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 CRO Outsourcing and Alliance Management, 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 Strategic Sourcing, Clinical Operations, Program Therapeutic Leads, R&D Medicine, and GCP Quality to lead the development and execution of Clinical Research Organization (CRO) and other key clinical vendor management structure for gene editing therapies. In addition, this leader will develop and foster preferred CRO and key vendor partnerships, lead governance forums, and is responsible for alliance management to drive strategic and operational efficiencies. This team member will ensure CRO and vendor activities meet Intellia and quality and global compliance standards
About You:
You are a subject matter expert (SME) and key clinical development team member who would embrace the challenge to create an innovative national and global outsourced development partnering approach to Intellia’s CRISPR/cas9 programs.
Minimum of a completed Bachelor's degree
10+ years' experience in strategic sourcing and alliance management experience in either a pharmaceutical/biotech company or CRO
Financial modeling and negotiation experiences
Thorough understanding of the global drug development process and project management skillset
Ability to identify, develop and help lead alternative operational approaches within the preferred partnerships, affording greater CRO/vendor accountability and responsibility
Solid organizational and communication skills, with the ability to successfully interface with the CRO and vendor executives, alliance manager and study teams
Ability to understand and respond to multiple external and stakeholder needs, manage and handle conflict constructively required
Ability to inform senior level leadership to all aspects of operational management, relationship management, and the preferred partner alliances
Ability to manage teams/individuals and provide career development and mentor staff
You will be responsible for:
Maintain an appropriate level of knowledge and understanding regarding project issues with the ability to "drill down" to detail as needed
In partnership with Strategic Sourcing, develop and implement analytical methods and metrics to improve CRO and vendor decision making, measure value, and enable a more strategic view of the outsourcing portfolio
Develop and implement processes for vendor identification, selection, and qualification while working colleagues across functions, including Clinical Operations, Finance, Strategic Sourcing, Legal, Quality Assurance, and other applicable functions.
Through alliance management, develop Key Performance Indicators to measure CRO performance and drive clinical development goals, operational efficiency, quality and compliance
Ensure KPIs and metrics from strategic CRO and vendor partnerships are appropriately quantifying the overall relationship and program health, ensure ability to quantify improvements and/or declines in: productivity, efficiencies, costs, and quality
Through alliance management, oversee all CRO and key vendor service lines and drive resolution of issues
Develop of tracking accrual processes with vendors to align with cross-functional requirements
Influence service providers to ensure outstanding partnering approaches leading to satisfaction across the Intellia stakeholder team
Ensure that clinical development and clinical operations project plans and timelines are thoroughly developed and vetted with the Intellia teams and CRO/vendor teams to meet/exceed the program objectives
Partner with CRO and key vendors to ensure line of site related to high-level program needs for resources and methods to ensure ability to take action when required to meet targets
Work effectively with Intellia teams, CRO alliance management, CRO/vendor teams to identify potential and actual issues and efficient issue resolution
Ensure continued success of strategic partnerships
Establish and lead governance across clinical supplier relationships (CROs and other key vendors) from inception to implementation, manage governance plan, and provide guidance to key Intellia stakeholders
Serve as an escalation point for key CRO and vendor relationships
Support purchase order processing
In partnership with Development Operational Excellence team members, establishes Intellia framework for applying industry best practices, utilizing external sources such as benchmarking, data, and processes to continually drive CRO and vendor improvements linked to an overall operational and program strategy
Lead the functional evaluation of CRO or key vendor processes or process improvement opportunities
Stays abreast of industry trends regarding the new specialty outsourcing services /solutions
Expertise regarding CROs, specialty vendors, including their leadership, organizational structure, business development strategies, financial health, operating strengths
In partnership with Development Operational Excellence, identify innovative new processes and tools to enhance clinical trial designs and execution
Provides leadership in a highly matrixed environment, who will mentor Clinical Operations professionals on CRO and vendor oversight and partnering approaches
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, development operations, clinical pharmacology, R&D Medicine, medical writing, project leadership, medical affairs, and regulatory affairs.
The Clinical Operations and Development Operations 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: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. 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.