Senior Director, Healthcare Compliance

Job Summary
 

The Senior 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.

Duties/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.
• Develop, implement, and oversee 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.

Requirements

Skills/Abilities

• 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

Education / Certifications

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

Experience

• 10+ years of healthcare compliance and/or other related experience in biotech/pharmaceutical organization

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer

#LI-Hybrid

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Applications are accepted on a rolling basis, and will continue to be accepted until the position is filled at which point the position will be taken down.

The base salary for this position is expected to range between $267,431.00 - $326,860.00 USD per year.

The salary offered is determined based on a range of factors including, but not limited to, relevant education and training, overall related experience, specialized, rare or in-demand skill sets, internal comparators and other business needs. Upon joining Intellia, your salary will be reviewed periodically and additional factors such as time in role and performance will be considered. Intellia may change the published salary range based on company and market factors.

Additional compensation includes a performance-based annual cash bonus, a new hire equity grant, and eligibility to be considered for annual equity awards the value of which are determined annually at the Company’s discretion.

For more information about Intellia’s benefits, please click here.