Director, Healthcare Compliance

Intellia•Cambridge, MA

5d•Hybrid

About The Position

Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together. The Director, Healthcare Compliance will play a critical role in building and managing Intellia’s Healthcare Compliance Program in preparation for the launch of Intellia’s first product, a gene editing therapy in Phase 3 development for hereditary angioedema (HAE). This role will build, implement, and continuously improve Intellia’s Healthcare Compliance Program through close partnership with the Commercial and Medical Affairs organizations, cross-functional collaboration, and a collective commitment to uphold Intellia’s integrity. This position will report to the Vice President, Commercial and Development Law & Head of Healthcare Compliance, and will be Intellia’s first dedicated healthcare compliance hire. This role requires a proven track record of healthcare compliance leadership and a strong desire to provide support across a fast-paced organization preparing to launch a novel therapy.

Requirements

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
B.A./B.S. degree required, JD strongly preferred
8+ years of healthcare compliance and/or other related experience in biotech/pharmaceutical organization
Prolonged periods of sitting at a desk and working on a computer

Nice To Haves

experience in rare disease is a plus

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.