Director Clinical Operations, Trial Master File

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 a Director, Clinical Operations, Trial Master File within the Clinical Operations organization, you will report to the Vice President, Development Operations, and manage your own team of employees that spans across varying levels of skills and experience.  As the business owner of the TMF, you will be responsible for ensuring that clinical studies have comprehensive, quality TMFs, which are inspection-ready with a strong adherence to SOPs, good clinical practices, good documentation practices, International Council for Harmonization E6(R2), and ALCOA+ standards.

As the TMF subject matter expert (SME), this leadership position supports, consults, and provides TMF guidance to accountable functions during the study and program lifecycle, including planning the eTMF study structure, maintenance, study teams and SME assignments.

You will be responsible for:

• Working with the stakeholder team to create the near term and longer term TMF vision and operational activities with an eye towards inspection readiness and compliance

• Oversee contract research organizations (CROs) TMF teams, ensuring quality performance

• Supporting, consulting, and coordinating with each Intellia and CRO clinical study team to establish the structure and plan for the TMF

• Leading the cross-functional TMF oversight through the life cycle of the study (planning, set-up, oversight, closeout, archival)

• Ensuring Intellia’s cross-functional TMF business process and operating model is followed for each study

• Serving as a key subject matter expert for the eTMF system and identify areas for continuous improvement for management of the system

• Providing input on department-wide operating procedures, work instructions, best practices, training materials, systems, and tools

• Managing the eTMF system, ensuring study TMFs are built according to the specific study architecture for inputs including: country and site documents; CRO, key vendor and account documents; study team documents, Intellia’s CRO oversight documents

• Identifying and targeting areas for improvement regarding key TMF metrics/KPIs/KQIs, and creates reports to measure and track progress

• Leading projects to create, maintain and improve milestones and expected document tracking and timeline reports and dashboard reporting

• Works with the Intellia cross functional teams and CROs teams, as needed, with a focus on preparing and supporting study teams for GCP and pre-approval related inspections on study TMF compliance and completeness

• Mentors junior members of the Intellia TMF team and leads stakeholder TMF and/or documentation and records management projects (such as quality projects to align with new practices or regulations, continuous inspection readiness practices, CRO or key vendor projects, IT projects, company-wide documentation or archiving projects)

About You

You are an SME and clinical operations leader who would embrace the challenge to create an industry-leading approach to TMF and archiving for our growing CRISPR/cas9 portfolio.

• A Bachelor's degree in the areas of life science, social science, or computer science

• At least 10 years of experience in trial master file/records management and inspection readiness within clinical operations or a related quality/compliance position within the pharmaceutical industry

• Experience with eTMF systems; installation/validation, user uptake, and maintenance

• Experience with both domestic and international trials

• Knowledge of the drug development process including Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) requirements; experience participating in audits and or inspection is a plus

• Understanding of the clinical trial stages, such as study start-up, maintenance, and closeout stage

• Ability to work independently and collaboratively with internal teams, CROs and other key vendors, as required, in a fast-paced, multi-disciplinary team environment.

• Exemplary critical thinking, planning, organization, and time management skills including the ability to support and prioritize multiple projects.

• Solid communication and presentation skills

• Strong change management skills with the ability to be an adaptable leader

• Proficient in the use of the Microsoft Office Suite

Meet your future team:

The Clinical Operations 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.  The experienced team is led by our Vice President, Development Operations; a pharmacist with over 25 years’ experience in biotech new product development.  Other team members have 5-15 years of similar new product development experience in a biotech-outsourced operational model setting. 

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Covid-19 Vaccination Policy: Effective Monday, January 3, 2022, all Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. 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.