Associate Director, Clinical Trials

Editas Medicine • Cambridge, MA

3d

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! Decoding the Role The key mission for this role in the next 12 months is to initiate and manage the Phase I study for our lead in vivo development candidate, EDIT-401, establishing early human proof of concept. You will enable high‑quality, compliant clinical trial execution by translating study plans into disciplined day‑to-day operations, proactively managing risks, and ensuring transparency across stakeholders. EDIT-401 is 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. Characterizing Your Impact As Associate Director, Clinical Trials, you will:

Requirements

• BA/BS degree in life sciences or related discipline
• 8+ years of experience in biotech or pharmaceutical clinical drug development
• Hands‑on experience supporting Phase 1–3 clinical trials
• Working knowledge of GCP, clinical trial systems, and regulatory requirements
• Experience working with CROs, vendors, and investigative sites
• Strong organizational skills with the ability to manage multiple priorities
• Proficiency with Microsoft Office and clinical data systems (e.g., CTMS, eTMF)
• Executional Excellence
• Delivers accurate, timely study execution
• Follows through on commitments and closes loops consistently
• Operational Discipline
• Maintains high standards for documentation, tracking, and compliance
• Balances attention to detail with an understanding of study priorities
• Risk Awareness & Problem Solving
• Flags issues early and proposes practical solutions
• Demonstrates sound judgment when navigating evolving study conditions
• Collaboration & Influence
• Builds productive relationships with cross-functional partners and vendors
• Communicates clearly, respectfully, and with purpose
• Communication & Transparency
• Shares timely, accurate updates on study status and risks
• Escalates issues appropriately and supports data driven decision making

Nice To Haves

• Experience in rare disease, specialty indications, and/or gene or cell therapy preferred

Responsibilities

• Execute EDIT-401 phase I trial with rigor and consistency
• Support planning, execution, and closeout of trials
• Ensure trial activities are conducted in accordance with protocols, SOPs, and GCP
• Maintain execution ready study plans
• Assigned clinical trials are executed according to plan, timeline, and quality expectations
• Study documentation and systems remain accurate and up to date
• Proactively manage study level risks and issues
• Identify and escalate potential impacts to timeline, cost, or quality
• Support development of mitigation plans in partnership with study leadership
• Enable cross-functional coordination
• Communicate effectively with Clinical Operations, Data Management, Regulatory, CMC, and external partners
• Support alignment across stakeholders on study priorities and expectations
• Stakeholders have clear visibility into study progress, metrics, and challenges
• Study updates support effective decision‑making
• Support vendor and site oversight
• Assist with vendor and site budgets, supporting invoice and budget activities
• Assist with site management activities, including review of monitoring reports and tracking site visits
• Ensure inspection ready trial execution
• Maintain Trial Master File completeness and accuracy
• Support compliance activities, quality issue identification, and resolution
• Reduce surprises through disciplined execution
• Ensure timely updates to CTMS, clinical trial registries, and internal systems
• Communicate study status, metrics, and emerging issues with clarity and urgency
• Maintain trial inspection-readiness
• Contribute to operational excellence
• Support development of study tools, templates, and training materials
• Contribute to process improvements, SOPs, and departmental initiatives

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 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: 101-250 employees