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:
We are a pre-commercial gene-editing company developing potential once-and-done therapies for serious diseases. Our in vivo gene-editing therapy for hereditary angioedema (HAE) is pending FDA review and poised to become the first in vivo gene-editing therapy, if approved, to reach the U.S. market. Our two global Phase 3 trials in transthyretin (TTR) amyloidosis: one in cardiomyopathy and one in polyneuropathy are well underway.
Head of Clinical Development, reporting to the CMO, will be a member of the development leadership team, accountable for partnering closely with key stakeholders in defining development strategy and oversight of clinical development activities across Intellia portfolio, including HAE and TTR. The successful candidate will be responsible for leading the cross-functional Clinical Development Team, providing strategic and medical leadership for clinical development activities of product and pipeline candidates across disease areas, in alignment with corporate strategy. This position requires a highly motivated physician scientist with hands-on expertise and player coach collaborative leadership style in advancing product candidates to deliver life-changing medicines.
Responsibilities:
Build and lead a team of Medical Directors and Clinical Scientists, accountable for working collaboratively with key stakeholders in development to define development strategy and plan across company portfolio, including life-cycle management activities
Lead cross-functional Clinical Development Team meetings, providing strategic and medical leadership of clinical development activities across company products and pipelines, including HAE and TTR
Collaborate with other members of the development leadership team to contribute to building a collaborative culture and improving effectiveness of the development team
Drive scientifically robust evaluation of development strategy and plans, including robust literature review to assess development landscape, evaluation of development and regulatory pathways
Engage with external scientific and clinical trial experts, clinical and regulatory consultants, to develop scientifically robust study designs
Provide strategic guidance and leadership to the medical director and clinical science team, including hands-on authoring of clinical and regulatory documents, such as clinical sections of regulatory submissions, study protocols, investigator brochures, publications
Serve as lead author in clinical responses to regulatory authorities, related to review of protocols, INDs, BLA/MAA/JNDA, and other regulatory filings
Provide medical leadership and input in cross-functional team activities, including business development activities, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety
Responsible for medical oversight of clinical trials, including medical monitoring of studies, adverse event reporting, and patient safety for all clinical trials across a development…