Director/Sr. Director, Clinical Operations jobs in United States
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Editas Medicine · 1 day ago

Director/Sr. Director, Clinical Operations

Editas Medicine is pioneering the power of CRISPR gene editing to develop transformative genomic medicines for serious diseases. The Director/Sr. Director of Clinical Operations will oversee the operational aspects of clinical trials, ensuring high-quality execution in alignment with corporate goals and regulatory standards.

BiotechnologyGeneticsHealth CareMedical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

Clinical trial managementICH-GCP guidelinesRegulatory requirementsClinical trial softwareIn-vivo gene editingLeadership skillsCommunication skillsOrganizational skillsProblem-solving skills

Required

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

Preferred

Experience with in-vivo gene editing clinical trials and multi-country clinical trials

Benefits

Blue Cross Blue Shield PPO Medical Plan
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
Flexible Paid Time Off policy

Company

Editas Medicine

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Editas Medicine is a clinical-stage genome editing company that develops genomic medicines for serious diseases.

H1B Sponsorship

Editas Medicine has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (19)
2023 (5)
2022 (8)
2021 (9)
2020 (16)

Funding

Current Stage
Public Company
Total Funding
$931.6M
Key Investors
Boris NikolicJuno Therapeutics
2023-06-14Post Ipo Equity· $125M
2021-01-21Post Ipo Equity· $231M
2020-06-23Post Ipo Equity· $215.6M

Leadership Team

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Gilmore O'Neill
CEO
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Charlene Stern
Executive Vice President & General Counsel
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Company data provided by crunchbase