Associate Director, Clinical Trials

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:

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

Requirements

The Ideal Transcript

To thrive in this role, you’ll need:

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

You’ll also demonstrate the following skills and behaviors:

Executional Excellence

• Delivers accurate, timely study execution
• Follows through on commitments and