Director/Sr. Director, Clinical Operations

Editas Medicine • Cambridge, MA

5h

About The Position

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.
Why Choose Editas?
At Editas Medicine, we’re a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!
This role is to help advance our lead in vivo development candidate, EDIT-401, a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. The company is very excited by the potential of this experimental treatment which has demonstrated the ability to reduce mean LDL cholesterol levels by over 90 percent in non-human primates. If you are a candidate excited to help push the boundaries of what’s possible in medicine, apply now.
Decoding The Role:
The Director/Sr Director Clinical Operations will oversee and manage the operational aspects of Editas’ clinical trial including planning, execution and delivery in alignment with corporate goals. The Director/Sr Director Clinical Operations will be responsible for executing high-quality clinical trials. This individual will play a pivotal role in ensuring the successful execution of the study adhering to regulatory standards and meeting project timelines and goals.

Requirements

• Bachelor's degree in a scientific or healthcare-related field (advanced degree preferred).
• 10+ years of experience in clinical trial management, specifically in early phase studies.
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial operations.
• Strong leadership skills with the ability to effectively influence teams and collaborate across departments.
• Excellent communication, organizational, and problem-solving skills.
• Proficiency in clinical trial management software.

Nice To Haves

• Experience with in-vivo gene editing clinical trials and multi-county clinical trials

Responsibilities

• Partner with Executive leadership and Program team to ensure cross-functional collaboration and cohesive planning and execution of the EDIT-401 program.
• Proactively identify program-level risks, offer mitigation strategies, and support implementation
• Manage the planning, study-startup, execution and closeout of Editas’ Clinical Trials. Solve study-related issues and serve as escalation point as needed.
• Oversee and collaborate with CRO partner(s), vendors, and other consultants involved in the trials to execute high-quality clinical trials and ensure study start up and site activation goals are met.
• Monitor and track study progress, ensuring accurate data collection and reporting.
• Contribute to the preparation and review of study-related documents such as study manuals, consent forms, protocols etc.
• Ensure the Trial Master File is in compliance with ICH/GCP and company SOPs.
• Work cross-functionally with key internal partners (data management, quality assurance, clinical supply, clinical development) to meet clinical trial enrollment timelines and goals.
• Support the planning and execution of meetings including but not limited to meetings with Key Opinion Leaders, Investigator Meetings, Site-Initiation Visits, Steering Committee Meetings, etc.

Benefits

• Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 251-500 employees