Associate Director, Clinical Data Management

Location
Cambridge, MA, United States
Posted
Oct 15, 2020
Ref
909167329
Discipline
Clinical, Clinical Data
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Our mission:

Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

The Associate Director, Clinical Data Management is a part of the leadership team for the Data Analytics and Management department. They provide day to day oversight and/or coordination for the Data and Analytics project management, medical coding, data systems and quality, and implements program and study data strategies and data deliverables. They are a key component for operational excellence in partnership with Biostatistics, Clinical Operations, Statistical Programming, and other Global Development functions.

Responsibilities:
    • Ensures that adequate resourcing is available to meet milestones and performance/quality requirements across all drug programs.
    • Partners within Development Operations to ensure data strategy is aligned. Partners with cross-functional teams to ensure excellence in all aspects of statistical trial data acquisition and reporting as well as other functions to collaborate on work streams and initiatives that impact all of Global Development.
    • Supports all Data Management processes, standards, templates and best practices are applied fit for purpose to meet Program needs.
    • Manages, coaches, and supports staff in order to develop and maintain excellence.


Qualifications:
    • Minimum of a Bachelor's degree in Life Science, Computational Science, Computer Science, Information Systems, Computer Engineering.
    • 8-10 years relevant work experience in a leadership position within an organization with a focus on data management and analysis
    • Deep understanding of drug development and biopharmaceutical industry preferred; including all industry standards and guidances.
    • Strategic and critical thinking to drive direction of Dev. Operations
    • Ability to effectively lead and collaborate with various business functions
    • Ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
    • Extensive knowledge of clinical data management outsourcing with full-service, global CROs and FSPs Experience managing in a matrix environment and collaborating across functions and organizations, including demonstrated ability to influence without authority
    • Ability to successfully implement change management and lead others through change
    • Excellent written and oral communication skills
    • Demonstrated leadership, problem solving, conflict resolution, and team building skills
    • Lead or coordinate cross-functional initiatives/effective change management of process or technical improvements that improve Programming department standards or practices


#LI-KO1

What Intellia Stands For:

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 .