Director, Clinical Operations

Location
Cambridge, MA, United States
Posted
Jul 14, 2021
Ref
R194
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
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 At Intellia:

The Director, Clinical Operations is an integral part of the leadership team for the Clinical and Development Operations organization. They are a vital team member for operational excellence of study execution in cross functional collaboration with Data Management and Biostatistics, Medical, Regulatory Affairs, Clinical Pharmacology, Clinical Supply and CMC, Drug Safety and Pharmacovigilance and other Global Development functions. They provide day to day operational oversight and/or coordination for clinical study execution

In this opportunity, your main responsibilities will include:
  • Executes the day-to-day operations of a clinical studies from the protocol concept through the clinical study report per established project team goals and objectives in compliance with applicable GCP/ICH guidelines, regulations, SOPs and other regulatory requirements across the globe.
  • Develops and manages comprehensive study timelines and metrics
  • Drives selection and management and oversight of external vendors including planning, executing study-specific meetings, key performance indicators and participates, as applicable, in vendor management governance.
  • Co-leads development of clinical study synopsis and protocol in conjunction with the clinical development plan
  • Develop and manage study budget and maintain within financial goals; Responsible for study budgets up to $100M
  • Participates in the planning of quality assurance activities and coordinates resolution of audit findings.
  • Coaches and provides guidance to clinical staff, may have management responsibilities for clinical trial management staff
  • Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
  • May serve as subject matter expert (SME) in one or more areas such as development of SOPs, systems, tools, best in class standards for operational execution etc.


About You:

If you enjoy working in a fast-paced Biotech environment, have a combination of experience across study, program, and functional levels within Development Operations, then this could be just the job for you! Do you have the following?
  • Bachelor's Degree in science or a health-related field is required; advanced degree preferred
  • 6 to 10 years of direct clinical trial management experience in the biotech/pharmaceutical industry
  • Must have multi-trial, Phase 2/3, global experience as a lead study manager (early phase development is a plus)
  • Experience in multiple therapeutic areas or disease state/indications desirable, including life cycle management
  • Strong management skills, and ability to effectively lead and collaborate with both internal and external stakeholders
  • Excellent written and oral communication skills
  • Demonstrated leadership, problem solving, conflict resolution, and team building skills
  • Excellent knowledge of GCP, ICH, and FDA regulations with direct experience with health authority inspections
  • Potential ability to travel up to 20%


Meet Your Future Team:

This role will report directly to the Senior Director, Clinical Operations. As part of the greater Development Operations team, the Clinical Operations group will continue to expand as our clinical trial portfolio of work continues increase. The Clinical Operations groups as well as the Development Operations team members bring an extensive range of experience and knowledge to the clinical development process. As a key member of this team, you will join a group of passionate individuals who enjoying working with one another.

While the team is currently working virtually, we are tentatively planning a return to the office in September. Although in a virtual environment, the group and the Intellia organization has made it a priority to continue to foster a sense of community. This includes team all-hands meetings, virtual happy hours, game nights, and more! You can expect to join a hardworking, collaborative environment driven on bringing potential new therapies to patients and their families.

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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.