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:
As the Head of Safety, this is an opportunity to build Intellia's Pharmacovigilance department from the ground up. Reporting to the Chief Medical Officer, you will be responsible for executing short-term objectives while developing a long-term vision and strategy for monitoring and protecting the safety of patients receiving our novel CRISPR/cas 9 gene therapies. You and your team's responsibilities will include:
Developing processes, policies, and standard operating procedures (SOPs) including the timing, selection, and implementation of a safety database
Collaborate with members of the clinical development team in the development and implementation of clinical protocols, safety management plans, data monitoring committee charters, informed consent form (ICF) risk template language, and safety events adjudication.
Contribute to the Investigator Brochures (IBs), periodic safety reports such as Development Safety Update Report (DSURs), and responses to regulatory authorities
Author integrated safety summary (ISS), safety sections of the clinical study report (CSR), and participate as needed in regulatory meetings
Develop and implement cross-platform safety assessments, risk-benefit profiles, signal detection plans, and risk management plans.
Medical review of individual case safety reports (ICSRs)
Monitor and evaluate the performance of a contract research organization’s (CRO) pharmacovigilance activities
Collaborate with development partners on safety data exchange and lead/collaborate on industry-wide safety efforts
Are you an experienced safety physician who is excited by the challenge of creating a state-of-the-art pharmacovigilance department? Our ideal candidate will be able to apply their in-depth knowledge of good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines to monitor and protect patient safety. If you describe yourself as a strong team leader who encourages career development among team members, we encourage you to apply!
Meet your future team:
The Clinical Development Team at Intellia is made up of one or more people in functions related to clinical research, including but not limited to biometrics, clinical operations, clinical pharmacology, medical science, medical writing, project leadership, project management, and regulatory affairs. We are here because we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and we believe Intellia has the right people, strategy, and culture to do it well.
The team is led by our CMO, a physician and medical oncologist with over 25 years of experience in large pharma and biotech drug development. Other senior team members have 10 or more years of similar experience, including many with prior direct experience in nucleic acid therapeutics and cell therapy. Your medical colleagues at Intellia are physicians and scientists who share responsibility across the three development-stage programs as Project Leads and Medical Leads. Their responsibility will increase in the coming years as Intellia’s pipeline moves further into clinical development.
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.