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Clinical:
Vice President, Development Operations
At Intellia, we are revolutionizing medicine by harnessing the power of genome editing to develop potential cures. We bring new hope for people living with conditions including cancer, genetic disorders, viral infections, inflammatory disorders and many more.

Reporting to the Chief Medical Officer, the Vice President of Development Operations will be accountable for providing vision, leadership and strategic direction for the development, maintenance and execution of strategic planning and conduct of clinical trials globally from Phase 1 through 4 including non-interventional clinical studies as well as Investigator Sponsored Research. In alignment with the overall mission of Intellia, this position will also be responsible for the optimization of department processes, the implementation of project-specific strategies, and the development and execution of department strategies driven to increase productivity and quality, while decreasing cycle times and costs. The position requires strong collaboration, proven delivery and demonstrated experience managing, hiring, developing and retaining high performing and high potential talent.

Responsibilities:

  • Direct and oversee therapeutically focused Development Operations organization in the design and delivery of the clinical development programs including but not limited to Clinical Program Management, Data Analytics and Management, Document Management, Medical Writing, etc.
  • Develops and oversees the creation and execution of clinical development strategies and policies including budget planning, project delivery and people development
  • Oversees operational activities to ensure regulatory compliance
  • Leads the effective operational delivery and execution of clinical development programs on time within budget and with quality
  • Chairs the Protocol Review Committee and drives to achieve well designed protocols which accurately and effectively reflects the scientific hypothesis
  • Leads the development, management and delivery of standards, resources and non-drug project activities for the overarching Development Organization
  • Develops and maintains strong collaborations with key internal and external stakeholder
  • Develops an environment that enables the team to operate optimally in a matrix environment
  • Oversees the implementation of process improvement and develops a culture of continuous improvement
  • Effectively delegates responsibilities to achieve Global Development Operational and Clinical Project goal and ensures optimal oversight and supervision to ensure both achievement and growth
  • Oversee the successful recruitment, performance management, development and retention of a high performing team.
  • Responsible for the effective implementation and delivery of an optimal organization structure which effectively utilizes resources to meet the needs of the business including leveraging of contract and consultant resources

Qualifications:

  • 15+ years of pharmaceutical industry experience with at least 12 years of direct clinical trial management experience
  • Experience managing Phase I through Phase IV across the globe with a minimum of 5 years in a leadership role for global Phase II and III clinical program(s)
  • Experience in leading a multi-function organization in the management and completion of multiple or complex clinical program(s) and participated in a regulatory submission(s) (preferably US, Japan and EU).
  • Proven track record of successful studies (delivered on time, within budget, and with high quality).
  • Extensive expertise in developing operational strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial guidelines (including operational, regulatory, quality and legal aspects)
  • Strong therapeutic area knowledge and the ability to support the design and executive of clinical programs.
  • Proven track record of experience working with contract resource organization, functional service providers and third-party vendors
  • Proven track record of experience in multiple therapeutic areas or disease state/indications including life cycle management
  • Recognized leader in standard business procedures (SOPs, Global Regulations, Legal and Compliance, Outsourcing) and the application of procedures to the business. Considered a Subject Matter Expert and key contributor to initiatives. Leader and key contributor to initiatives and advancement of the clinical organization.
  • Extensive experience leading (Mid-Senior level) executives
What Intellia Stands For:

At Intellia, our mission is to develop potentially curative genome editing treatments that can positively transform the lives of people living with severe and life-threating diseases.

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us – trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded minds…free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously…and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts…with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards…even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.
 
POSITION: Full-Time, Exempt

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.

Intellia’s web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever’s privacy policy.

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.
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