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What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. Were 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. Were 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:

The Senior Director Clinical Operations is a responsible member of the compound development team dedicated to the development and execution of clinical trials and the clinical and operational implementation of one or more complex compound programs. These responsibilities include:

• Provide strategic and tactical direction to project teams as assigned.
• Direct line management and development of clinical operations staff: mentoring, modeling key behaviors and providing ongoing support and guidance
• Assist VP of Clinical Operations to support programs, department strategy, implementation of initiatives and team building, etc as needed.
• Evaluate CROs and other vendors for new or ongoing performance in Editas Medicines clinical trials.
• Provide strategic advice to project teams and senior management including evaluation of risks/mitigations, budgets and timelines of clinical development plans
• Active relationship building and management with cross functional teams, Editas leadership and vendors (internal and external)
• Provides oversight of the conduct of all program clinical trials with quality mindset, including establishment of key metrics, quality indicators and action plans.
• Drive the oversight for clinical trial monitoring activities in accordance with Editas Medicine and ICH/GCP standards and in compliance with the approved monitoring plan and SOPs.
• Oversight of assigned program clinical Trial Master File in concert with development partners and/or CROs for all Editas Medicine Clinical programs to ensure accuracy and completeness of the documentation.

• Assist/Drive the implementation of inspection readiness for assigned program with key stakeholders
• Represent the study operations team at the program team and other program related strategic meetings
• Drive study milestones and study metrics in collaboration with the study team.
• Participate in IND, Regulatory agency briefing books, meeting planning, BLA preparation, etc., and any other clinical/regulatory activities as needed.

Requirements

Knowledge, Skills & Capabilities:

• A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required.

• Experience in Hematology/Oncology, Neurology, Immunology, Ophthalmology and Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy.
• Experience with all phases of clinical drug development including global regulatory submissions preferred.
• Strong communication, organizational and interpersonal skills are required.
• Successful work experience in a matrix team environment with cross functional teams is required.
• Independent decision-making and analytical skills are required to operationalize and move the clinical trials forward.
• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
• Strong Understanding of clinical efficacy and safety data, interpretation of tables and listings, and analysis to ensure clinical data integrity.
• Proficiency in managing and developing clinical operations personnel and CROs

Education & Relevant Work Experience:

• A minimum of a Bachelors Degree is required preferably in a Scientific or Technical Discipline. Advanced degree (MS, RN, PhD or PharmD) is preferred.
• A minimum of 15 years of experience in the Clinical Research & Development/Clinical Trials environment is required including 10+ years of clinical study/program management.

Physical & Travel Requirements:

• Ability to travel up to 20% of time both domestic and/or international.

Benefits

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.