Senior Director, Clinical Operations
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 a Senior Director, Clinical Operations, you will report into the Vice President, Development Operations and are responsible for the clinical operations strategy execution and management of Intellia CRISPR/cas9 clinical program(s) in support of global clinical development plans. You will be responsible for key program deliverables, resource planning, key milestone and timeline development, financial planning/forecasting and budget management. Other main responsibilities include:
- This role will have multiple clinical operations direct reports at varying levels. This role will also manage and mentor a staff that have direct report responsibilities themselves in a dynamic matrix organization.
- Authoring and/or oversight of key study document development and implementation
- Responsible for the selection, oversight and quality performance of contract research organizations (CROs), central laboratories, and other key vendors
- Develop, collaborate and implement department standards, processes, and participate/lead in other key corporate or improvement initiatives
- He/she will provide clinical operations expertise in cross functional meetings and will directly work or manage teams that work closely with cross functional expertise areas to ensure overall compliance and quality in accordance with Intellia SOPs, ICH guidelines and GCP best practices.
- Proactively problem solve in a fast paced environment
- He./she will plan and manage internal and outsourced activities in order to ensure individual, team, department and corporate goals and objectives are met on time, with quality and within financial parameters
- Monitor and evaluate the Clinical Operations department performance, and the performance of contract research organizations’ (CROs) and key vendors’ outsourced activities
- Collaborate with development partners on development plans and deliverables, and lead/collaborate on CRISPR/cas9 development initiatives and industry wide initiatives
Are you are an experienced clinical operations leader who would embrace the challenge to create a thought-leading clinical operations department tasked with the delivering on a portfolio of CRISPR/cas9 gene editing development programs. The ideal candidate will be an experienced clinical operations professional who has the skills to apply knowledge of the good clinical practices and international regulatory requirements such as EMA/FDA/ICH guidelines.. If you describe yourself as a strong team leader and team player who encourages career development of team members, we encourage you to apply.
- Bachelor’s degree in health, sciences or related field
- Minimum of 12 years clinical operations experience, minimum of 5 years direct management experience
- Extensive CRO and vendor management experience; experience leading sponsor teams in on outsourced business operational model
- Strong leadership and management experiences, including employee development
- Excellent leadership, interpersonal, communication, strategic development, and operational skills
- Established ability to help identify potential operational and strategic issues and approaches to head off, or resolve issues
- Embraces a fast paced, cutting edge environment; ability to contribute and lead discussion in a high level team settings
- Maximum flexibility and team leading skill (in times of change)
Meet your future team:
The Clinical Operations Team at Intellia is here because we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and we believe the Intellia has the right people, strategy, and culture to do it well. The experienced team is led by our Vice President, Development Operations a pharmacist with over 25 years’ experience in biotech new product development. Other team members have 5-15 years of similar new product development experience in a biotech-outsourced operational model setting. This position will report to the Vice President, Development Operations.
Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. Requests for exemption for medical or sincerely held religious beliefs will be considered.
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.