law degree preferred but not required.
• Prior commercial launch experience is essential; experience guiding a company through its initial commercial launch is preferred.
• Willingness to travel up to 25% of time and conduct in-person training meetings.
• In-depth knowledge of compliance matters related to the launch and subsequent commercialization of branded pharmaceutical products, including a thorough understanding 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
• Experience applying a risk-based analysis to compliance issues and demonstrated creativity in developing solutions that satisfy both our requirements and legal obligations.
• Ability to serve multiple client groups by recognizing and responding quickly and pragmatically to urgent situations.
• Appropriate judgment on when to collaborate with Legal and business colleagues or outside counsel.
• 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

• Partner with the legal team and key stakeholders to 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
• Develop, refine and update policies and practices to facilitate global compliance and best practices.
• Advise on compliance matters including interpretation and application of Nuvalent's Code of Business Conduct, and Company policies.
• Lead implementation of our compliance training program.
• Lead implementation of our monitoring and auditing program, oversee audits and monitor the implementation of our compliance operations.
• Foster a strong internal compliance, ethics, and “speak-up” culture by creating an environment in which employees see Compliance as a strategic partner
• Lead the evaluation, investigation, and resolution of compliance issues/concerns within the organization
• Conduct periodic risk assessments and develop and implement a work plan to address risk.
• Develop process for and oversee compliance with applicable state and federal transparency and aggregate reporting laws (and non-US country laws, as appropriate) and regulations
• Lead and mentor compliance team and ensure appropriate and cooperative allocation of responsibilities.
• Serve as a well-respected, credible subject matter expert throughout the organization, with the ability to provide business-oriented, practical guidance
• Stay current on new laws, regulations, best practices, and enforcement trends.
• Such other responsibilities as assigned from time to time by Chief Legal Officer.

Benefits

• Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive