Director, Healthcare Compliance

Role Summary

The Director, Healthcare Compliance will lead the development and ongoing management of Intellia’s Healthcare Compliance Program in preparation for the launch of the company’s first product, a gene editing therapy in Phase 3 for hereditary angioedema (HAE). The role will build, implement, and continuously improve the program through close partnership with Commercial and Medical Affairs, cross-functional collaboration, and a commitment to integrity. It reports to the Vice President, Commercial and Development Law and Head of Healthcare Compliance and will be Intellia’s first dedicated healthcare compliance hire.

Responsibilities

• Build and manage key elements of Intellia’s Healthcare Compliance Program in accordance with laws and industry guidance, including OIG Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the Food Drug and Cosmetic Act (FDA), the Physician Payments Sunshine Act, and other pharmaceutical laws and regulations.
• Serve as a primary business partner helping Commercial and Medical leadership execute their product launch objectives while managing compliance risk.
• Assist in development, implementation, and oversight of healthcare compliance policies and procedures prioritized by ongoing risk assessments and commercial infrastructure buildout.
• Curate the healthcare compliance training syllabus and develop and deliver virtual and live trainings tailored to Intellia’s business.
• Develop and implement a risk-based monitoring plan for essential policies and procedures and partner cross-functionally to facilitate auditable record-keeping.
• Partner cross-functionally to establish Intellia’s systems and processes for aggregate spend reporting.
• Work closely with Legal colleagues and the Head of Healthcare Compliance to evaluate compliance risks and resolve compliance matters.
• Report to and advise Intellia’s Risk Oversight and Compliance Committee on accomplishments, challenges, and the overall effectiveness of Intellia’s Healthcare Compliance Program.
• Maintain understanding of Intellia’s business objectives and activities and keep abreast of industry and enforcement trends that may impact Intellia’s operations and Healthcare Compliance Program.
• Promote Intellia’s values and establish “Compliance by Design” principles as integral to achieving business objectives and improving processes and decision-making.
• As part of a growing and evolving business, this role will have the opportunity for a diverse workload, visibility as a leader, and continued development opportunities.

Qualifications

• Unimpeachable integrity, good judgment, assertiveness, an approachable demeanor, and the ability to elicit the respect and trust of employees
• Deep knowledge of pharmaceutical laws, regulations and industry guidance pertaining to the commercialization of biopharmaceutical products
• Broad experience in the biopharmaceutical industry and understanding of key commercial activities, including sales and marketing, HCP and patient engagements and interactions, product distribution, market access, and patient support services; experience in rare disease is a plus
• Self-starter who can lead projects independently from inception to completion with minimal supervision
• Excellent communications skills, both verbal and written, including the ability to effectively lead presentations and deliver trainings
• Exceptional organizational skills and attention to detail
• Solid track record of building strong working relationships in a cross-functional matrix environment, working with different personality types, and managing conflict
• Strong work ethic, positive outlook, commitment to legal and business teams
• Collaborative style; team player
• Experience: 8+ years of healthcare compliance and/or other related experience in biotech/pharmaceutical organization

Education

• B.A./B.S. degree required, JD strongly preferred

Additional Requirements

• Physical requirements: Prolonged periods of sitting at a desk and working on a computer