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 Director/Senior Director, Development Operations, Infrastructure and Innovation, you will be a member of the Development Operations Leadership team and report into the Vice President, Development Operations. This is a key member of the Development Operations team and will partner closely with the Clinical Operations, Clinical Development, Biometrics, Information Technology (IT), and the Intellia Quality organization to build and lead teams to drive compliance and operational excellence within the Clinical Development organization. In addition, this leader will develop and foster operational interfaces and greater measures of efficient and compliance with contract research organization partners (CROs) and other key vendors.
You will be responsible for:
- Responsibility for Clinical Development and Clinical Operations systems, metrics, and dashboards, trial master file, external spend oversight, resource planning, and capability planning
- Partner with CRO Outsourcing and Alliance Management and Strategic Sourcing:
- Establish methods to measure and report on key program deliverables, timelines, finances, quality and compliance in the outsourced operational model
- Participate in strategic relationship oversight, management, and issue resolution with CROs or key vendors
- Work within Clinical Development to:
- Identify innovative and implement robust processes and tools to enhance clinical study operations, compliance and execution
- Identify and lead strategic initiatives and capabilities planning to scale to meet long range planning demand
- Oversees Clinical Development/Operations systems and metrics infrastructure, and develops, generates, analyzes and benchmarks data/metrics/key performance indicators/key quality indicators to support the management clinical trials
- In partnership with key stakeholders:
- Prioritize, identify and establish best practices and systems to optimize clinical operations
- Implementing and maintaining Clinical Development/Operations systems and metrics that support efficient delivery of clinical trials
- Identify and drive the implementation of key information technology, business systems, data requirements and other key vendor systems integration representing Development Operations
- Implement the eTMF system, build out the eTMF team and oversee eTMF management
- Ensure inspection readiness of eTMF and other documentation areas
- Facilitate the Clinical Development/ Operations annual budget and workforce planning, monthly accrual process, quarterly forecasting, and oversight of spend in partnership with the clinical operations team
- Instills a culture of continuous improvement, enhanced compliance and performance excellence driven; acts as a change champion and effectively leads change
- Maintain awareness of biopharmaceutical business, operational trends, and external organizational developments to help define future strategic direction.
- Provides leadership in a highly matrixed environment, and will mentor Clinical Operations professionals.
You are a subject matter expert (SME) and key clinical development team member who would embrace the challenge to create an innovative operational approaches and solutions to support Intellia’s CRISPR/cas9 programs.
- Minimum of a completed Bachelor's degree, Master’s degree a plus
- 10+ years) experience with a CRO or biopharmaceutical company with strong knowledge associated with GCP and inspection readiness activities
- Experience and knowledge of operational approaches, global regulatory needs and compliance requirements for clinical trials
- Experience with CRO and vendor management
- Knowledge of IT systems and other technologies to support global clinical trials
- Inspection readiness and participation in regulatory and or other audits or inspections
- Thorough understanding of the global drug development process and project management knowledge desired
- Solid interpersonal and communication skills and the ability to appropriately interact with all levels of management, including executive management within Intellia and the CROs/vendors
- Ability to manage teams/individuals and provide career development and mentor staff
Meet your future team:
The Clinical Development 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. It 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.
The team is led by our Vice President, Development Operations, a pharmacist with a Masters degree in Business with over 25 years of experience in 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.
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.