VP, Associate General Counsel

Location
Cambridge, MA, United States
Posted
Feb 12, 2021
Ref
L357
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
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.

How You Will Achieve More With Intellia:

We are seeking an experienced biopharmaceutical attorney to join and contribute toward making a big impact with our legal team as we develop human therapeutics using CRISPR/Cas9 technology. The ideal candidate has a strong background in the biotechnology industry supporting and providing advice on a broad range of strategic matters for the Company's regulatory, compliance, commercial, and privacy, and other corporate legal issues. Most importantly, the ideal candidate can live up to our Values of One, Explore, Disrupt and Deliver by being able to work with multiple cross-functional teams to look for innovative solutions to positively change the lives of patients with severe and life-threatening diseases.

Responsibilities:
  • Provide high quality, timely and practical legal advice, and guidance, identify, and help resolve critical legal and business issues arising from regulatory, pre-clinical, clinical, technical operations, and research and development activities.
  • Advise on regulatory requirements regarding investigational product submissions, clinical trials, drug safety management, and commercialization in the United States, Europe, and other key jurisdictions.
  • Provide practical legal advice relating to applicable laws and regulations, as well as contractual obligations, while proactively identifying and helping manage risk profile of the company.
  • Represent Intellia in interactions with FDA, EMA and other global agencies that may affect the company's development and commercialization plans.
  • Act as the legal internal stakeholder for cross-functional teams, such as development program teams or medical and legal review teams.
  • Work with the contracts team, as necessary, in drafting and negotiating contracts, including master services agreements, clinical trial agreements, supply agreements, and material transfer agreements.
  • Review and approve presentations, press releases, website materials, brochures, and other company communications (internal and external).
  • Manage relationship with outside law firms.
  • Counsel advise and train internal (and external) teams to ensure compliance with applicable laws and regulations and company policies and procedures.


Qualifications:
  • Licensed attorney with 14+ years of experience in the biotechnology/pharmaceutical industry, and at least 6 years in a biopharmaceutical company providing advice on clinical and commercial experience matters.
  • Excellent knowledge and experience advising clients on laws and regulations governing the biotechnology industry both in and outside the U.S., including FDA and EMA requirements, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, GDPR and other privacy laws, and product liability laws.
  • Demonstrated leadership qualities including experience managing cross-functional legal teams, as well as sound business and legal judgment, and strategic and analytical thinking.
  • Real-time risk management capabilities in a landscape with shifting regulations and guidance and capability to provide long-term vision for the company.
  • Self-motivated, practical, and interested in working on a wide range of legal matters to lead the Company on legal implications of its business strategy.
  • Experience working with all levels of management and key business stakeholders with a demonstrated ability to influence outcomes and effectively communicate legal risks to executive leadership and senior management.
  • Excellent organizational skills and able to work with a team to meet critical deadlines; flexible and capable of managing multiple projects simultaneously.


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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.