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.
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.
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.
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.
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.
Excellent analytical, written, and verbal communication skills with a track record of preparing and delivering effective and engaging presentations and training programs to teams.
Benefits
medical, dental, and vision insurance
401(k) retirement savings plan
generous paid time off (including a summer and winter company shutdown)