Demo

Director, Standards and Compliance

Intellia Therapeutics
Cambridge, MA Full Time
POSTED ON 1/19/2025
AVAILABLE BEFORE 4/18/2025

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 wantall ofour 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.

Director, Standards and Compliance

As Director, Standards and Compliance within the Development Operations organization, you will be supporting the Development Operations Leadership Team and Development Operations / Clinical Operations Infrastructure. This is a key member of the Development Operations team and will partner closely with the Clinical Operations, R&D Medicine, Biometrics, Drug Safety & Pharmacovigilance (DSPV), Information Technology (IT), and the Intellia Quality organizations to build and support activities related to compliance and operational excellence.

Duties / Responsibilities

  • Coordination of activities related to Development controlled documents (policies, procedures, forms, etc.) to confirm consistency with regulations, Intellia processes, industry standards and to support inspection readiness.
  • Lead internal assessments of compliance with external and internal standards while working with key stakeholders to create processes and documentation of requirements.
  • Support Clinical Operations (e.g. Clinical Leads) related to compliance requirements with vendors (e.g. CROs) and other operational processes as appropriate.
  • Coordinate with key stakeholders to develop, assign and implement requirements related to Development infrastructure while supporting training and compliance requirements for Development Organization.
  • Lead and participate in strategic discussions and initiatives related to Issue and Risk oversight, management and resolution with relevant key stakeholders.
  • Identify innovative and robust processes and tools to enhance compliance and documentation of regulated processes.
  • Support the direction to the organization in ensuring inspection readiness of the organization, its vendors, and its clinical investigators / sites in conjunction with Clinical Operations, Clinical Quality and other applicable functions.
  • Support a culture of continuous improvement, enhanced compliance and performance excellence; act as a change champion and effectively lead change.
  • Maintain awareness of biopharmaceutical business, operational trends, and external organizational developments to help define future strategic direction.
  • Provide leadership in a highly matrixed environment and assist in mentoring Clinical Operations team members.

Supervisory Responsibilities

Role may be required to manage people.

Requirements

Skills / Abilities

  • 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.
  • Education / Certifications

    BA / BS in related discipline; advanced degree preferred

    Experience

    10 years) experience with a CRO or biopharmaceutical company with strong knowledge associated with GCP and inspection readiness activities

    Physical Requirements

    Prolonged periods of sitting at a desk and working on a computer

    Manual dexterity for keyboarding; may include repetitive movements.

    Covid-19 Vaccination Policy : All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

    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.

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Director, Standards and Compliance?

    Sign up to receive alerts about other jobs on the Director, Standards and Compliance career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $195,602 - $261,706
    Income Estimation: 
    $244,337 - $383,019
    Income Estimation: 
    $163,270 - $214,905
    Income Estimation: 
    $195,602 - $261,706
    Income Estimation: 
    $123,739 - $165,355
    Income Estimation: 
    $163,270 - $214,905
    Income Estimation: 
    $150,417 - $183,047
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Intellia Therapeutics

    Intellia Therapeutics
    Hired Organization Address Cambridge, MA Full Time
    Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives ...
    Intellia Therapeutics
    Hired Organization Address Cambridge, MA Full Time
    Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives ...
    Intellia Therapeutics
    Hired Organization Address Cambridge, MA Full Time
    Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives ...
    Intellia Therapeutics
    Hired Organization Address Cambridge, MA Full Time
    Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives ...

    Not the job you're looking for? Here are some other Director, Standards and Compliance jobs in the Cambridge, MA area that may be a better fit.

    Director, Standards and Compliance

    BioSpace, Cambridge, MA

    Director, Standards and Compliance

    Intellia, Cambridge, MA

    AI Assistant is available now!

    Feel free to start your new journey!