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 transformative, 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.

Key Responsibilities & Accountabilities:

• Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise, and knowledge, along with optimizing CRO resources, expertise and knowledge.
• Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies
• Provide leadership and input into global subject/patient recruitment plans.
• Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor.
• Manage strategic study operations including study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
• Participate in Case Report Form design, user acceptance testing in partnership with data management
• Lead the development of contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies.
• Budgets, timelines, and forecasts preparation for clinical studies.
• Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Regulatory, Medical Affairs, which may include leading sub- teams and/or acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notifies finance of projected cost over/under expenditure.
• Generate country specific Informed Consent Form(s).

Knowledge, Skills & Capabilities:

• Strong regulatory knowledge, including Good Clinical Practices (GCPs)
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning, and problem-solving ability.
• Excellent communication (written and verbal) and presentation skills along with leadership qualities.
• Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
• Apply project management best practices to programs. Experience in novel clinical drug development.
• Experience with protocol, ICF, CRF, CSR development and review.

• Strong organizational skills and ability to deal with competing priorities.
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
• U.S. employees must be fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC).

Education & Relevant Work Experience:

• Bachelor’s Degree is required. An advanced degree in a scientific and/or business/finance discipline is preferred.
• 3+ years of clinical research experience gained with a CRO or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies. Experience in rare diseases and/or difficult to recruit patient populations preferred.
• 2+ years clinical project management experience with global clinical studies

Physical & Travel Requirements:

• Ability to travel (no more than annual average of 20%

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.