What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) 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 trans-formative, durable, precision genomic medicines for many diseases.

We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before.

Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world. If the answer is yes, then Editas Medicine is the place for you.

Position Summary

The Director, Clinical Compliance will possess knowledge and understanding of Clinical Development, ICH GCP, clinical trial management, CRO and vendor oversight practices, and inspection readiness activities. The successful candidate requires a proactive, quality focused mindset, skilled at both understanding and evaluating internal procedures and policies as well as local and global regulations and processes as trials advance through development. The position requires a collaborative partnership with cross-functional team members, and significant stakeholder management throughout the organization.

Key Responsibilities:

• Evaluate, write and/or revise relevant standard operating procedures and work instructions.
• Lead inspection readiness planning and activities.
• Lead TMF oversight efforts, by establishing standard process for oversight and compliance checks to established process.
• Collaborate cross functionally to evaluate and develop strategic action plans to ensure compliance and oversight with clear and measurable outcomes/key quality indicators.
• Liaison with study teams and outsourced partners/ vendors to establish/refine standard reporting.
• Design and implement vendor and documentation oversight procedures and effectiveness checks.
• Partner with Clinical Quality Assurance to action and respond to internal audits, CAPAs and effectiveness checks.
• Identification of gaps/risks in process, procedures and proactively planning solutions and actions to mitigate gaps or risks.

Qualifications

• Bachelor’s degree required. Master’s degree in Clinical Sciences, Public Health, Healthcare Administration highly preferred.
• Minimum of 8 years of experience in clinical research with at least 6 years of direct responsibility and experience in a clinical compliance role,or mixed with trial management lead responsibilities.
• Excellent written and oral communication skills exemplified by timely follow-up; meeting participation; effective negotiating skills; the ability to summarize and frame issues, discussions, conclusions; and development of effective communication plans.
• Advanced working knowledge of GCP/ICH/TMF and other applicable regulations/guidelines
• Ability to manage multiple projects in a fast-paced environment
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

Benefits Summary:

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.